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Document last modified Date: June 2, 2025
The Release Notes include information concerning the release of a new Magic: The Gathering set, as well as a collection of clarifications and rulings involving that set’s…
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Ivonescimab HARMONi-A Study Final OS Analysis Results Presented at SITC 2025 with OS HR=0.74
- The HARMONi-A study is the first Phase III trial of an immunotherapy for EGFR-TKI-resistant, EGFR-mutated non-squamous NSCLC to show statistically significant and clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS)
- With a median follow-up of 32.5 months, the ivonescimab combination regimen showed a median OS of 16.8 months, versus 14.1 months for chemotherapy (OS HR=0.74, P=0.019)
- The OS benefit of the ivonescimab combination regimen was consistent across all subgroups, showing significant improvement regardless of the presence of brain metastases or EGFR mutations (19Del and L858R)
- During the 32.5-month follow-up period, the ivonescimab combination regimen demonstrated excellent safety
- These are the final and only formal OS analysis results from the HARMONi-A study
- Ivonescimab was approved for market launch in China in May 2024 and was added to the National Reimbursement Drug List (NRDL) in November 2024
HONG KONG, Nov. 7, 2025 /PRNewswire/ — Akeso, Inc. (HKEX: 9926.HK) is excited to announce that the final Overall Survival (OS) analysis results from the HARMONi-A study, a Phase III study evaluating ivonescimab combined with chemotherapy for the treatment of EGFR-mutated non-squamous non-small cell lung cancer (nsq-NSCLC) following EGFR-TKI progression, were selected as a “Late-Breaking Abstract” (LBA) for the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), held in National Harbor, Maryland, USA. Professor Xiuning Le from MD Anderson Cancer Center presented these findings to a global audience during an oral presentation session.
HARMONi-A is the first global Phase III clinical trial of an immunotherapy in the EGFR-TKI resistant, EGFR-mutated nsq-NSCLC setting to demonstrate clinically meaningful and statistically significant benefits in both Progression-Free Survival (PFS) and Overall Survival (OS). This final OS analysis, the first from a Phase III trial of ivonescimab, confirms the breakthrough value of ivonescimab-based therapy in improving both PFS and OS. Historically, cancer immunotherapies have largely failed to demonstrate significant breakthroughs in this specific indication. Prior Phase III trials involving other regimens—such as PD-1 inhibitors combined with chemotherapy or immunotherapies combined with anti-angiogenic therapy, failed to show significant OS benefits. The significant positive outcomes in both PFS and OS in the HARMONi-A study underscore the substantial clinical benefit improvement of ivonescimab over PD-1 inhibitors.
Previously, the HARMONi-A study had already met its primary endpoint, demonstrating a statistically significant improvement in PFS at the interim analysis (PFS HR 0.46, P < 0.001). Previously, during the regulatory review for the approval of ivonescimab in first-line PD-L1-positive NSCLC in China, a descriptive analysis of OS from the HARMONi-A study was conducted in May 2024 at the request of the regulatory authorities. The final OS analysis results presented at SITC 2025 represent the final and only pre-specified formal OS analysis for the HARMONi-A study, performed as a sequential test according to the pre-specified statistical analysis plan (SAP).
The final OS analysis, with a median follow-up period of 32.5 months, showed that the ivonescimab plus chemotherapy regimen provided a clinically meaningful and statistically significant improvement in OS compared to chemotherapy alone:
- The median OS was 16.8 months in the ivonescimab treatment group compared to 14.1 months in the control group (OS HR=0.74, P=0.019), achieving statistical significance. The OS benefit increased with extended follow-up.
- The ivonescimab combination regimen consistently demonstrated OS benefit over the control group across all subgroups:
- In patients with brain metastases, OS HR=0.61;
- In patients without brain metastases, OS HR=0.77;
- In patients with EGFR 19Del mutations, OS HR=0.83;
- In patients with EGFR L858R mutations, OS HR=0.60.
With a median follow-up of 32.5 months, the long-term safety profile of the ivonescimab combination therapy remained favorable, with no new safety signals identified. The incidence of common treatment-related adverse events (TRAEs) showed no significant difference between the two groups.
Based on the positive clinical data from the HARMONi-A study, ivonescimab received approval from the China National Medical Products Administration in May 2024 for this indication. In November 2024, Akeso announced that ivonescimab was successfully added to China’s National Reimbursement Drug List, effective January 1, 2025, ensuring widespread patient access to this life-saving treatment.
Additionally, Summit Therapeutics, Akeso’s global partner for ivonescimab, announced in October 2025 that it plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025, seeking approval for ivonescimab in combination with chemotherapy for the treatment of EGFR-mutant, third-generation EGFR-TKI-resistant, non-squamous NSCLC.
Forward-Looking Statement of Akeso, Inc.
This announcement by Akeso, Inc. (9926.HK, “Akeso”) contains “forward-looking statements”. These statements reflect the current beliefs and expectations of Akeso’s management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso’s other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.
About Akeso
Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world’s first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin.
SOURCE Akeso, Inc.
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In Your Dreams review – Netflix dreams up solid sub-Pixar adventure | Animation in film
Once upon a time, Pixar had the kind of winning streak that most companies could only dream of. The studio didn’t just maintain a robust production line that won over both critics and crowds, they also managed to change our concept of what…
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Kia MVP Ladder: Shai Gilgeous-Alexander picks up where he left off
Shai Gilgeous-Alexander has been on an epic run as a scorer since last season.
When former NBA commissioner David Stern, with an assist from FIBA, devised a plan decades ago to open the doors to foreign players, did anyone expect those doors to…
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‘Unlike any we’ve ever seen’: Record-breaking black hole eruption is brighter than 10 trillion suns
A supermassive black hole appears to have generated a record flare after gobbling a star at least 30 times more massive than the sun.
The event has yet to be confirmed as a tidal disruption event (TDE), which happens when a black hole devours a…
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Could Arsenal be the team to end Chelsea’s unbeaten run in WSL?
While Chelsea have stayed unbeaten at the start of 2025-26 campaign and sit top of the WSL table, Arsenal have been less fortunate.
The Gunners’ hopes of a title charge suffered an early blow with a defeat by Manchester City and draws against…
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What Whales, Elephants And Tardigrades Reveal About Longevity
Longevity and disease resistance in humans may soon be transformed by studying and emulating the genetic strategies encoded in nature’s most resilient and long-lived species.
ACCESS Health International
Longevity and disease resistance in humans…
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‘Worrying reports’ continue of abductions and disappearances in Syria
“Eleven months after the fall of the former government in Syria, we continue to receive worrying reports about dozens of abductions and enforced disappearances,” Spokesperson Thameen Al-Keetan said at a press briefing in Geneva.
Syria is…
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Rhythmic sampling and competition of target and distractor in a motion detection task
Sustained visual attention is required in many real-life situations such as driving a vehicle or operating machinery and is characterized by limited capacity; not all information available to the visual system can be processed in-depth. Recent work has suggested that to manage the limited capacity problem, the visual system samples the attended information in a rhythmic fashion, mediated by low-frequency intrinsic brain oscillations (Chota et al., 2022; Dugué et al., 2015; Fiebelkorn et al., 2013; Fiebelkorn et al., 2018; Fiebelkorn and Kastner, 2019; Helfrich et al., 2018; Michel et al., 2022; Re et al., 2019; VanRullen, 2013; Zalta et al., 2020). In this view, the cycle of a low-frequency intrinsic brain oscillation can be divided into two phases: a high excitability phase and a low excitability phase. When a stimulus occurs during the high excitability phase, behavioral performance tends to be better than average; conversely, if the stimulus occurs during the low excitability phase, performance is generally worse than average (Lakatos et al., 2008; VanRullen, 2013). Behavioral performance may thus exhibit rhythmic fluctuations at the frequency of the aforementioned low-frequency intrinsic brain oscillation. One paradigm that has been used to test the idea of rhythmic visual sampling is the cue-target paradigm (Posner, 1980; Posner et al., 1987; Posner et al., 1988). The cue at the beginning of each trial, in addition to providing instructions on how the impending target stimulus should be responded to, helps to reset the phase of the low-frequency intrinsic oscillation such that all the trials start at approximately the same phase. By varying the stimulus onset asynchrony (SOA) between the cue and the target, one obtains the behavioral response (e.g. accuracy and/or reaction time) as a function of the SOA. The rhythmic nature and the frequency of this function can then be assessed by applying time-domain and/or spectral-domain analysis.
When attending to one object in isolation, the frequency of rhythmic sampling tends to be in the high theta or low alpha frequency range, i.e., around 8 Hz (Fiebelkorn et al., 2013; Senoussi et al., 2019; van der Werf et al., 2023). When attention is directed to multiple objects in the environment, it has been suggested that rather than sampling all the objects simultaneously, the brain samples the objects in a serial fashion (Cohen et al., 1990; Wyart et al., 2012). This would then lead to a slower rhythmic sampling of any given object, in the low range of the theta frequency band, i.e., around 4 Hz (Thigpen et al., 2019). For example, when participants were cued to attend one visual hemifield but were asked to detect the appearance of a weak stimulus in either the cued or the uncued visual hemifield, the rhythmic detection rate for the target appearing in a given visual hemifield decreased from 8 Hz to 4 Hz (Chota et al., 2022; Fiebelkorn et al., 2013; VanRullen, 2013). Interestingly, when the detection rate functions of the cued and uncued targets were compared, a 180-degree relative phase was apparent, suggesting that the visual system indeed sampled the two visual hemifields in a serial, alternating fashion (Fiebelkorn et al., 2013; Jiang et al., 2024). In another example, two spatially overlapping clouds of moving dots, one in red color and the other in blue color, moved in orthogonal directions (Re et al., 2019), and the participant was cued to attend both the red dots and the blue dots and instructed to report the change in either the red dots or the blue dots as soon as it occurred. When there was only one cloud of moving dots, the detection accuracy exhibited rhythmic fluctuations as a function of the SOA at a frequency around 8 Hz. When both clouds of moving dots were present, rhythmic fluctuations in the accuracy of detecting changes in a given cloud of moving dots were again identified, and the sampling frequency was reduced to 4 Hz. In this case, however, no apparent 180-degree relative phase between the rhythmic behavioral response functions to the red and blue dots was found, suggesting that there was no serial, alternating sampling between the two attended objects if they appeared at the same spatial location.
The real world visual environment contains both task-relevant information (target) and task-irrelevant (distractor) information. It is well established that in the presence of a distractor, the processing of the target is negatively impacted, leading to reduced task performance (Lavie, 2005; Murphy et al., 2016). This implies that the distractor, despite the need for it to be suppressed by the brain’s executive control system (Kastner et al., 1998; Kastner et al., 1999; Kastner and Pinsk, 2004; Seidl et al., 2012; Kastner and Ungerleider, 2000), is nevertheless processed in the brain, and the competition between the target and the distractor at the neural representational level causes the detriment in behavioral performance. Does the rhythmic sampling theory extend to the target-distractor scenario? If so, what is the temporal relationship between the rhythmic sampling of attended vs distracting stimuli? These questions have hitherto not been addressed. Part of the reason is that the majority of the studies on rhythmic environmental sampling focuses on behavioral evidence, e.g., rhythmicity in the aforementioned performance-vs-SOA function (Fiebelkorn and Kastner, 2019; Landau and Fries, 2012). Since the distractor is not responded to, its sampling by the visual system cannot be inferred purely on the basis of response behavior, and consequently, it is also not possible to study how the target and the distractor might compete for neural representations purely behaviorally.
In this study, we addressed these limitations by recording neural activities and investigating rhythmic sampling during a target-distractor scenario using steady-state visual evoked potential (SSVEP) frequency tagging. The stimuli were a cloud of randomly moving dots (the target) superimposed on emotional images from the International Affective Picture System (IAPS; Lang et al., 1997) (the distractor). The target and the distractor were flickered at two different frequencies for an extended duration of ~12 s. The participants were asked to focus on the randomly moving dots and report the number of times the dots moved coherently. In this paradigm, the onset of the stimulus array is the event that resets the phase of the putative low-frequency brain oscillation underlying rhythmic sampling, and the time from the stimulus array onset, referred to as time-from-onset (TFO), is analogous to the SOA in the traditional cue-target paradigm. It is worth noting that, although this paradigm has been used extensively in studies of target-distractor competition with electroencephalography (EEG) (Hindi Attar and Müller, 2012; Müller et al., 2008), it has not yet been examined in the context of rhythmic sampling. Aided by frequency tagging, from the EEG data, we extracted neural representations of target and distractor processing separately as a function of TFO. By examining the rhythmicity of these representations as functions of TFO and the phase relationship between these functions, we assessed (1) whether the target and the distractor were sampled rhythmically and (2) how their temporal competition for neural representations impacted behavioral performance.
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Milutin Osmajic: Preston forward given nine-game ban for racially abusing Hannibal
Preston North End forward Milutin Osmajic has been given a nine-game ban after he was charged with racially abusing Burnley midfielder Hannibal Mejbri.
The incident happened during Preston’s goalless draw with Burnley in February and the…
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