Category: 3. Business

Introduction

Chronic urinary conditions, such as benign prostatic hyperplasia (BPH), necessitate ongoing patient self-management, akin to other chronic diseases such as hypertension, diabetes, and asthma. Despite this need, there is a notable lack of tools enabling patients to monitor and manage urinary symptoms autonomously at home. This absence increases the risk of symptom progression and the onset of secondary urinary disorders. Even in cases where pharmacological treatments are suboptimal, patients lack effective methods for self-monitoring [].

Postoperative urinary complications can also occur following interventions for prostate enlargement. The inability of patients to self-assess their condition may result in delayed recognition of issues, potentially necessitating urgent interventions, such as urethral catheterization []. Traditional methods, such as the use of a urination diary, which requires patients to record their symptoms for several days using paper and a measuring cup, are cumbersome and often impractical. If these records are misplaced, patients lose the ability to accurately track their urinary habits, and health care professionals face additional burdens in manually calculating metrics such as daily and nocturnal urine output.

The integration of digital therapeutics presents significant benefits, including the absence of toxicity and adverse side effects, minimal costs, and continuous real-time management []. These tools facilitate 24-hour monitoring of patient status and allow for personalized patient analytics by empowering patients to actively participate in data collection and management. Individuals can actively engage in self-health monitoring and retrieve evaluation results before consulting medical personnel, reducing time consumed during in-person visits to clinics and overcoming geographic barriers when physical presence is limited due to infection or regional availability of medical services.

As an attempt to address the needs of both clinicians and patients for a personalized device to measure and monitor voiding-related outcomes during and after treatment, an acoustic uroflowmetry was incorporated into a mobile app [,]. Uroflowmetry, which is a pivotal test for the evaluation of lower urinary tract function and voiding patterns during diagnosis and treatment, requires the patient to visit the hospital and undergo testing in a controlled setting. Moreover, single measurements obtained in a hospital setting may not reflect a patient’s usual voiding patterns. Acoustic uroflowmetry using mobile apps provides a practical alternative to replace conventional methods, allowing repeated measurements in familiar home environments, enabling remote monitoring as well as accessibility for patients, and improving efficiency in clinical practice.

However, despite worldwide interest and the development of similar tools, no study has generated data on the comparative outcome between mobile uroflowmetry and in-office measurements for surveillance of posttreatment change. This study compares an acoustic analysis–based uroflowmetry, which calculates urine volume by recording sounds with a smartphone, with a conventional physical urinary flow test machine in patients undergoing surgery for BPH. The aim is to evaluate whether traditional in-office tests can be effectively replaced.

Methods

Ethical Considerations

This study received approval from the institutional review board of Seoul National University Bundang Hospital (B-2207-769-305). All data analyzed in this research were anonymized, and informed consent was obtained from all patients participating. The participants received monetary compensation of South Korean ₩ 100,000 (approximately US $67.90) for hospital visitation and traveling fees during the entire study. To ensure privacy, personal identifiers were fully removed, and the analysis was conducted anonymously. All procedures adhered to the relevant ethical guidelines and regulations. A STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist was submitted as supplementary material ().

Study Design and Population

Patients diagnosed with BPH planning to undergo surgery (transurethral resection of prostate [TURP]) at 3 tertiary institutions (Seoul National University Bundang Hospital, Ewha Womans University Medical Center, and Kyung Hee University Medical Center), who were older than 20 years, were screened for eligibility and enrolled after obtaining informed consent. This study was designed as a prospective pilot observational study in a single cohort without a control to validate the efficacy of mobile uroflowmetry measurements compared to conventional methods conducted in an office. On the basis of previous literature [,] suggesting a moderate correlation (expected r=0.6), a minimum of 20 patients would provide 80% power to detect a statistically significant correlation at a 2-sided α level of .05. To improve the precision of the correlation estimate, allow for potential measurement failure or incomplete data, and support the feasibility of future definitive studies, we increased the target enrollment to 40 patients. During the first outpatient visits, patients planning to undergo surgery for BPH were recommended for screening and enrollment, if eligible. After initial study enrollment, individual mobile devices with the app installed were distributed for preoperative evaluation of voiding patterns and parameter measurements for at least 72 to 96 hours before surgery. In-office measurements were also conducted for comparison. Additional app measurements were taken for the same 4-day periods after 2, 6, and 12 weeks of surgery and compared to conventional uroflowmetry measurements conducted at the same intervals of outpatient clinic visits. International Prostate Symptom Scores (IPSS) and uroflowmetry parameters, including maximum flow rate (Q_max) and voided volume (VV), were collected at each visit. At the time of study termination at 12 weeks, all patients completed a written survey using a 0-to-10-point scale for satisfaction. All enrolled participants completed the study protocol, and there were no missing data for any of the outcome variables over the 12-week follow-up period.

In-Office and Mobile App–Based Uroflowmetry

All patients uniformly underwent an in-office conventional uroflowmetry (CubeFlow_S; MCube Technology) at each visit before and after treatment according to the study schedule. Additional app-based uroflowmetry measurements were obtained using the sound-based mobile app proudP (Soundable Health, Inc), a Food and Drug Administration–listed class 2 uroflow meter that has been validated for flow prediction and VV measurements in previous studies [,]. The acoustic flow measurement system uses a wireless, smartphone-based approach with recording capabilities to analyze urinary flow. Acoustic data were captured in real time using a smartphone app. From the recorded sounds, parameters such as urinary volume, flow-related metrics (eg, peak urinary flow and average urinary flow), urinary flow patterns (eg, continuous or intermittent), and time-related parameters (eg, maximum voiding time and voiding duration) were calculated. Acoustic characteristics were assessed using audio processing, signal preprocessing, and spectral analysis techniques. A predictive model was then used to estimate urinary flow and associated parameters. Postprocessing produced data regarding accuracy and voiding metrics.

To minimize variability due to height or ambient surrounding noise, patients were instructed to ensure the restroom environment was as quiet as possible and place their smartphone approximately 80 cm away from the toilet before using the mobile app. They were then guided to launch the mobile uroflowmetry. While standing in front of the toilet, patients urinated, aiming for the center of the bowl, when possible, to optimize measurement accuracy. Before the actual experiment, all participants received standardized instructions on how to perform uroflowmetry using the in-hospital system to ensure consistent and reliable data collection.

The recorded sounds were analyzed using audio editing software (Audacity, version 2.2.2; Audacity Open Source Team and GoldWave). Signal preprocessing and postprocessing as well as the development of flow prediction models were conducted using MATLAB (version R2017b, 9.3.0; MathWorks, Inc) and Python (Python Software Foundation). To enhance accuracy, the acoustic analysis algorithm included preprocessing and postprocessing refinements to eliminate short-term artifacts and outliers, correct background noise levels, and remove specific noise bands. Validation of uroflowmetry parameters, including Q_max and VV, was performed in separate studies [].

Survey Method

To assess patient satisfaction with the mobile uroflowmetry system, we developed a brief, study-specific questionnaire tailored for use in this pilot validation study, and a single-session self-administered survey was conducted at the final in-office visit. The questionnaire was created collaboratively by the study investigators, including urologists and research coordinators, based on their clinical experience and anticipated domains of usability (eg, convenience, clarity of instructions, and perceived reliability of the mobile app). Patients were asked whether the use of the app-based monitoring (1) allowed better self-understanding of their clinical status, (2) improved the clinician’s understanding of their status, (3) was easy to use, and (4) was overall satisfactory. All scores were provided as a numerical value on a point scale ranging from 0 to 10.

Statistical Analysis

Independent 2-tailed t tests and equal-variance tests were used to assess whether there were statistically significant differences between conventional measurements obtained via in-office uroflowmetry–based and acoustic uroflowmetry–based mobile data collection. These tests were selected to validate the statistical characteristics of uroflowmetry measurements, including Q_max as the primary comparative factor, with VV and IPSS change as secondary measures. The analysis and calculations were conducted using Python (version 3.6.9; Python Software Foundation), along with the SciPy (version 1.5.14; Python Software Foundation) scientific computing package and R (version 4.3.1; R Foundation for Statistical Computing). Categorical variables were analyzed with chi-square and Fisher exact tests, and ANOVA was used for additional continuous variables. Normality was assessed using the Shapiro-Wilk test, and homogeneity of variance was evaluated with the Levene test. In cases where assumptions were not met, appropriate nonparametric alternatives (eg, Mann-Whitney U test and Kruskal-Wallis test) were used. Further assessment of the agreement of the 2 different uroflowmetry parameters was performed with Bland-Altman analysis, with the mean difference and 95% limits of agreement (defined as mean difference of +1.96 and –1.96 × SD of the paired differences) calculated according to standard procedures. To interpret clinical relevance, we adopted a provisional threshold of +10 mL/s and –10 mL/s for Q_max, as variations of this magnitude are generally regarded as unlikely to change the clinical interpretation of flow pattern or degree of obstruction in typical urodynamic practice [].

Results

A total of 46 treatment-naive patients with symptomatic BPH undergoing endoscopic surgery were screened, and 41 (89%) patients were finally enrolled, with 5 (11%) declining participation. The mean age of all patients was 67.4 (SD 5.5; range 58-79) years. Assessment of the accuracy and representability of acoustic uroflowmetry as compared to in-office measurements for Q_max resulted in a Pearson correlation of 0.743 (P<.001; ). The mean of the difference observed in the Bland-Altman analysis was 1.57 (SD 7.0), with upper and lower limits of agreement of 15.4 and –12.2, respectively.

Improvement in IPSS over the 12-week period was significant for all patients who underwent TURP for all specific parameters, including total IPSS and quality of life, as well as for both obstructive and irritative symptoms (; Figure S1 in ). Mean improvement of 10.2 and 8 points was observed for total IPSS and obstructive IPSS, respectively (both P<.001).

Specific uroflowmetry parameters, as measured from the mobile device, well reflected improvements in symptom scores, with baseline mean Q_max of 12.8 (SD 4.1) improving to 20.3 (SD 5.4) at the end of the study, similar to results measured from in-office uroflowmetry, which showed a similar range of improvement from a mean of 13.0 (SD 6.3) to 23.2 (SD 9.8) in the same period (). No significant differences in VV were observed.

Changes in IPSS to Q_max as measured by the app were significant overall, with modest correlation () and the highest Pearson correlation of –0.490 for obstructive IPSS, followed by –0.478 for total IPSS (Figure S2 in ). Individual questions for intermittency and weak stream showed the highest correlation as measured by acoustic uroflowmetry (r=–0.490 and r=–0.580, respectively).

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When stratified by prostate volume, patients with larger prostates (≥80 mL) demonstrated greater improvement in Q_max at 12 weeks compared to those with smaller prostates (<80 mL). Mean Q_max in the 80 mL or greater prostate volume group increased from 13.1 (SD 4.8) mL/s at baseline to 22.8 (SD 4.4) mL/s at 12 weeks using the app-based method compared with a 10.1 mL/s increase measured by in-office uroflowmetry. In contrast, patients with prostate volumes less than 80 mL showed a smaller mean increase (app: mean 13.0, SD 4.0 to mean 19.4, SD 5.3 mL/s; in office: mean 12.6, SD 5.3 to mean 22.8, SD 11.9 mL/s). Correlation between the 2 methods was also slightly higher in the larger prostate subgroup (r=0.692) than in the smaller prostate group (r=0.642; both P<.001), suggesting more consistent agreement in men with enlarged glands (Table S1 in ).

Further stratification by severity of IPSS showed both improvements reflected in patients with either moderate or severe IPSS, with a high Pearson correlation value of 0.751 and 0.734 in each group (all P<.001; Figure S3 in ).

Survey results for patient satisfaction are shown in . All patients were highly satisfied with the measurement process and felt the app was easy to use. Subjective assessment of the additive value of the app was remarkably high. No difference in the use of the app by men aged 70 years and older was observed.

A sample representation of post-TURP changes and measurements conducted with the mobile uroflowmetry is presented in , where a patient’s preoperative obstructive patterns and postoperative improvement of uroflowmetry plateau are well displayed, with an initial Q_max of 10.2 and VV of 297 improved to 20.0 and 324, respectively, at 12 weeks after surgery.

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Discussion

Principal Findings

This is the first prospective clinical trial to evaluate the effectiveness and feasibility of an acoustic app-based uroflowmetry to monitor patients after clinical intervention. The mobile measurements conducted at home were clinically reliable, with a strong correlation to IPSS improvement after surgery, also reliably reflecting the absolute improvement in Q_max with TURP, especially for patients with obstructive IPSS. Q_max, as measured with the app, showed consistent change regardless of prostate size as well as when stratified by severity of IPSS, suggesting that the technology can be reliably used in a wide spectrum of male patients with lower urinary tract symptoms. Older patients were equally satisfied with the process and felt at ease using the app, suggesting that as long as the patient is familiar with a mobile device, uroflowmetry measurements for clinical observation can be effectively conducted without technical difficulty.

Lee et al [] performed a prospective comparative analysis in 16 male pediatric patients using the same app to validate the technology’s strong correlation to standard measurements. A smartwatch-based uroflowmetry model was constructed by a Spanish team after extracting acoustic features from voiding stream sounds, similar to the method described in this study, and it displayed good correlation []. El Helou et al [] used a similar approach in 44 healthy young men, and by mapping total sound energy with VV, the model was successfully able to estimate flow rate with a mean absolute error of 2.41 mL/s. Dawidek et al [] compared a conventional uroflowmetry with an audio-based uroflowmetry (TeleSonoUroFlow) app, achieving a poor correlation for Q_max (r=0.12) and failing to show consistent results despite modest improvement in healthy individuals. However, these studies, by design, performed only comparisons of the mobile uroflowmetry versus conventional clinic-based measurements and did not evaluate whether the technology could accurately represent the changes that occur during and after treatment. Overall, a recent meta-analysis by Rangganata et al [] showed the efficacy of mobile acoustic uroflowmetry in male participants to be strong, with positive correlation for VV and Q_max, as shown in our study, as well as for other uroflowmetry parameters, including voiding time and average flow. Bladt et al [] also showed that at-home measurements can be as useful or even more representative of voiding patterns than hospital measurements, as shown in our sample patient (), in whom multiple app-based measurements were more informative and reliable in tracking voiding pattern changes.

The importance of uroflowmetry and changes in its parameters are paramount in assessing the success and efficacy of surgical treatment in BPH [-]. While preoperative Q_max values typically range from 6.18 to 8 mL/s, Q_max improves significantly after surgery, with studies reporting improvement up to 26.43 mL/s [,]. The average flow rate shows similar changes, with preoperative values from approximately 4.44 to 13.48 mL/s after TURP []. The patients in our cohort showed similar improvement, with most change found in large BPH. The significance of our study lies in the fact that mobile uroflowmetry was sufficient to measure the changes in such parameters after surgical intervention and reflect the measurements performed at outpatient visits, validating the efficacy for use in actual clinical practice. Unlike previous studies that primarily validated acoustic uroflowmetry in healthy volunteers or patients with stable lower urinary tract symptoms, this study evaluated its performance in a postoperative population undergoing active recovery after prostate surgery. In this context, uroflow parameters fluctuate considerably due to progressive relief of obstruction, healing of the bladder neck, and adaptation of detrusor contractility. Demonstrating consistent agreement between acoustic and conventional measurements across this dynamic postoperative trajectory supports the robustness of acoustic uroflowmetry beyond static or screening scenarios. Therefore, our findings extend the clinical applicability of this technology to longitudinal monitoring in the perioperative setting, where repeated, home-based assessments can provide meaningful insights into functional recovery. However, while tracking changes was significantly well correlated, our results suggest caution when considering complete replacement of conventional measurements, as the limits of agreement in this study (–12.2 to 15.4 mL/s) slightly exceed the prespecified reference range of +10 mL/s and –10 mL/s, suggesting that although the 2 devices show close overall agreement, individual measurements may differ modestly in real-world clinical use. This difference may reflect consistent measurement conditions at home despite pretraining and guidance during the trial or may result from intraindividual variability in uroflowmetry, which by itself is known to reach approximately 10 mL/s []. This finding highlights the need and necessity for multiple measurements in a single individual during clinical evaluation and monitoring, underscoring the importance and potential for remote mobile measurements.

Another interesting point to mention was that a stronger agreement was observed in men with larger prostates or higher baseline IPSS. This may reflect the more stable and reproducible flow characteristics typically seen in obstructive voiding patterns, in which urinary flow is typically slower and of longer duration, producing clearer and less noisy acoustic signals that enhance the reliability of the app’s waveform detection. Conversely, individuals with smaller prostates or milder symptoms often exhibit higher peak variability and shorter flow times, which can amplify measurement discrepancies between acoustic and conventional methods. These subgroup findings suggest that app-based uroflowmetry may be particularly accurate for monitoring patients with clinically significant bladder outlet obstruction, while careful interpretation is still warranted in those with near-normal flow profiles.

Beyond demonstrating technical validity, this study also highlights the digital health potential of acoustic uroflowmetry. The app-based measurement system allows patients to record voiding data conveniently without additional equipment, such as measuring cups or paper logs. Previous studies have reported higher satisfaction and adherence with app-based systems compared to conventional uroflowmetry, even among older adults unfamiliar with smartphones []. In our cohort, similar usability was observed among participants aged more than 70 years, likely reflecting both the intuitive interface design and the brief in-office education that enhanced confidence and accuracy of use [,]. The automatic generation of an electronic voiding diary may have further increased engagement by reducing manual documentation and simplifying self-tracking.

From a clinical workflow perspective, such usability supports integration of acoustic uroflowmetry into telemedicine and self-management pathways for BPH and postoperative monitoring. Home-based acoustic measurements can be securely transmitted to clinicians for asynchronous review, enabling continuous monitoring of recovery trends and early identification of voiding deterioration without frequent in-person visits. When combined with patient-reported outcomes, such as IPSS, app-based flow metrics may enhance remote clinical decision-making and support personalized treatment adjustments. Integration with electronic medical records and automated alerts based on individualized thresholds could further streamline care within digital urology ecosystems.

Nevertheless, several equity and accessibility considerations should be acknowledged. Smartphone literacy remains a potential barrier, particularly among older or socioeconomically disadvantaged populations. In our study, targeted education and a simplified user interface mitigated many of these challenges, but broader implementation will require interfaces accommodating sensory or cognitive limitations. Cost and device availability also remain relevant, as not all patients may have access to compatible smartphones or stable internet connections, potentially widening digital health disparities. Data privacy and cybersecurity represent additional priorities. Because acoustic recordings and voiding profiles constitute personal health information, strict adherence to encryption, anonymization, and data protection regulations (eg, General Data Protection Regulation and Health Insurance Portability and Accountability Act) is essential. Finally, regulatory approval processes for software as a medical device must be clearly defined to ensure safety, performance, and clinical accountability. Early engagement with regulatory authorities and compliance with international validation frameworks will be crucial for widespread clinical adoption.

Collectively, these findings suggest that app-based uroflowmetry not only provides accurate and reproducible measurements but also aligns with the evolving paradigm of patient-centered, connected urological care. With careful attention to usability, privacy, and equity, such technologies could substantially enhance accessibility to postoperative monitoring and chronic symptom management through scalable digital health integration.

Limitations

This study is not without limitations. First, conventional uroflowmetry was performed at a single session, with repeat measurements conducted only if the patient was unable to void at the first trial or had low VV (≤150 mL), to ensure reliability of the uroflowmetry measurements. However, a single in-office voiding trial may overestimate or underestimate the actual symptoms and change over clinical course, and repeated measurements, as in the mobile uroflowmetry, may be required. Second, no information on TURP clinical variables, such as baseline prostate-specific antigen, resection volume, or pathology, was included in our analysis. While the loss of such information was detrimental to our results, resection percentage as a surrogate for completeness of adenoma resection may have shown a strong correlation with IPSS and Q_max change as estimated from both app-based and in-office measurements, supporting our findings. Moreover, as this study aimed to validate agreement between mobile and in-office uroflowmetry, any such factors would likely have affected both modalities equally and thus are unlikely to alter the comparative findings. Given the exploratory nature of this study, survey questionnaires were custom made and were not validated in a separate study, which may undermine the reliability of the reported outcomes. Limitations associated with the lack of psychometric validation are acknowledged, and future studies should incorporate standardized and validated patient-reported outcome measures to strengthen the assessment of usability. Finally, this study did not include a randomized control group and was conducted in a pilot prospective observational trial setting, limiting the strength of causal inference. However, this design was deliberately chosen to evaluate the feasibility and assess the preliminary performance of the mobile uroflowmetry in a clinical treatment scenario, with the plan of performing larger studies in a randomized and controlled framework to establish the potential replacement of conventional methods. The limited sample size and observational design of this study suggest potential for mobile uroflowmetry; however, they are insufficient to fully support complete replacement of conventional uroflowmetry. Future head-to-head randomized controlled trials comparing long-term outcomes between mobile uroflowmetry and in-office measurements are required to further validate the clinical efficacy of mobile methods. In particular, appropriate methods, such as Bonferroni or false discovery rate correction to address multiple testing and repeated measures, will be required.

Taken together, this study demonstrates the feasibility of using mobile, app-based uroflowmetry as a reliable alternative to conventional in-office measurements. By overcoming the spatial and temporal limitations inherent to traditional uroflowmetry, app-based measurements enable continuous, home-based assessment of postoperative urinary flow dynamics. Unlike previous validation studies limited to healthy or stable populations, our findings extend the applicability of this technology to a postsurgical cohort, showing its potential to capture dynamic recovery patterns and detect functional improvement without requiring frequent outpatient visits. Although no cases of acute retention or early stricture occurred during follow-up, the ability to remotely monitor flow changes suggests a role for early detection of postoperative complications and personalized recovery tracking.

Nonetheless, these findings should be interpreted within the scope of a feasibility study. This work establishes proof of concept and short-term clinical reliability but does not yet address long-term adherence, scalability, or outcome-driven end points. The logical next steps include conducting a randomized controlled trial comparing acoustic and conventional uroflowmetry in diverse clinical settings, followed by broader real-world implementation studies to evaluate cost-effectiveness, user engagement, and system integration within telehealth and electronic medical record platforms. With such validation, app-based uroflowmetry could evolve into a scalable, patient-centered component of precision urological care.

Conclusions

In this prospective pilot observational study, app-based uroflowmetry (proudP) measurements showed reasonable concordance with conventional in-office testing, indicating its feasibility as a tool for perioperative surveillance in BPH surgery. The app-based system effectively reflected both in-office flow values and longitudinal changes in symptom severity, as measured by IPSS, suggesting potential for reliable home-based monitoring of postoperative recovery. Nonetheless, the absence of randomization, the use of a single cohort, and the limited follow-up necessitate caution in interpreting these findings. Future large-scale randomized and real-world implementation studies across diverse populations with lower urinary tract symptoms are warranted to establish the clinical validity, cost-effectiveness, and scalability of app-based uroflowmetry as a practical extension of telemedicine in contemporary urological care.

Introduction

Background

Inflammatory bowel disease (IBD) is a chronic, immune-mediated inflammatory condition of the gastrointestinal tract, comprising ulcerative colitis, Crohn disease, and unclassified types []. The global prevalence of IBD has been rising [], which results in notable economic and health care burdens []. With enhanced diagnostic capabilities and rapid urbanization, the incidence of IBD has significantly risen in China, making it the country with the highest prevalence in Asia []. By 2025, the number of individuals affected by IBD could reach 1.5 million in China []. The highest incidence of IBD is among adolescents and young adults [].

Currently, IBD is a lifelong condition with no definitive cure. Manifestations such as repeated diarrhea, fecal blood, stomach ache, and severe tiredness greatly affect the life quality of adolescents and young adults [], with self-management behaviors being crucial in enhancing life quality and disease prognosis []. Self-management behaviors encompass patient actions aimed at sustaining and enhancing their health via various self-guided actions, covering areas such as medical, emotional, and role management [].

The adolescent and young adult phase represents a critical transition from childhood to adulthood, characterized by substantial physiological and social role transformations []. Young individuals with IBD encounter dual challenges: managing their medical condition while adapting to social role changes []. Consequently, researchers have highlighted that self-management behaviors of adolescents and young adults with IBD need to be improved [-]. Therefore, effective interventions are urgently needed to enhance self-management behaviors in this population.

However, existing interventions for adolescents and young adults with IBD often concentrate on isolated aspects of self-management and demonstrate considerable heterogeneity in results []. Moreover, these interventions [], which are typically led by psychologists, do not align with China’s clinical practice. In China, clinical nurses primarily assume responsibility for patient self-management. Consequently, it is critically important to develop an all-encompassing and effective program for self-management behaviors of adolescents and young adults with IBD, particularly within a nurse-led clinical environment.

The formation and sustainability of self-management behaviors are underpinned by underlying motivational mechanisms. The self-determination theory [] serves as a pivotal framework in behavioral studies, playing a crucial role in predictive model construction and intervention design []. This theory highlights that fulfilling basic psychological needs (competence, autonomy, and relatedness) is indispensable for fostering motivation and sustaining behaviors [].

Based on the self-determination theory, our research team conducted a preliminary study [] on the influencing factors of self-management behaviors in adolescents and young adults with IBD. The study [] revealed that perceived social support would influence self-management behaviors through the mediating effects of basic psychological needs and emotional issues, indicating that enhancing perceived social support, satisfying basic psychological needs, and alleviating emotional issues were crucial for improving self-management behaviors. To identify effective strategies for these improvements, we conducted a systematic review of evidence [] in self-management interventions for this population. The review found that multicomponent interventions were the most effective approach. Health education was necessary to increase knowledge and satisfy the need for competence; peer support could significantly enhance perceived social support and satisfy the need for relatedness; group-based mindfulness training could effectively relieve emotional problems; and remote interventions were shown to improve adherence to intervention among adolescents and young adults. In addition, solution-focused intervention [], which complements self-determination theory by addressing the basic psychological needs [], has been commonly applied in nursing in the form of short-term groups to enhance self-management behaviors among adolescents and young adults [].

Building on our preliminary study [] and systematic review [], we designed a multicomponent intervention program tailored to enhance self-management behaviors in adolescents and young adults with IBD. This program was delivered through short-term remote group sessions and integrated health education, solution-focused intervention, peer support, and mindfulness training to address the basic psychological needs underlying self-management behaviors, thereby promoting the initiation and maintenance of self-management behaviors.

Objectives

This research primarily aimed to evaluate the effectiveness of this intervention program over standard care in fostering self-management behaviors among adolescents and young adults with IBD. The ancillary goals included assessing its effectiveness in improving the perceived social support and basic psychological needs, diminishing levels of anxiety and depression, and lessening disease activity in this group.

Methods

This study was implemented in accordance with the predefined trial protocol [] and was reported according to the CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines [].

Study Design and Setting

Conducted between July 2024 and January 2025, this research entailed a double-center, single-blind, 2-arm randomized controlled trial in gastroenterology units of 2 tertiary hospitals (1 pediatric hospital and 1 general hospital) in Chongqing, China. Chongqing stands as a municipality under direct administration and a central national city in China.

Participants

Inclusion criteria were diagnosis of ulcerative colitis or Crohn disease [], age ranging from 13 to 24 years [], and ability to provide informed consent and express oneself clearly. Exclusion criteria were having severe intellectual impairment; pregnancy; history of cancer or active cancer diagnosis; currently receiving psychiatric medications, therapy, or other psychological intervention; and refusal to participate. Withdrawal criteria were voluntary withdrawal for personal reasons, accompanied by an exit interview to elucidate the reasons for withdrawal; and loss of contact.

Informed Consent and Baseline Assessment

A researcher (DLW) recruited participants from inpatients at the gastroenterology wards of the 2 hospitals in July 2024. Eligible patients were identified by reviewing daily admission lists and approached directly in their wards. The researcher provided a verbal explanation of the study and obtained written informed consent from participants or guardians. For participants younger than 18 years, parental consent was required before obtaining the adolescents’ consent. The recruiting researcher was not involved in the delivery of the intervention.

The baseline assessment was administered via a unique web link to the questionnaire hosted on the Wenjuanxing platform (a Chinese online survey tool compliant with data privacy regulations) within 24-48 hours after obtaining informed consent. Following completion of research ethics and survey administration training, the researchers (JJH and XW) conducted a baseline assessment, which included (1) collection of general information, including age, gender, residence, ethnicity, annual household income, current educational background, main caregiver, disease type and duration, and surgical history; and (2) assessment of outcome variables, as described in “Outcome Assessment” section.

Sample Size

The sample size was calculated using PASS software (version 16.0; NCSS Limited Liability Company), with parameters derived from a related previous study []. Specifically, that study [] reported a mean difference of 10.1 in self-management behavior scores between the 2 comparison groups, with a corresponding pooled SD of 5.54. Setting a significance level (α) of .05 (2-tailed) and a desired statistical power of 0.8 (80%), the initial calculated sample size was 47 participants. After accounting for a projected dropout rate of 19% (9/47), the final minimum sample size was determined to be 56 participants, with no fewer than 28 individuals in each group (intervention group and control group).

Randomization and Blinding

Following enrollment, participants were assigned sequential numbers. A researcher independent of the study team then randomly allocated them to the control and intervention groups at a 1:1 ratio, using random numbers generated by the RAND function in Excel software (Microsoft Corp). To ensure allocation concealment, allocation results were stored in sequentially numbered, sealed envelopes maintained by an independent research assistant external to the research team and opened only at the time of intervention initiation. Participants, the recruiter, outcome evaluators, and the data analyst were blinded to group assignments.

Intervention

Control Group

Routine care was provided to the control group, including face-to-face health education during hospitalization and at discharge, a telephone follow-up within 1 week of discharge, and real-time doctor-patient communication via WeChat (a widely used social media app in China). While not formally standardized across all settings, this communication method aligns with local clinical practices in our region for maintaining postdischarge engagement.

Intervention Group

The intervention group received the remote intervention program in addition to routine care. To develop this program, a stakeholder workshop was organized. For this workshop, 2 adolescents and young adults with IBD (aged 17 years with a 3-year disease history and 21 years with a 5-year disease history, respectively) and 13 health providers (see Table S1 in for details) were invited to discuss and revise the draft program, culminating in the finalization of a multicomponent remote group intervention program. In addition, data on the health care providers’ judgment bases and their familiarity were collected (Tables S2 and S3 in ). Based on these judgment bases and familiarity levels, we further calculated the authority coefficient of the health care providers’ judgments. The specific calculation principles and results are provided in the “Health Care Providers’ Judgments” section of .

The intervention program is detailed in Table S4 in . This program consisted of 9 weekly sessions facilitated through a remote conferencing platform (Tencent Meetings software; Tencent Holdings Limited). This 9-week duration aligned with the semester vacation of Chinese students, which was expected to increase their participation enthusiasm. With the exception of the initial and final weeks, which focused on starting and ending the program, every weekly session comprised these components:

1. Health education: This component covered medication, dietary management, physical exercise, disease monitoring, vaccination, and home care procedures. Its objective was to enhance self-management knowledge and satisfy the need for competence.
2. Solution-focused intervention: This involved goal-setting discussions, exception-seeking questions, scaling questions, miracle questions, and relationship-oriented questions, aiming to comprehensively boost the satisfaction of basic psychological needs.
3. Peer support: Participants engaged in discussions and shared their experiences and insights, fulfilling the need for relatedness. Volunteers from local patient organizations were also invited to share their stories, encouraging and motivating participants to open up.
4. Mindfulness training: This component aimed to relax the emotion and enhance the perception of internal and external resources.

Regulating Quality

To guarantee the effectiveness of the program’s execution within the intervention group, these steps were implemented:

Preparation of Intervention Materials

To aid participants in fully grasping the program, a uniform manual, a tailored canvas bag, and a pen (illustrated in Figure S1 in ) were created and disseminated.

Implementation of the Intervention

The nurse (YFZ) received training from the psychological counselor (YYC). The counselor participated throughout the intervention process to provide quality supervision and guidance.

The intervention adopted a group discussion approach. Using the online conferencing Tencent Meetings software, participants were randomly divided into smaller groups of 2-3 members. After the group discussions, a collective sharing session was held to enhance engagement.

Reinforcement of Intervention Effects

Relevant homework assignments were assigned to reinforce and solidify the effects of the intervention.

After each intervention activity, adolescents were required to complete a feedback scale to rate their satisfaction on a scale of 1-5.

For participants unable to attend sessions in real time, the intervention was documented via video recording of the full group session. Researcher YFZ supervised these participants to ensure that they viewed the recorded videos within 1 week of the session.

Outcome Assessment

Information was gathered by researchers (JJH and XW) through the self-reporting questionnaire on the Wenjuanxing platform, with the exception of disease activity, which underwent external evaluation via the electronic medical record system and phone interviews.

Measurement of the Main Outcome Indicator: Self-Management Behavior

We used the Self-Management Behavior Scale of Inflammatory Bowel Disease, developed by Chinese scholars [], to assess the self-management behaviors of the participants. The scale encompasses 7 dimensions: medication management, dietary practices, disease monitoring, emotional regulation, physical exercise, daily life, and resource utilization, and it comprises 36 items. Responses are gauged on a 5-point scale, ranging from 1 (never) to 5 (always). The Cronbach a coefficient of the scale was 0.945 in the original study and 0.941 in this study. Chinese scholars commonly use this scale to evaluate self-management in patients with IBD [].

Measurement of Secondary Outcome Indicators

Basic Psychological Needs

This study used the Chinese version of the Basic Psychological Needs Satisfaction Scale [], adapted from the original one []. This version contains 9 items and 3 dimensions, namely, autonomy, competence, and relatedness. The rating for each item ranges from 1 (strongly disagree) to 7 (strongly agree). The Cronbach a coefficient of this scale was 0.86 in the original study and 0.941 in this study. This version of this scale has been widely used [].

Perceived Social Support

This study used the Chinese version of the Perceived Social Support Scale [], adapted from the original one []. The scale consists of 12 items divided into 3 dimensions: family support, friend support, and other support, and is assessed on a 7-point scale from 1 (strongly disagree) to 7 (strongly agree). The Cronbach a coefficient of the scale was 0.88 in the original study and 0.943 in this study. This scale has been widely used [].

Anxiety

The Generalized Anxiety Disorder 7-item Scale (GAD-7) was used to assess the severity of anxiety over the past 2 weeks. Comprising 7 elements, this item is evaluated on a scale ranging from 0 (not at all) to 3 (almost daily). The total score of GAD-7 ranges from 0 to 21, with score ranges interpreted as follows: 0-4 points indicate no significant anxiety symptoms, 5-9 points denote mild anxiety symptoms, and a score of ≥10 points indicates the generalized anxiety symptoms []. The Chinese version of the GAD-7 has been widely used in clinical practice []. The Cronbach a coefficient of this scale was 0.937 in this study.

Depression

The Patient Health Questionnaire-9 (PHQ-9) was used to assess the level of depression in the past 2 weeks. It contains 9 items, which are scored on a scale from 0 (not at all) to 3 (almost every day). The total score of the PHQ-9 ranges from 0 to 27, with established interpretive criteria: 0-4 points indicate no significant depressive symptoms, 5-9 points denote mild depressive symptoms, and a score of ≥10 points is indicative of moderate to severe depression symptoms []. The Chinese version of the PHQ-9 is a reliable measure of depressive symptoms in clinical practice []. The Cronbach a coefficient of this scale was 0.920 in this study.

Disease Activity Level

For participants with Crohn disease, the Pediatric Crohn’s Disease Activity Index was applied to those younger than 18 years, while the Crohn’s Disease Activity Index was used for those aged 18 years and older. For participants with ulcerative colitis, the Pediatric Ulcerative Colitis Activity Index was used for those younger than 18 years, and the Simple Clinical Colitis Activity Index was used for those aged 18 years and older. Using these measurements, the severity of disease activity was categorized into remission, mild, moderate, or severe [].

Evaluation Schedule

Outcome indicators of participants were assessed at baseline (T0), immediately after the intervention (T1), and 12 weeks after the intervention (T2). For validity, an interim analysis was conducted at T1: no significant differences in primary or secondary outcomes would have resulted in a decision to stop T2 follow-up; if differences existed, results remained confidential until all data collection was complete (in line with the blinded protocol), with details available in the study protocol [].

Statistical Analysis

Statistical analyses were conducted using SPSS software (version 26.0; IBM Corp). To examine categorical data across 2 groups, either the chi-square test or the Fisher exact test was used, with findings displayed in terms of frequencies and percentages. Normality tests were performed on continuous variables to determine the suitable statistical techniques. Information showing a normal distribution underwent analysis via the t test and was presented as mean (SD). In contrast, data that did not follow a normal distribution were evaluated using the rank sum test and presented as median (IQR).

For normally distributed data assessed at multiple time points within a group, mixed-design analysis of variance was used. Effect sizes were presented as partial eta-squared (η² ). The value of η² ranges from 0 to 1 and can be interpreted as small (η² ≥0.01), medium (η²≥0.06), and large effects (η²≥0.14) []; for non–normally distributed data, the Friedman test was applied, with Bonferroni correction used for post hoc multiple comparisons. The significance level (α) was set at .05. For Bonferroni correction, the adjusted significance threshold was calculated as 0.05 divided by the number of comparisons (n=3), resulting in a corrected statistical significance level of P<.017. Subgroup analyses were not conducted due to the small sample size in this study.

A Little’s Missing Completely At Random test was performed to evaluate the missing mechanism (χ²₁₄=10.82; P=.63), confirming that the data were missing completely at random. Missing data were addressed through multiple imputation methods. The analysis of this study adhered to the principles of intention-to-treat analysis.

Ethical Considerations

Approval for the research was granted by the ethics review boards of the Children’s Hospital of Chongqing Medical University and Chongqing General Hospital (approval numbers: file nos. 2023,395 and KYS2024-008-01). No ethical exemption was applied. Written informed consent was obtained from all participants (with guardians providing consent for those younger than 18 years), and the informed consent forms are available in . No secondary analysis was planned, with ethics approval for no extra consent. Data were deidentified (unique codes) and stored encrypted. No participant compensation was provided. No identifiable images were included; future use requires consent and form uploads.

Result

Overview

Initially, 91 potential participants were identified, with 17 excluded: 2 ineligible for failing to meet the inclusion age, 3 ineligible due to unconfirmed diagnosis, and 12 declining participation for personal reasons. As a result, 74 participants were recruited, with 37 assigned to the intervention group and 37 to the control group. Of the participants, 74 (100%) completed the evaluation at T0; 72 (97.3%) completed the evaluation at T1, with 2 cases of missing data (2.7% missing rate); and 69 (93.2%) completed the evaluation at T2, resulting in 5 cases of missing data (6.8% missing rate). A flow diagram of the study is shown in . No important harms or unintended effects were observed in either group.

In the intervention group, the mean real-time participation rate during the 9 online intervention sessions was 79.52% (95% CI 66.8%-92.2%), while the recorded video-viewing rate was 20.48% (95% CI 8.1%-32.9%). The satisfaction score was mean 4.97 (SD 0.08, 95% CI 4.94-5.00) on a 5-point scale.

Baseline Characteristics

The age of the participants was mean 18.95 (SD 2.96) years. Males constituted 71.62% (53/74) of the sample. displays the sociodemographic details and clinical traits of the participants, revealing no significant difference between the intervention and control groups at baseline.

Effects of the Intervention on the Primary Outcome

As shown in , regarding self-management behaviors, a significant time × group interaction was observed (F_{interaction effect}=8.339; P<.001); between-group comparisons showed no difference at T0 (95% CI –12.728 to 5.539; P=.435, η²=0.008) but significant superiority of the intervention group at T1 (95% CI –24.370 to –8.982; P<.001, η²=0.206) and T2 (95% CI –22.594 to –5.784; P=.001, η²=0.136); and within-group analyses revealed no changes in the control group (P=.16, η²=0.050) but significant differences in the intervention group (P<.001, η²=0.426). For detailed within-group comparisons across different time points, see Table S5 in . The trend of these results is illustrated in A. For the analysis of the scores across various dimensions of self-management behaviors, refer to Table S6 in .

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Effects of the Intervention on Secondary Outcomes

Effects of the Intervention on Perceived Social Support

As shown in , regarding perceived social support, a significant time × group interaction was observed (F_{interaction effect}=3.264; P=.04); between-group comparisons showed no difference at T0 (95% Cl –9.030 to 0.868; P=.105, η²=0.036) but significant superiority of the intervention group at T1 (95% CI –13.932 to –4.068; P=.001, η²=0.155) and T2 (95% CI –11.890 to –1.407; P=.014, η²=0.082); and within-group analyses revealed no changes in the control group (P=.76, η²=0.008) but significant differences in the intervention group (P=.001, η²=0.190). For detailed within-group comparisons across different time points, see Table S5 in . The trend of these results is illustrated in B. For the analysis of the scores across various dimensions of perceived social support, refer to Table S7 in .

Effects of the Intervention on Basic Psychological Needs

As shown in , regarding basic psychological needs, no significant time × group interaction was observed (F_{interaction effect}=1.231; P=.30); between-group comparisons showed no difference at T0 (95% CI –6.173 to 0.930; P=.146, η²=0.029) but significant superiority of the intervention group at T1 (95% CI –8.323 to –1.569; P=.005, η²=0.106) and T2 (95% CI –7.720 to –0.172; P=.04, η²=0.057); and within-group analyses revealed no changes in the control group (P=.98, η²=0.001) but significant differences in the intervention group (P=.049, η²=0.081). For detailed within-group comparisons across different time points, see Table S5 in . The trend of these results is illustrated in C. For the analysis of the scores across various dimensions of basic psychological needs, refer to Table S8 in .

Effects of the Intervention on Anxiety

The Mann-Whitney U test was conducted to compare anxiety scores between the 2 groups at different time points, with the results summarized in . At T0, there was no significant difference detected among the groups (P=.75, z=–0.321). At T1 and T2, the intervention group demonstrated statistically lower scores than the control group (P=.04, z=–2.096; P=.007, z=–2.69). Within-group comparisons revealed that the control group’s anxiety scores exhibited a statistically significant overall difference (P=.007, χ²₂=9.894), with post hoc analysis indicating that the score at T2 was significantly lower than that at T0 (P<.017). For the intervention group, anxiety scores also showed a statistically significant overall difference (P<.001, χ²₂=32.463), with post hoc analysis demonstrating that scores at both T1 and T2 were significantly lower than that at T0 (P<.017). The trend of these results is illustrated in D.

Effects of the Intervention on Depression

The analysis of depression scores is shown in . At T0, the 2 groups showed no significant difference (P=.92, z=–0.098). At T1 and T2, the intervention group demonstrated statistically lower scores than the control group (P=.048, z=–1.981; P=.03, z=–2.115). Within-group comparisons revealed that the control group’s depression scores exhibited a statistically significant overall difference (P=.03, χ²₂=6.764). However, the post hoc analysis showed no statistically significant differences between time points in the control group (P>.017). For the intervention group, depression scores also showed a statistically significant overall difference (P<.001, χ²₂=15.228), with post hoc analysis demonstrating that scores assessed at T1 and T2 were markedly less than that at T0 (P<.017). The trend of these results is illustrated in E.

Effects of the Intervention on Disease Activity

Disease activity between the 2 groups was evaluated using the Mann-Whitney U test, as detailed in . Findings showed negligible variance in disease activity between the groups at T0 and T1 (P=.44, z=–0.769; P=.16, z=–1.403). At T2, a higher percentage of participants in the intervention group experienced remission than those in the control group, showing statistically significant differences (P=.03, z=–2.231).

Discussion

Principal Findings

Self-determination theory has been widely validated for improving self-management behaviors in other populations with chronic diseases [,]. A key innovation of this study was its first application of this theory to adolescents and young adults with IBD, offering a novel theoretical framework for clinical interventions targeting this population. Based on the mechanisms underlying the formation and sustainability of self-management behaviors [], this study developed a remote multicomponent program, integrating health education, solution-focused intervention, peer support, and mindfulness training This intervention program showed significant effects in enhancing self-management behaviors, strengthening perceived social support, and fulfilling basic psychological needs among adolescents and young adults with IBD, while also mitigating their anxiety, depression, and disease activity. Notably, unlike traditional in-person intervention, this remote program could offer greater flexibility. The favorable real-time participation rate and satisfactory feedback score in the intervention group indicated that the program was well received by participants.

Regarding self-management behaviors, the intervention group demonstrated superiority over routine care, highlighting that the intervention program should serve as a valuable and beneficial complement to routine care. Routine care primarily relies on one-way health education. As a complex, multidimensional construct (encompassing disease, emotional, and role management), self-management behaviors cannot be fully improved by routine care’s typical one-way health education []. Critically, most self-management intervention studies have been led by specialized psychotherapists [], rendering them unsuitable for nurse-led clinical settings. Although this study used a multidisciplinary and multicomponent intervention, its overall nurse-led approach could enhance clinical feasibility and offer insights for regions with similar clinical contexts.

In perceived social support, the intervention group exhibited a significant advantage over the control group. This advantage in the intervention group could be plausibly attributed to the intervention’s multicomponent design. Unlike extant literature [] that predominantly used peer support to modulate psychological outcomes in patients with IBD, this study innovatively integrated peer support with solution-focused intervention, transcending passive reciprocal assistance to proactively cultivate participants’ capacity to identify, mobilize, and optimize inherent support resources within their lived contexts.

In addition, this study revealed that the scores of competence and relatedness (2 dimensions of basic psychological needs) in the intervention group were higher than those in the control group at T1 and T2 (see Table S8 in ). However, the autonomy dimension did not achieve significance either within groups or between groups at all time points, as elaborated in Table S8 in . Although theoretical literature [] posited that solution-focused intervention could enhance the satisfaction of basic psychological needs, its practical application should be contextualized within specific cultural backgrounds. Within an Asian cultural context, parental authority and overprotection often hinder the development of adolescents’ autonomy []. Against this cultural backdrop, the autonomy of participants in this study proved challenging to foster in the absence of parental involvement. From the perspective of self-determination theory, this study framed autonomy around attaining self-independence. Notably, the program might not account for adolescents’ potential to view “relying on parents” as an autonomous choice. Future research should thus reframe objectives to explore how adolescents use parental support to meet autonomy needs, rather than solely emphasizing self-independence.

Although the intervention program outperformed routine care in reducing anxiety and depression in the participants, within-group analyses showed that the control group also had significantly lower anxiety scores at T2 than at T0. This finding implied that routine care had a certain positive impact on emotion. Alternatively, it could be inferred that the potential for self-growth among adolescents and young adults with IBD was consistent with other research [] that reported posttraumatic growth trends in this population. This observation corroborated the use of a solution-focused approach, which guided participants to recognize intrinsic resources (inherently present in participants, with the intervention facilitating awareness of personal strengths). Furthermore, this study advanced posttraumatic growth theory from phenomenological description to intervention-based empirical validation in this population, providing an entry point for investigating the mediating mechanisms of the disease-related stress and self-growth pathway.

Finally, there were no significant changes in disease activity levels at T1; however, a significant improvement was observed at T2, providing empirical support for the influence of mental health on disease activity, consistent with “gut-brain axis” theory []. This result suggested that the psychological intervention did not yield immediate disease benefits and sustained engagement was needed to modulate brain-gut cross talk, clinically guiding health care providers and patients to set realistic expectations for long-term adherence. Notably, while other study [] has also reported that adding psychological interventions to routine care effectively alleviates disease activity, these interventions were predominantly led by specialized psychologists. In contrast, the nurse-led model of this study could render gut-brain axis-informed care accessible in regions with limited access to psychologists.

Limitations

However, this study still has some limitations. The long-term effectiveness of this study remains to be further verified, as follow-up was limited to 12 weeks. It is recommended to conduct long-term follow-up to determine whether the intervention effect is sustainable in the long run. Furthermore, the sample in this study mainly consisted of individuals with Crohn disease (65/74, 87.84%), males (53/74, 71.62%), and urban populations (62/74, 83.78%). Although this is in line with the epidemiological characteristics of IBD in China [], the imbalance limits generalizability. Efficacy in subgroups such as rural residents or patients with ulcerative colitis remains untested, as these groups may face unique barriers (eg, limited access to remote resources in rural areas) affecting outcomes. In addition, while the sample size calculation confirmed sufficient statistical power for the primary outcomes, the modest sample size may hinder detection of small but clinically meaningful effects (eg, the autonomy dimension of basic psychological needs).

Conclusions

Based on the self-determination theory, this study developed a short-term, group-based, remote, and multicomponent intervention program, integrating health education, peer support, solution-focused intervention, and mindfulness training. The program demonstrated improvements in self-management behaviors, perceived social support, and basic psychological needs among adolescents and young adults with IBD, while also alleviating their anxiety, depression, and disease activity. Theoretically, this study validated the application of a combination of multiple intervention components under the guidance of self-determination theory in adolescents and young adults with IBD. Practically, it was shown that the nurse-led remote intervention was feasible and accessible. Future research should verify the program’s long-term effectiveness and expand to more balanced samples to enhance generalizability; optimizing the intervention to address unmet autonomy needs could further boost its clinical use.

• SoFI’s stock is down Friday afternoon after announcing a share sale.

• The company’s stock is still riding high after beating analysts earnings expectations for seven of the last eight quarters.

SoFi’s been on a winning streak. Today’s it’s taking a breather.

Shares of SoFi Technologies (SOFI), a fintech-turned-bank, are taking a hit after a $1.5 billion share sale announcement on Thursday caught investors and analysts off guard. The most recent capital raise was its second in six months. Still, its stock remains aloft, nearly doubling so far this year.

The company has been riding high on its achievements over the last two years, with seven of its last eight quarterly reports beating analyst earnings expectations, according to Visible Alpha. And the company plans to invest in its existing businesses, relaunch crypto trading, and expand its product offerings—good reasons to have cash on hand.

SoFi plans to expand its offerings in the coming year. That could boost its stck, but the shares have rallied for much of 2025, sitting near all-time highs, and have recently slid after the company announced a share sale to raise capital. Some analysts believe the fintech could qualify for S&P 500 membership, which could also give the shares a lift.

SoFi’s second capital raise in two quarters wasn’t widely expected. Keefe, Bruyette & Woods analyst Tim Switzer said in a recent note that he was “a little surprised” since the latest share sale followed another of the same amount in July. That said, the firm’s capital levels are low compared to bank peers, according to Switzer.

“We believe the raise is largely opportunistic given the stock is near all-time highs,” Switzer wrote yesterday.

The company priced the shares at $27.50 apiece, just a touch below their November all-time high of around $32. Visible Alpha’s Street consensus target is just under $26, perhaps an indication that the company managed a good price—though the Street’s outlook on the shares, based on ratings, is broadly neutral. The shares closed 6% lower, at $27.78.

SoFi started out as a fintech company primarily offering student loan refinancing, but has since transformed into a full-service bank offering bank accounts, personal loans and investment products. It also relaunched a crypto trading platform last month after pausing that service in 2023 as it was securing its national bank charter. SoFi plans to launch its own branded stablecoin next year, according to the company.

KARACHI  –  The State Bank of Pakistan (SBP) injected Rs2,610.8 billion through Reverse Repo Purchase and Shariah Compliant Mudarabah based Open Market Operations (OMO) on Friday to maintain liquidity in the market.  The central bank conducted the Open Market Operation, Reverse Repo Purchase (Injection) for 7 and 14-day tenors on December 05, 2025, and injected Rs2,437.8 billion against 14 bids while other Rs173 billion were inserted through Shariah Compliant Mudarabah based OMO. The central bank received 11 bids for the 14-day Reverse Repo Purchase, cumulatively offering Rs2,384.8 billion at the rate of return ranging between 11.01 to 11.08 percent.

The SBP accepted all the bids with the entire amount at 11.01 percent rate of return. 

Moreover, the SBP also received 3 quotes for the 7-day tenor, cumulatively offering Rs53 billion at the rate of return ranging between 11.03 percent to 11.05 percent. 

The SBP accepted the entire amount at 11.03 percent rate of return. 

Meanwhile, SBP also conducted Shariah Compliant Mudarabah based Open Market Operation for the 7 and 14-day tenors. The central bank did not receive any bid for the 14-day tenor while 3 quotes were received for 7-day tenor offering Rs218 billion at rate of return ranging between 11.01 to 11.06 percent. SBP accepted Rs173 billion against two bids at 11.05 percent rate of return.

TikTok and other social media platforms are hosting AI-generated deepfake videos of doctors whose words have been manipulated to help sell supplements and spread health misinformation.

The factchecking organisation Full Fact has uncovered hundreds of such videos featuring impersonated versions of doctors and influencers directing viewers to Wellness Nest, a US-based supplements firm.

All the deepfakes involve real footage of a health expert taken from the internet. However, the pictures and audio have been reworked so that the speakers are encouraging women going through menopause to buy products such as probiotics and Himalayan shilajit from the company’s website.

The revelations have prompted calls for social media giants to be much more careful about hosting AI-generated content and quicker to remove content that distorts prominent people’s views.

“This is certainly a sinister and worrying new tactic,” said Leo Benedictus, the factchecker who undertook the investigation, which Full Fact published on Friday.

He added that the creators of deepfake health videos deploy AI so that “someone well-respected or with a big audience appears to be endorsing these supplements to treat a range of ailments”.

Prof David Taylor-Robinson, an expert in health inequalities at Liverpool University, is among those whose image has been manipulated. In August, he was shocked to find that TikTok was hosting 14 doctored videos purporting to show him recommending products with unproven benefits.

Though Taylor-Robinson is a specialist in children’s health, in one video the cloned version of him was talking about an alleged menopause side-effect called “thermometer leg”.

The fake Taylor-Robinson recommended that women in menopause should visit a website called Wellness Nest and buy what it called a natural probiotic featuring “10 science-backed plant extracts, including turmeric, black cohosh, Dim [diindolylmethane] and moringa, specifically chosen to tackle menopausal symptoms”.

Female colleagues “often report deeper sleep, fewer hot flushes and brighter mornings within weeks”, the deepfake doctor added.

The real Taylor-Robinson discovered that his likeness was being used only when a colleague alerted him. “It was really confusing to begin with – all quite surreal,” he said. “My kids thought it was hilarious.

“I didn’t feel desperately violated, but I did become more and more irritated at the idea of people selling products off the back of my work and the health misinformation involved.”

The footage of Taylor-Robinson used to make the deepfake videos came from a talk on vaccination he gave at a Public Health England (PHE) conference in 2017 and a parliamentary hearing on child poverty at which he gave evidence in May this year. In one misleading video, he was depicted swearing and making misogynistic comments while discussing menopause.

TikTok took down the videos six weeks after Taylor-Robinson complained. “Initially, they said some of the videos violated their guidelines but some were fine. That was absurd – and weird – because I was in all of them and they were all deepfakes. It was a faff to get them taken down,” he said.

Full Fact found that TikTok was also carrying eight deepfakes featuring doctored statements by Duncan Selbie, the former chief executive of PHE. Like Taylor-Robinson, he was falsely shown talking about menopause, using video taken from the same 2017 event where Taylor-Robinson spoke.

One, also about “thermometer leg”, was “an amazing imitation”, Selbie said. “It’s a complete fake from beginning to end. It wasn’t funny in the sense that people pay attention to these things.”

Full Fact also found similar deepfakes on X, Facebook and YouTube, all linked to Wellness Nest or a linked British outlet called Wellness Nest UK. It has posted apparent deepfakes of high-profile doctors such as Prof Tim Spector and another diet expert, the late Dr Michael Mosley.

Wellness Nest told Full Fact that deepfake videos encouraging people to visit the firm’s website were “100% unaffiliated” with its business. It said it had “never used AI-generated content”, but “cannot control or monitor affiliates around the world”.

Helen Morgan, the Liberal Democrat health spokesperson, said: “From fake doctors to bots that encourage suicide, AI is being used to prey on innocent people and exploit the widening cracks in our health system.

“Liberal Democrats are calling for AI deepfakes posing as medical professionals to be stamped out, with clinically approved tools strongly promoted so we can fill the vacuum.

“If these were individuals fraudulently pretending to be doctors they would face criminal prosecution. Why is the digital equivalent being tolerated?

“Where someone seeks health advice from an AI bot they should be automatically referred to NHS support so they can get the diagnosis and treatment they actually need, with criminal liability for those profiting from medical disinformation.”

A TikTok spokesperson said: “We have removed this content [relating to Taylor-Robinson and Selbie] for breaking our rules against harmful misinformation and behaviours that seek to mislead our community, such as impersonation.

“Harmfully misleading AI-generated content is an industry-wide challenge, and we continue to invest in new ways to detect and remove content that violates our community guidelines.”

The Department of Health and Social Care was approached for comment.

In cancer medicine, the next wave of breakthroughs often appears long before regulatory approval. These investigational therapies generate momentum at major scientific meetings, shift treatment expectations, and signal where oncology is heading. The goal is not hype, but anticipation—because patients, clinicians, and researchers want to understand which emerging medicines are already demonstrating strong efficacy, meaningful survival gains, or first-in-class mechanisms. What they share is simple: their early data suggest they are capable of reshaping treatment standards in the near future.

Last year, many of the therapies highlighted by the OncoDaily Research & Intelligence team went on to receive FDA approval in 2025, while others continue to progress toward regulatory decisions. This year, we again reviewed the latest data, and the OncoDaily Research & Intelligence Editorial Team has selected the 10 most promising cancer drugs not yet approved—agents showing meaningful survival gains, impressive response rates, and first-in-class mechanisms in some of the most difficult cancers to treat.

Most Promising Cancer Drugs 2024

10 most promising cancer drugs not yet approved in 2025

1.⁠ ⁠Vepdegestrant (ARV-471)
2.⁠ ⁠Darovasertib
3.⁠ ⁠Relacorilant
4.⁠ ⁠Daraxonrasib
5.⁠ ⁠Zanzalintinib
6.⁠ ⁠GSK5764227 (HS-20093)
7.⁠ ⁠Anbenitamab (KN026)
8.⁠ ⁠AgenT-797 (iNKT) .
9.⁠ ⁠Pasritamig (JNJ-78278343)
10.⁠ ⁠Iza-Bren (EGFRxHER3 ADC)

These programs are shaping the next wave of innovation and offering a clear preview of what may redefine oncology care in the near future.

1. Vepdegestrant (ARV-471): Rewriting Endocrine Therapy for ER-Positive Breast Cancer

Indication: ER+/HER2- Advanced or Metastatic Breast Cancer (specifically ESR1-mutated).

Mechanism of Action: An oral PROTAC (PROteolysis TArgeting Chimera) protein degrader. Unlike standard inhibitors that block the receptor, Vepdegestrant binds to the estrogen receptor (ER) and triggers the cell’s own machinery to degrade and destroy it.

Key Trial: VERITAC-2 (Phase 3).

Main Results:

• PFS Benefit in ESR1-Mutant Disease: Median PFS 5.0 vs 2.1 months vs fulvestrant (HR 0.58, P<0.001); ORR 18.6% vs 4.0%.
• Overall Population: Median PFS 3.8 vs 3.6 months (HR 0.83; P=0.07), showing strongest activity in ESR1-mutant tumors.
• Safety: Mostly grade 1–2 events; grade ≥3 AEs 23%; low discontinuation (2.9%); manageable fatigue, mild LFT elevations, and low-grade QTc prolongation.

Developer: Arvinas / Pfizer

Vepdegestrant, is an oral PROTAC estrogen receptor degrader designed to go a step beyond traditional endocrine therapy. Instead of just blocking the estrogen receptor like fulvestrant or SERDs, it recruits an E3 ligase and sends the receptor to the proteasome for destruction. The Phase 3 VERITAC-2 trial, published in The New England Journal of Medicine in May 2025, tested Vepdegestrant against fulvestrant in 624 patients with ER-positive, HER2-negative advanced breast cancer who had already received a CDK4/6 inhibitor plus endocrine therapy.

Figure From NEJM Article: Progression-free Survival as Assessed by Blinded Independent Central Review.

The clearest win was in the ESR1-mutated subgroup, which is exactly where resistance to prior endocrine therapy is most common. In these patients (about 43% of the trial), median progression-free survival was 5.0 months with Vepdegestrant versus 2.1 months with fulvestrant (hazard ratio 0.58; P<0.001), and the objective response rate jumped to 18.6% vs 4.0%. In the overall population, the difference was more modest and did not reach formal statistical significance (3.8 vs 3.6 months; HR 0.83; P=0.07), reinforcing the idea that this drug is particularly powerful in ESR1-driven disease rather than all comers.

Safety looked manageable and very “everyday clinic” for an oral endocrine agent. Most adverse events were grade 1–2; grade ≥3 events occurred in about 23% on Vepdegestrant vs 18% on fulvestrant, with low discontinuation rates (2.9% vs 0.7%). Fatigue, mild liver enzyme elevations and occasional QTc prolongation were seen but serious cardiac events were not reported, and gastrointestinal toxicity (nausea, vomiting, diarrhea) was less frequent than what has been observed with some oral SERDs.

Taken together, VERITAC-2 positions Vepdegestrant as a first-in-class PROTAC endocrine therapy with a clear niche in ESR1-mutant, ER+/HER2– advanced breast cancer. With the NDA accepted in August 2025 and a PDUFA date of June 5, 2026, it is one of the most likely near-term approvals to genuinely shift second-line endocrine practice from injections to an oral, mutation-focused degrader.

2. Darovasertib: A Vision-Saving Therapy for Uveal Melanoma

Indication: Uveal Melanoma (Neoadjuvant and Metastatic).

Mechanism of Action: A selective PKC (Protein Kinase C) inhibitor. PKC is a key driver in the GNAQ/GNA11 mutations found in approximately 90% of uveal melanoma cases.

Key Trial: Phase 2 OptimUM-09 trial

Main Results:

• Tumor Shrinkage & Eye Preservation: 83% had tumor shrinkage; ≥20% shrinkage in 54%, enabling 57% eye preservation, rising to 95% in those with ≥20% shrinkage.
• Vision Protection: 70% of plaque brachytherapy candidates had reduced predicted radiation dose, and 65% showed lower predicted risk of severe long-term vision loss; over half improved visual acuity during treatment.
• Safety & Regulatory: Generally well tolerated (grade ≥3 TRAEs 16.8%); granted FDA Breakthrough Therapy Designation as the first systemic neoadjuvant therapy with proven potential to prevent enucleation.

Developer:IDEAYA Biosciences

Darovasertib, developed by IDEAYA Biosciences in collaboration with Servier, is a potent, selective inhibitor of PKC, and is one of the most important new drugs in ocular oncology. Primary uveal melanoma is one of the few solid tumors where patients still routinely face the prospect of enucleation—surgical removal of the eye—or high-dose plaque brachytherapy that often results in major vision loss. With no approved systemic therapy for the localized disease setting, Darovasertib’s neoadjuvant strategy represents a genuine paradigm shift.

Presented at ESMO 2025 in a Proffered Paper session, the Phase 2 OptimUM-09 trial delivered some of the strongest functional-preservation data ever reported in this cancer. Across 94 evaluable patients, 83% experienced measurable tumor shrinkage and 54% achieved ≥20% shrinkage. Among patients originally recommended for enucleation, the therapy preserved the eye in 57%, and in those with ≥20% shrinkage prior to local therapy, the eye-preservation rate soared to 95%. This is unprecedented in a disease where surgical removal is often the only option.

The benefits extended beyond tumor control. In patients eligible for plaque brachytherapy, Darovasertib reduced the predicted radiation dose to critical eye structures in 70%, with two-thirds experiencing a lower predicted risk of severe vision loss at three years. Importantly, more than half of patients across both cohorts improved their visual acuity during neoadjuvant treatment—gaining an average of 17 letters (enucleation cohort) and 10 letters (brachytherapy cohort), a clinically meaningful restoration of functional vision.

Read More About Ocular Melanoma on Oncodaily

These findings, combined with a manageable safety profile—grade ≥3 treatment-related events occurred in 16.8%, with low discontinuation rates—led the FDA to grant Breakthrough Therapy Designation for Darovasertib in the neoadjuvant treatment of primary uveal melanoma. No other systemic therapy has ever demonstrated this degree of tumor control, eye preservation, and functional vision benefit in this population.

With the registrational Phase 3 OptimUM-10 trial now underway and pivotal progression-free survival data from the metastatic UM program expected in late 2025 or early 2026, Darovasertib stands out as a likely first-in-class therapy capable of redefining how uveal melanoma is treated—shifting care from organ removal to organ preservation.

3. Relacorilant: A New Option for Platinum-Resistant Ovarian Cancer

Indication: Platinum-Resistant Ovarian Cancer (PROC).
Mechanism of Action: A selective Glucocorticoid Receptor (GR) Antagonist that blocks cortisol-mediated chemotherapy resistance and restores tumor susceptibility to apoptosis.
Key Trial: ROSELLA (Phase 3).

Main Results (Updated ESMO 2025 LBA45 Data):

• PFS & OS Benefit: Relacorilant + nab-paclitaxel achieved PFS HR 0.70 (median 6.54 vs 5.52 mo) and an OS HR 0.69 with median 15.97 vs 11.50 mo.
• Strong PARPi Subgroup Activity: In PARP inhibitor–exposed patients, median PFS reached 7.36 months (HR 0.60) and 7.36 months in PARPi-progressors (HR 0.56).
• Favorable Safety: Grade ≥3 and serious AEs in PARPi patients were comparable to overall ITT (71% vs 74%; 32% vs 35%), with no new safety signals.

Developer: Corcept Therapeutics.

Relacorilant is a selective glucocorticoid receptor antagonist designed to counteract cortisol-driven chemotherapy resistance—a mechanism long recognized in ovarian cancer biology but never effectively targeted. By blocking GR signaling, relacorilant enhances taxane-induced apoptosis, directly addressing a key driver of platinum-resistant ovarian cancer (PROC), where therapeutic progress has been slow for over a decade.

At ESMO 2025, the Phase 3 ROSELLA trial (LBA45) delivered evidence supporting this approach. Adding relacorilant to weekly nab-paclitaxel produced a 30% reduction in the risk of progression (HR 0.70) and a 31% reduction in the risk of death (HR 0.69), with median OS improving from 11.50 to 15.97 months. This marks the first regimen to improve both PFS and OS over weekly taxane therapy in PROC.

Presented by Domenica Lorusso at ESMO 2025 Congress

A key highlight of the updated analysis involved patients previously treated with PARP inhibitors—a subgroup known for markedly poor outcomes after PARPi progression. ROSELLA demonstrated that relacorilant can partially reverse this resistance biology. Median PFS in PARPi-exposed patients reached 7.36 months, with hazard ratios of 0.60 (prior PARPi) and 0.56 (progressed during PARPi therapy). These results compare favorably with benchmark data such as PAOLA-1, where post-PARPi patients typically show significantly shorter benefit from subsequent chemotherapy.

Critically, relacorilant achieved these improvements without adding toxicity. Safety remained consistent with nab-paclitaxel monotherapy, with no new adverse events and similar rates of grade ≥3 and serious AEs, even in the PARPi subgroup. This distinguishes relacorilant as a rare agent that meaningfully increases chemotherapy effectiveness without compromising tolerability.

Based on the strength of the ROSELLA findings, Corcept is expanding the Phase 2 BELLA program to evaluate relacorilant-containing regimens in platinum-resistant ovarian cancer, platinum-sensitive PARPi-progressors, and endometrial cancer. This expansion reflects growing confidence that GR antagonism may have broader relevance across gynecologic oncology.

With the FDA’s acceptance of the New Drug Application for PROC and a PDUFA date of July 11, 2026, relacorilant is positioned to become the first therapy to deliver dual survival improvements in this setting—and potentially the most meaningful advance in platinum-resistant ovarian cancer management in many years.

4. Daraxonrasib (RMC-6236): The First Real Pan-RAS Inhibitor

Indication: Pancreatic Cancer (and other RAS-mutated solid tumors).

Mechanism of Action: A Pan-RAS Inhibitor (RAS(ON) multi-selective inhibitor). It targets the active form of all three major RAS variants (KRAS, NRAS, HRAS), addressing a mutation historically considered “undruggable.”

Key Trial: RASolute 303 (Phase 3) and Phase 1/2 updates.

Main Results:

• High activity in PDAC: ORR 47% with monotherapy and 55% with daraxonrasib + GnP in first-line metastatic PDAC; DCR ~90%.
• Durable benefit in 2L+: ORR 29–35%, median PFS ~8 months, median OS 13–16 months, with >90% disease control.
• Favorable safety: Mostly rash and mild GI events; no treatment discontinuations due to toxicity; dose intensity >80%.

Developer: Revolution Medicines

Daraxonrasib (RMC-6236),  represents one of the most advanced efforts to target RAS—often described as the most difficult oncogenic driver in solid tumors. Unlike mutation-specific drugs such as KRAS G12C inhibitors, daraxonrasib is a multi-selective RAS(ON) inhibitor, designed to suppress a broad spectrum of pathogenic RAS variants including G12X, G13X, and Q61X, which together drive the overwhelming majority of pancreatic ductal adenocarcinomas (PDAC).

Pancreatic cancer remains a malignancy with extremely poor survival outcomes, where median survival in the metastatic setting is measured in months and chemotherapy remains the only systemic standard. Against this backdrop, the breadth and consistency of daraxonrasib’s activity in 2025 generated significant clinical optimism.

In the second-line metastatic PDAC cohort, long-term follow-up showed durable activity rarely seen in this setting. At the 300 mg daily dose, daraxonrasib achieved ORR 29–35%, disease-control rates over 90%, and median PFS of 8.1–8.5 months. Median OS reached 13.1–15.6 months, with a median follow-up of approximately 17 months. The safety profile remained manageable: rash and mucositis/stomatitis were the most common toxicities, grade ≥3 events occurred in about one-third of patients, and importantly, no patients discontinued therapy due to toxicity, with dose intensity maintained at 86%.

Early first-line metastatic PDAC data further strengthened the signal. Daraxonrasib monotherapy yielded a 47% response rate, and the combination of daraxonrasib with gemcitabine/nab-paclitaxel delivered an ORR of 55%, with ~90% disease control and no unexpected safety concerns. Mean dose intensity remained above 80%, indicating good tolerability even in combination regimens. These response levels exceed historical expectations for first-line chemotherapy in PDAC and suggest that RAS-directed therapy may be viable even in untreated disease.

These findings support the ongoing RASolute 303 Phase 3 trial, which is enrolling first-line metastatic PDAC patients into three arms—daraxonrasib monotherapy, daraxonrasib + GnP, and GnP alone—with PFS and OS as dual primary endpoints. In parallel, the RASolute 302 Phase 3 trial is evaluating daraxonrasib monotherapy in second-line PDAC, and an additional Phase 3 study is planned in the adjuvant setting.

In October 2025, the FDA granted Orphan Drug Designation to daraxonrasib for pancreatic cancer, reflecting both the severity of the disease and the strength of emerging clinical evidence.

If the ongoing Phase 3 trials confirm the activity seen in early studies, daraxonrasib could become the first broadly active RAS inhibitor for pancreatic cancer—potentially redefining the therapeutic landscape of a disease historically dominated by cytotoxic therapy alone.

Read More About RASolute Trial on OncoDaily GI

Zanzalintinib: A New Potetial Standard of Care for Advanced Colorectal Cancer?

Indication: Refractory Colorectal Cancer (CRC).

Mechanism of Action: A next-generation Multi-kinase Inhibitor targeting VEGFR, MET, and the TAM family kinases (Tyro3, Axl, Mer), which are involved in tumor growth and immune evasion.

Key Trial: STELLAR-303 (Phase 3).

Main Results:

• OS Benefit: Median OS 10.9 vs 9.4 months vs regorafenib (HR 0.80, p=0.0045) in refractory MSS metastatic colorectal cancer.
• PFS Benefit: Median PFS 3.7 vs 2.0 months (HR 0.68), with consistent benefit across all subgroups—including patients with or without liver metastases.
• Manageable Safety: Grade 3/4 TRAEs in 59%, mainly hypertension (15%), fatigue (6%), diarrhea (6%), and proteinuria (6%); no new safety signals.

Presented by Anwaar Saeed at ESMO 2025 Congress

The phase III STELLAR-303 trial delivered the first randomized evidence that a multitargeted tyrosine kinase inhibitor combined with immunotherapy can extend survival in microsatellite-stable metastatic colorectal cancer (MSS mCRC), a population historically resistant to checkpoint inhibition. In this global study of 901 previously treated patients, zanzalintinib plus atezolizumab achieved a statistically significant improvement in overall survival compared with regorafenib, the current standard of care. Median OS reached 10.9 months with the combination versus 9.4 monthswith regorafenib (HR 0.80; p=0.0045), and this advantage was consistent across all predefined subgroups, including patients with the traditionally immune-refractory profile of active liver metastases.

Progression-free survival also favored the combination, with a median PFS of 3.7 months compared with 2.0 months for regorafenib (HR 0.68). Although the absolute magnitude of benefit was modest, the findings remain clinically meaningful in the highly refractory MSS setting. Importantly, the safety profile aligned with the known effects of VEGF/MET/TAM pathway inhibition. Grade 3–4 treatment-related toxicities occurred in 59% of patients receiving the combination, most commonly hypertension, diarrhea, fatigue, and proteinuria, but no new or unexpected safety signals emerged.

Read More About STELLAR-303 Trial on OncoDaily

Overall, STELLAR-303 positions zanzalintinib plus atezolizumab as a potential new therapeutic approach for patients with refractory MSS mCRC, supporting further biomarker-driven evaluation and ongoing final OS analyses in patients without liver metastases.

6. GSK5764227 (HS-20093): A Long-Awaited Breakthrough B7-H3 ADC for Sarcomas

Indication: Relapsed/Refractory Osteosarcoma and Soft Tissue Sarcoma (STS).

Mechanism of Action: A B7-H3–targeted antibody-drug conjugate (ADC) carrying a topoisomerase I inhibitor payload.

Key Trial: ARTEMIS-001 (Phase 1/2).

Main Results:

• Osteosarcoma: ORR 20%, DCR 86% in heavily pretreated disease (historical ORR <5% with chemotherapy).
• Soft Tissue Sarcoma: ORR 23%, DCR 92%, with responses across multiple STS subtypes.
• Safety: Manageable toxicity profile with no unexpected safety signals; consistent with topo-I ADC class.

Developer:

GSK5764227 (formerly HS-20093) is a first-in-class B7-H3–directed antibody–drug conjugate (ADC) incorporating a topoisomerase I inhibitor payload, designed to target B7-H3–expressing solid tumors. B7-H3 is highly expressed in osteosarcoma and multiple soft tissue sarcoma (STS) subtypes, making it an attractive therapeutic target in diseases with extremely limited systemic therapy responsiveness. Following GSK’s acquisition of Hansoh Bio’s ADC platform, GSK5764227 has advanced into global development as a next-generation cytotoxic ADC for sarcomas.

Updated results from the ARTEMIS-001 Phase 1/2 study were presented at ESMO 2025 and demonstrated clinically meaningful activity in heavily pretreated sarcoma populations. In relapsed/refractory osteosarcoma, GSK5764227 achieved an Objective Response Rate (ORR) of 20% and Disease Control Rate (DCR) of 86%, markedly exceeding the historical ORR of <5% associated with salvage chemotherapy. In the soft tissue sarcoma cohort, ORR reached 23%with a DCR of 92%, with responses observed across multiple sarcoma subtypes.

The safety profile was consistent with topoisomerase-based ADCs; treatment-related adverse events were manageable, and no new safety signals emerged. Importantly, the drug demonstrated durable tumor shrinkage and disease stabilization in a population with few alternative treatment options and poor prognoses.

Collectively, the ARTEMIS-001 data position GSK5764227 as a potentially transformative therapeutic candidate in bone and soft tissue sarcomas, offering one of the most substantial improvements in response rates seen in this disease area in years. Expansion into later-phase studies is anticipated.

7. Anbenitamab (KN026): A Next-Generation HER2 Bispecific Antibody

Indication: HER2-Positive Gastric Cancer (GC) and GEJ

Mechanism of Action: A bispecific HER2 antibody binding two non-overlapping HER2 epitopes (ECD2 + ECD4), enhancing HER2 blockade, receptor internalization, and ADCC.

Key Trial: KC-WISE (KN026-001, Phase 3).

Main Results:

• PFS Benefit: Median PFS 7.1 vs 2.7 months vs chemotherapy (HR 0.25, p=5.44×10⁻¹²), representing a 75% reduction in risk of progression or death.
• OS Benefit: Median OS 19.6 vs 11.5 months (HR 0.29, p=1.56×10⁻⁶), a 71% reduction in risk of death; OS not yet mature.
• High Response Rates: ORR 55.8% vs 10.8%; DCR 80% vs 41.9%; median DoR 8.2 vs 2.9 months.
• Manageable Safety: Grade ≥3 TEAEs 60.6%, primarily neutropenia, leukopenia, anemia, diarrhea, and asthenia; low cardiotoxicity (3.2%), comparable to control.

Developer: Alphamab Oncology

The first interim analysis of the Phase III KC-WISE (KN026-001) trial presented at the ESMO Congress 2025 demonstrated that anbenitamab (KN026) combined with chemotherapy provides a significant and clinically meaningful benefit in previously treated HER2-positive gastric and gastroesophageal junction (GC/GEJ) cancers after progression on trastuzumab-containing regimens.

In this randomized, double-arm study, patients with HER2-positive GC/GEJ who experienced disease progression following trastuzumab-based therapy were assigned to receive anbenitamab + chemotherapy or placebo + chemotherapy. Baseline characteristics were well-balanced, with most patients presenting with ECOG PS 1 and stage IVB disease. The median follow-up was approximately 9.7 months in both arms.

Presented By Jianming Xu, ESMO 2025

Treatment with anbenitamab yielded a statistically significant improvement in progression-free survival (PFS) compared with chemotherapy alone. Median PFS was 7.1 months in the anbenitamab arm versus 2.7 months in the control arm, corresponding to a hazard ratio (HR) of 0.25 (P = 5.44 × 10⁻¹²), indicating a 75% reduction in risk of disease progression or death. Overall survival (OS) also favored anbenitamab, with a median OS of 19.6 months (not yet mature) versus 11.5 months in the control arm, representing an HR of 0.29 (P = 1.56 × 10⁻⁶) and a 71% reduction in risk of death. Both primary endpoints of the trial—PFS and OS—were met with high statistical robustness.

Objective response outcomes were similarly improved. The ORR was 55.8% with anbenitamab compared with 10.8% in the control group, and the disease control rate (DCR) reached 80.0% vs. 41.9%, respectively. The median duration of response (DoR) was 8.2 months for anbenitamab versus 2.9 months for control therapy, indicating more durable benefit.

Safety findings showed that anbenitamab plus chemotherapy was tolerable and consistent with expected HER2-directed therapy toxicities. Grade ≥3 TEAEs occurred in 60.6% of patients receiving anbenitamab versus 51.6% in the control group, with neutropenia, leukopenia, anemia, diarrhea, and asthenia being the most common high-grade events. Importantly, cardiotoxicity was low (3.2%) and comparable between arms, despite the HER2-targeting mechanism.

Presented By Jianming Xu, ESMO 2025

These interim data indicate that anbenitamab significantly improves PFS, OS, ORR, and durability of response in trastuzumab-pretreated HER2-positive GC/GEJ, positioning it as a strong potential contender for second-line and later-line therapy. The magnitude of benefit compares favorably with results from DESTINY-Gastric04 (trastuzumab deruxtecan), suggesting possible efficacy and safety advantages. Based on these findings, additional trials are planned to expand anbenitamab development into first-line and perioperative settings.

8. iNKT Cell Therapy: An “Off-the-shelf” cell therapy with Transformative Potential

Indication: Refractory Solid Tumors (specifically Metastatic Germ Cell Tumors and Gastric Cancer).

Mechanism of Action: An allogeneic, “off-the-shelf” invariant Natural Killer T (iNKT) cell therapy. It targets CD1d (a lipid-presenting molecule on tumor cells) to trigger a dual attack: direct tumor lysis via perforin/granzyme and rapid modulation of the suppressive tumor microenvironment through the release of cytokines (like IFN-gamma) to recruit host immune cells.

Key Trial: Phase I Trial in Patients With Relapsed/ Refractory Solid Tumors

Main Results:

• Germ Cell Tumor Breakthrough: Achieved a confirmed Complete Remission (CR) in a patient with metastatic disease refractory to 7 prior lines of therapy (including high-dose chemotherapy and stem cell transplant), as published in Oncogene (July 2025).
• Gastric Cancer Activity: Demonstrated a Disease Control Rate (DCR) of ~70% in heavily pre-treated gastric cancer patients, showing efficacy in tumors typically resistant to standard checkpoint inhibitors.
• Safety Profile: Highly tolerable with no Graft-versus-Host Disease (GvHD) or severe neurotoxicity observed, validating its potential as a scalable therapy that does not require HLA matching.

Updated Phase 1 data presented at SITC 2025 highlight agenT-797 as one of the most promising entrants in next-generation, off-the-shelf cell therapy. In patients with PD-1–refractory, heavily pretreated solid tumors, the combination of agenT-797 with anti-PD-1 produced durable and meaningful clinical benefit, with a median overall survival approaching 23 months—a striking result in a population with historically poor outcomes. Several patients achieved deep, long-lasting remissions, including a complete and sustained response beyond two years in metastatic germ-cell/testicular cancer, and prolonged disease control in gastric cancer, thymoma, cholangiocarcinoma, renal cancer, and adenoid cystic carcinoma.

Presented by Ben Garmezy, at SITC 2025

Mechanistic analyses reveal why: agenT-797 functions not only through direct cytotoxicity but through immune re-orchestration, activating dendritic cells, reversing macrophage suppression, rescuing exhausted T cells, and enhancing CD8⁺ and NK-cell infiltration into tumors. The therapy maintained an exceptionally clean safety profile, with no dose-limiting toxicities, no high-grade CRS, and no neurotoxicity, underscoring its suitability for combination regimens and repeat dosing.

Read More About iNKT on OncoDaily IO

Together, these findings position agenT-797 as a first-in-class allo-iNKT cell therapy capable of restoring immune responsiveness in checkpoint-resistant solid tumors and advancing a new therapeutic paradigm for immune-cold cancers.

9. Pasritamig (JNJ-78278343): A New Bispecific Weapon in Prostate Cancer

Indication: Metastatic Castration-Resistant Prostate Cancer (mCRPC).

Mechanism of Action: A first-in-class Bispecific T-cell Engager (BiTE) targeting Human Kallikrein-related Peptidase 2 (KLK2).

Key Trial: Phase 1 First-in-Human Study (NCT04898634).

Main Results:

• PSA Response: In the Recommended Phase 2 Dose (RP2D) group, 42.4% of patients achieved a PSA50 response (≥50% reduction in PSA levels). This occurred even in patients who had failed prior potent androgen receptor inhibitors and taxane chemotherapy.
• PFS Benefit: The median Radiographic Progression-Free Survival (rPFS) was 7.9 months (95% CI 2.9–NE).
• Manageable Safety: Low CRS: Cytokine Release Syndrome (CRS) occurred in only 8.9% of patients, and importantly, all cases were Grade 1 (mild). No Neurotoxicity: No ICANS (Immune Effector Cell-Associated Neurotoxicity Syndrome) was observed.

Developer: Janssen Research & Development (a Johnson & Johnson company)

Pasritamig (JNJ-78278343) is a first-in-class bispecific T-cell–engaging antibody directed against human kallikrein-2 (KLK2), a prostate-specific serine protease highly expressed in metastatic castration-resistant prostate cancer (mCRPC). Its design enables selective T-cell redirection against KLK2-expressing tumor cells while minimizing off-tumor targeting, a long-standing limitation of T-cell therapies in prostate cancer. Based on emerging clinical activity and favorable tolerability, the FDA granted Fast Track designation in 2025, facilitating accelerated development and eligibility for priority review.

Presented by Capucine Baldini at ASCO 2025

Phase 1 results (NCT04898634) presented at ASCO and expanded at ESMO 2025 included 174 patients with mCRPC who had received ≥1 prior systemic therapies. Pasritamig displayed manageable toxicity, with 82.2% experiencing a treatment-related adverse event (TRAE), mostly low-grade. Grade ≥3 TRAEs occurred in only 9.2%, and CRS—typically a major concern with bispecifics—occurred in <10%, all Grade 1. The most frequent TRAEs at the recommended Phase 2 dose (RP2D) were infusion-related reactions (22.2%), fatigue (15.6%), and low-grade CRS (8.9%).

The RP2D regimen was established as:

• SUI 3.5 mg Day 1, SU2 18 mg Day 8, then
• 300 mg Day 15, followed by 300 mg every 6 weeks (Q6W) intravenously.

This schedule produced the most favorable balance between pharmacokinetics, immunologic engagement, and tolerability. In this RP2D cohort, the median radiographic PFS was 7.9 months (95% CI, 2.9–NE), and 42.4% of patients achieved a ≥50% PSA decline, an early marker of antitumor activity in mCRPC. Responses were observed across patients with extensive prior therapies and molecularly heterogeneous disease.

Presented by Capucine Baldini at ESMO 2025

At ESMO 2025, investigators presented a detailed translational analysis comparing dosing intervals. Weekly and Q3W dosing schedules were associated with rising PSA values and evidence of T-cell exhaustion. In contrast, Q6W dosing preserved a reprogrammable progenitor CD8⁺ T-cell compartment, characterized by lower expression of activated caspase-3 and γH2AX in peripheral blood mononuclear cells (n=186), indicating reduced activation-induced cell death (AICD). This immunologic preservation correlated with superior clinical activity: 44% of patients on the Q6W schedule achieved a complete response at any time, compared with 33% on Q3W.

Investigators emphasized that the degree of progenitor T-cell maintenance strongly correlated with PSA50 responses, independent of dose level, providing mechanistic validation that KLK2-directed T-cell redirection can produce clinically actionable immunity in prostate cancer.

Collectively, Phase 1 clinical and correlative data support pasritamig as a potentially impactful therapeutic strategy for mCRPC. It is the first agent to successfully leverage KLK2 as a T-cell–engaging target, with a safety profile compatible with outpatient delivery and enough preliminary efficacy to justify accelerated development. Upcoming Phase 2 studies are expected to further define its role within the evolving immunotherapy landscape for advanced prostate cancer.

10. Iza-bren (Izalontamab Brengitecan): An EGFR×HER3 ADC for  NSCLC, SCLC and Nasopharyngeal Cancer

Indication: EGFR-mutant NSCLC after third-generation EGFR TKI and platinum chemotherapy; recurrent/metastatic nasopharyngeal carcinoma (R/M-NPC) after ≥2l; relapsed/refractory small cell lung cancer (SCLC); NSCLC with non-classical oncogenic drivers.

Mechanism of Action: A first-in-class EGFR×HER3 bispecific antibody–drug conjugate linked to a topoisomerase-I inhibitor payload (Ed-04)

Key Trials: BL-B01D1-101/102 (Phase I/Ib); BL-B01D1-303 (Phase III NPC).

Main Results:

• NPC (Phase III): cORR 54.6% vs 27.0% with chemotherapy; median PFS 8.38 vs 4.34 months (HR 0.44); DoR 8.51 vs 4.76 months. OS immature. Grade ≥3 TRAEs 79.9%, predominantly hematologic, manageable with supportive care.
• NSCLC (Phase Ib): ORR 45.6%, cORR 35.3%, DCR 82.4%, median PFS 6.7 months across multiple oncogenic drivers. EGFR exon20ins and HER2 cohorts showed highest activity (cORR ~67%, DCR 100%). Only one low-grade ILD event.
• SCLC (Phase I): ORR 55.2%, confirmed ORR 44.8%, median PFS 4.0 months, OS 12.0 months. In patients with only one prior line of chemo-immunotherapy: ORR 80%, cORR 75%, median PFS 6.9 months, OS 15.1 months.

Safety: Class-typical topo-I ADC profile with predominantly hematologic toxicity

Developer: SystImmune and Bristol Myers Squibb (BMS)

Iza-bren (izalontamab brengitecan) is emerging as one of the most versatile next-generation ADCs in solid tumors, not because it targets a single niche mutation, but because it leverages a dual-receptor strategy that is relevant across multiple epithelial cancers. EGFR and HER3 form a powerful signaling pair: EGFR drives proliferation, while HER3 acts as an amplifier of ligand-mediated PI3K/AKT signaling and a key partner in resistance to targeted therapy. By co-targeting both and delivering a topoisomerase-I payload, iza-bren is designed to hit the signaling architecture and the DNA simultaneously.

The first indication where iza-bren looks truly practice-changing is recurrent/metastatic nasopharyngeal carcinoma. In BL-B01D1-303, a heavily pretreated R/M-NPC population (≥2 prior chemo lines, prior PD-(L)1) was randomized to iza-bren or physician’s-choice capecitabine, gemcitabine, or docetaxel. The interim analysis, presented as a late-breaking oral at ESMO 2025 and published in The Lancet, showed that iza-bren more than doubled confirmed ORR (54.6% vs 27.0%) and nearly doubled median PFS (8.38 vs 4.34 months; HR 0.44), with responses lasting almost twice as long (median DoR 8.51 vs 4.76 months). OS is not yet mature, but the magnitude of PFS and response benefit alone strongly suggests that this ADC can outperform late-line chemotherapy in a space with historically modest options.

Presented by Huaqiang Zhou at ESMO 2025

Toxicity in BL-B01D1-303 was dominated by myelosuppression, reflecting the potent topo-I payload, with grade ≥3 TRAEs in about 80% of patients versus 62% with chemotherapy. However, treatment discontinuation rates and non-hematologic toxicities were acceptable, and no new safety signals emerged compared with earlier studies.

Beyond NPC, iza-bren has generated a surprisingly broad signal in lung cancer. In the phase Ib NSCLC expansion presented at ASCO 2025, patients were enrolled by genotype rather than by histology—EGFR exon 20 insertions, atypical EGFR mutations, HER2, ALK/ROS1/RET fusions, KRAS (including G12C), BRAF, MET exon 14, NTRK, and SMARCA4. Most had progressed on standard targeted therapy when available and had received ≤1 prior line of chemotherapy. Shorten with AI

At the RP2D of 2.5 mg/kg D1D8 Q3W, the overall ORR was ~46%, with a cORR of 35% and DCR above 80%; median PFS was 6.7 months. The most striking activity was seen in EGFR exon 20 insertion and HER2-mutant disease, where confirmed response rates exceeded 50–65% and disease control was near-universal, with median PFS not reached in some cohorts at the time of reporting.Shorten with AI

Presented by Yan Huang at ASCO 2025

In SCLC, where meaningful progress has been rare, the phase I BL-B01D1-101 results are striking. Among 58 previously treated patients, iza-bren achieved an ORR of 55.2% (confirmed 44.8%), with median PFS 4.0 months and OS 12.0 months. Activity was even stronger in patients treated after only one prior line of PD-(L)1 plus platinum: ORR reached 80%, confirmed ORR 75%, and median PFS and OS were 6.9 and 15.1 months. These data justify the ongoing phase III trial in SCLC after one prior PD-(L)1 + platinum regimen (NCT06500026)

Why “Not Yet Approved” Still Matters Now

In oncology, “not yet approved” is not a technical footnote – it is the whole context. These medicines are still investigational: their safety and efficacy are being defined in controlled trials, not yet in everyday practice. Early response rates and PFS curves can look extraordinary, but until regulators review mature data in larger, more diverse populations, these drugs remain accessible mainly through clinical trials or carefully selected compassionate use. For patients and clinicians, that means hope, but not yet a standard of care.

The therapies highlighted here were selected by the OncoDaily Research & Intelligence Editorial Team based solely on the strength of their clinical data to date – agents showing meaningful activity in difficult cancers, innovative mechanisms, and the potential to shift treatment expectations if pivotal trials confirm their promise.

Together, this list of 10 most promising cancer drugs not yet approved, reflect the direction in which cancer medicine is moving—and remind us that tomorrow’s breakthroughs are already being written today.

Written by OncoDaily Research & Intelligence Editorial Team

The settlement ends an investigation opened in 2011 after Santander flagged potential wrongdoings at its branch in Paris, the prosecutor Laure Beccuau said in the statement, which confirmed an earlier report by BFM TV station.

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A judicial case started two years later over potential tax fraud, embezzlement and other offenses between 2003 and 2010, she added.

A Santander spokesperson said the bank had identified the issues 15 years ago and reported them back then.

The bank had provisioned for the settlement so it will not have an impact on its bottom line, he said.

“Santander remains committed to complying with the highest anti-money-laundering industry standards and regulations,” he said.

($1 = 0.8595 euros)

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To investigate how neural activation for correctly recalled memories varied across different time delays, we examined the contrast of remote >recent correct trials during object presentation at retrieval (Figure 4, ‘Retrieval fMRI’).

We first tested whether the remote > recent contrast significantly differed from zero in each age group and session (day 1 and day 14), as an indicator of differential engagement during memory retrieval. FDR-adjusted results showed no significant results in the anterior and posterior HC (Figure 4A), anterior PHG (Figure 4B), and RSC (Figure 4G) across sessions and age groups (all p>0.054; see Supplementary file 3 for details). To rule out the possibility that these nonsignificant differences reflect an overall absence of retrieval-related activation, we tested whether mean activation for recent and remote items – each relative to the implicit baseline – was significantly above zero. FDR-adjusted results revealed that activation in these ROIs was significantly greater than zero (all p<0.031), except in the recent day 1 condition in children for the posterior HC (p>0.141) and the precuneus (p>0.056, see Supplementary file 4 and Figure 4—figure supplement 1 for details). These findings indicate that the anterior and posterior HC, anterior PHG, and RSC are similarly engaged during successful retrieval of both recent and remote memories, regardless of delay or age group. (As a control analysis, we tested whether the anterior and posterior HC, anterior PHG, and RSC were similarly engaged during retrieval of recent and remote items over time using the LME models. These models included mean activation relative to the implicit baseline, a Session × Delay × Group interaction, and Subject as a random intercept. The results were consistent with the earlier findings, showing no significant main effect of Delay [all p>0.106], Group [all p>0.060], or Session × Delay interaction [all p>0.340], indicating comparable engagement of these ROIs across delays and age groups [see Supplementary file 6 for full statistical details].) Other ROIs showed more differentiated patterns, which are discussed below. (In contrast, the vlPFC, CE, posterior PHG and LOC, precuneus, and mPFC showed a significant main effect of Delay [all p<0.009, see Supplementary file 5 for details], indicating time-related changes in the remote > recent contrast. These effects are examined in more detail below. Notably, these findings are consistent with results from the whole-brain analyses; Supplementary file 7.)

To further explore the more differentiated patterns observed in other ROIs, we examined changes in the remote >recent contrast across age groups and sessions (day 1 and day 14) using LME models, controlling for sex, handedness, general intelligence, and mean reaction time. All main and interaction effects were FDR-adjusted, and all post hoc tests were Sidak-corrected (see Supplementary file 5 for details).

For the posterior PHG (Figure 4B), a significant Session × Group interaction, F_(1,83) = 9.54, p=0.020, ω²=0.09, indicated a more pronounced increase in remote >recent mean signal difference over time in young adults compared to children, b=0.11, t₍₈₃₎ = 3.09, p=0.003.

Similarly, also for the cerebellum (Figure 4C), a significant Session × Group interaction, F_(1,161) = 7.68, p=0.020, ω²=0.04, indicated a stronger increase in remote > recent mean signal difference over time in young adults compared to children, b=0.09, t₍₁₆₀₎ = 2.77, p=0.006.

For the mPFC (Figure 4D), a significant main effect of Group, F_(1,86) = 7.61, p=0.023, ω²=0.07, denoted that the overall remote > recent mean signal difference in children was higher than in young adults, b=–0.10, t₍₈₆₎ = –2.76, p=0.007.

For the vlPFC (Figure 4E), a significant main effect of Group, F_(1,82) = 31.35, p=<0.001, ω²=0.13, indicated an overall lower remote > recent mean signal difference in children compared to young adults, b=–0.125, t₍₁₀₈₎ = –3.91, p<0.001. In addition, a significant main effect of Session, F_(1,99)=10.68, p=0.005, ω²=0.09, pointed out overall higher remote > recent mean signal difference on day 14 compared to day 1, b=0.08, t₍₉₉₎ = 3.27, p=0.001.

For the precuneus (Figure 4F), a significant main effect of Group, F_(1,161) = 5.09, p=0.027, ω²=0.02, indicated an overall lower remote > recent mean signal difference in adults compared to children, b=–0.05, t₍₁₆₀₎ = –2.26, p=0.037. In addition, a significant main effect of Session, F_(1,161) = 6.50, p=0.036, ω²=0.03, denoted an overall lower remote > recent contrast for day 14 compared to day 1, b=–0.05, t₍₁₆₀₎ = –2.55, p=0.012. Although the remote > recent contrasts were mostly negative, the mean activation for recent and remote items – each relative to the implicit baseline – was significantly greater than zero for all delays and group (all p<0.023), except for children’s recent items on day 1 (p=0.056).

For the LOC (Figure 4H), a significant main effect of Group, F_(1,82) = 9.12, p=0.015, ω²=0.09, indicated a higher remote > recent mean signal difference in young adults compared to children, b=0.07, t₍₈₂₎ = 3.02, p=0.003. Additionally, a significant main effect of Session, F_(1,97) = 16.76, p=<0.001, ω²=0.14, showed an overall increase in remote > recent mean signal difference on day 14 compared to day 1, b=0.07, t₍₉₇₎ = 4.10, p=<0.001. Furthermore, a significant Session × Group interaction, F_(1,81) = 6.42, p=0.032, ω²=0.06, demonstrated higher increase in remote > recent mean signal difference over time in adults compared to children, b=0.09, t(81) = 2.53, p=0.013.

Of note, we conducted an additional univariate analysis using a subsample that included only participants who needed two learning cycles to reach the learning criteria (see Supplementary file 8 for details). The subsampled results fully replicated the findings from the full sample and demonstrated that the amount of re-exposure to stimuli during encoding did not affect consolidation-related changes in memory retrieval at the neural level.

In summary, our findings revealed distinct consolidation-related neural upregulation for remote memory between children and adults. From day 1 to day 14, adults showed a higher increase in remote > recent signal difference for remembered items in the posterior PHG, LOC, and cerebellum than children. Adults showed overall higher remote > recent difference in the vlPFC than children, while children showed overall higher remote > recent difference in the mPFC than adults. Furthermore, we observed a constant activation of anterior and posterior HC, anterior PHG, and RSC in memory retrieval across age groups irrespective of memory type or delay.