Transportation solutions that revolutionize the way the world moves
At Wabtec, we help our customers overcome their toughest challenges by delivering rail and industrial solutions that improve safety, efficiency and productivity.
30 Isabella Street
Pittsburgh, PA 15212 – USA
Phone: 412-825-1000
Fax: 412-825-1019
A new study shows datopotamab deruxtecan (Dato-DXd; Datroway; AstraZeneca) offers a meaningful survival advantage in a subgroup of patients with metastatic triple-negative breast cancer (mTNBC) who are not eligible for immunotherapy, according to recent data from the TROPION-Breast02 trial (NCT05374512).1,2
Antibody-drug conjugates (ADCs) continue to reshape the therapeutic landscape in oncology, offering targeted delivery of cytotoxic payloads to tumor cells. Dato-DXd is being investigated in multiple malignancies, including breast cancer.
The TROPION-Breast01 trial (NCT05104866) is a phase 3, open-label, randomized study that is designed to assess the efficacy of datopotamab deruxtecan relative to the investigator’s choice of single-agent chemotherapy (such as eribulin, capecitabine, vinorelbine, or gemcitabine) in patients with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer post 1 or 2 lines of chemotherapy. The major endpoints are progression-free survival (PFS) and overall survival (OS), while the study also gathers data on safety and quality of life as secondary objectives.3 The estimated date of completion is December 2025.3
Although TROPION-Breast01 concentrates on HR+ conditions, the TROPION-Breast02 trial is an entirely different, first-line metastatic TNBC study, which aims to compare datopotamab deruxtecan (6 mg/kg) with the investigator’s choice of chemotherapy in patients with previously untreated, inoperable, or mTNBC.4
TROPION-Breast02 results have already been made public through an AstraZeneca press release, which indicates a statistically significant and clinically meaningful increase in overall survival (OS) in the subgroup of patients who were immunotherapy non-candidates.4 Traditionally, it has been difficult to find benefits of overall survival in the first line of TNBC, especially in the group of patients who are not suitable for immunotherapy.2
According to AstraZeneca, datopotamab deruxtecan produced a survival advantage compared to standard chemotherapy in this first-line mTNBC population unable to receive immunotherapy.2 Datopotamab deruxtecan is reported as the first ADC and the only therapy to significantly improve OS in patients with metastatic TNBC for whom immunotherapy is not an option. The safety profile in TROPION-Breast02 was consistent with earlier trials of datopotamab in breast cancer, with no unexpected safety signals. Detailed hazard ratios and Kaplan–Meier survival curves are expected to be presented at an upcoming medical meeting.2
In the TROPION-Breast01 trial, datopotamab deruxtecan met its dual primary endpoint of PFS: datopotamab deruxtecan reduced the risk of disease progression or death by 37% compared to chemotherapy in patients with inoperable or metastatic HR+/HER2– disease.5 However, in a subsequent final OS analysis, the drug did not achieve statistical significance in overall survival versus chemotherapy.4 No new safety concerns emerged, and rates of treatment-related adverse events and interstitial lung disease (ILD) remained low. The failure to meet OS in Breast01 underscores the challenges of demonstrating life-extension benefits when subsequent lines of therapy may confound survival.4
Because TROPION-Breast01 and TROPION-Breast02 are linked, this underscores the importance of understanding how regulatory decision-makers view surrogate endpoints vs. OS in ADC trials for breast cancer. AstraZeneca has filed a biologics license application for datopotamab deruxtecan in HR+/HER2– metastatic breast cancer, supported by the PFS data from TROPION-Breast01.4
The TROPION-Breast02 trial results suggest that datopotamab deruxtecan may establish a new standard for first-line therapy in mTNBC patients who cannot receive immunotherapy by demonstrating an OS benefit compared to chemotherapy. These findings build on the PFS success in the HR+ setting TROPION-Breast01, albeit tempered by the lack of OS statistical significance in that earlier trial. As the oncology field digests the full data, pharmacists will play an essential role in safe implementation, monitoring, formulary decision-making, and patient education.
September brought a series of pivotal updates in non–small cell lung cancer (NSCLC) treatment, including FDA regulatory decisions, late-breaking clinical trial results, and expert insights from the 2025
Highlights include breakthrough therapy designations for frontline zongertinib (Hernexeos) and olomorasib plus pembrolizumab (Keytruda), fast track designations for TT125-802, important survival and progression outcomes from the phase 3 FLAURA2 (NCT04035486) and HARMONi (NCT06396065) trials, and discussions on the growing role of comprehensive molecular testing and emerging therapies like sunvozertinib (Zegfrovy), underscoring the ongoing evolution of personalized care in lung cancer.
Check out this month-in-review recap of OncLive’s coverage of the top news and expert insights in lung cancer:
The FDA has granted breakthrough therapy designation to zongertinib for frontline use in adults with HER2-mutant unresectable or metastatic nonsquamous NSCLC based on results from the phase 1b Beamion LUNG-1 trial (NCT04886804) showing a 71% confirmed objective response rate and median progression-free survival (PFS) of 12.4 months at the 120-mg dose.1 This designation follows the agent’s accelerated approval for previously treated disease and reflects ongoing evaluation of its potential role earlier in the treatment course.
The regulatory agency granted breakthrough therapy designation to olomorasib plus pembrolizumab for the first-line treatment of patients with unresectable or metastatic NSCLC harboring a KRAS G12C mutation and PD-L1 expression of 50% or higher, based on findings from the phase 1/2 LOXO-RAS-20001 (NCT04956640) and phase 3 SUNRAY-01 (NCT06119581) trials.2 Data from LOXO-RAS-20001 revealed an overall response rate of 74% and a disease control rate of 91%, supporting further evaluation of the combination in the ongoing SUNRAY program.
The FDA has granted two fast track designations to the small molecule CBP/p300 bromodomain inhibitor TT125-802 for the treatment of patients with locally advanced or metastatic NSCLC and EGFR exon 19 deletions or exon 21 L858R mutations after prior EGFR inhibitor exposure, and for those with KRAS G12C–mutated disease progressing following a KRAS G12C inhibitor.3 The designations are supported by early findings from the phase 1 TT-CSP-001 trial (NCT06403436), which showed signs of clinical benefit and a favorable safety profile in patients with advanced solid tumors, including NSCLC.
The International Association for the Study of Lung Cancer’s World Conference on Lung Cancer was held in Barcelona, Spain, and ran from September 6-9, 2025, bringing 4 days of data-driven discussions on evolving treatment paradigms, emerging therapeutic approaches, and critical progress in lung cancer care. OncLive editors spoke with several experts to spotlight the most important research to come out of the meeting—those insights can be found in this
The top updates to come out of the meeting included data from:
At the meeting, Chandler Park, MD, MSc, FACP, of Nortion Cancer Institute, and Eric K. Singhi, MD, of The University of Texas MD Anderson Cancer Center, hosted
In a recent feature, lung cancer experts delved into the evolving NSCLC treatment paradigm, highlighting that the expansion of targeted therapies has increased the importance of comprehensive molecular testing, including both DNA- and RNA-based platforms, as well as immunohistochemistry for PD-L1, HER2, and MET. They emphasized that although tissue-based testing remains the gold standard, barriers such as insufficient tissue and access limitations make liquid biopsy and repeat sampling critical, and emerging technologies like artificial intelligence could help streamline testing, improve result interpretation, and ultimately support more personalized therapeutic approaches.
In a recent interview,
Stay on top of the
Czech annual inflation eased to 2.3% in September, coming in 0.3ppt below market and Czech National Bank expectations. The main drag was a pronounced decline in food prices. Given the limited breakdown of the preliminary estimate, we also see some potential for weaker regulated prices, mainly through lower energy components. Annual price growth in the service segment remained unchanged at 4.7% in September, while price dynamics in the goods segment eased to 0.8% in September from 1.1% previously. We estimate that core inflation likely softened marginally to some 2.7%, coming in 0.1ppt below the CNB’s summer forecast.
The thing is that food prices at this time of the year are heavily affected by the crop season, which can put downward pressure on price tags, especially when it comes to unprocessed foodstuffs such as vegetables and fruits. This was also the case in the latest CPI preliminary estimate, when the annual price dynamics for unprocessed food eased noticeably to 3.4% in September from 7.8% previously, declining 2.1% on a monthly basis. The agricultural producer’s data provides a decent indication of what is going on in the food sector, with crop product prices decreasing since May, while prices of animal production continued to gain over the same period. As a result, crop products added only 4.6% annually in August, while annual growth in prices of animal products crept up to 18.9% in the same month, a record pace observed since April 2023.
From sparking creativity to fueling education and scientific research, open heritage generates positive ripple effects across society. Yet, only about 1% of cultural heritage institutions openly share their heritage collections. Incorrect copyright claims over digital reproductions, technological locks, prohibitive access fees, lack of sustainable infrastructure, and inconsistent legal frameworks are just some of the barriers that stand in the way of equitable access to heritage. The result is fragmented and fragile access that prevents people from engaging with heritage, our shared resource.
This launch builds on Creative Commons’ long-standing collaboration with UNESCO, as formalized by our recent recognition as an official partner to UNESCO (consultative status). It is also an answer to the call made by UNESCO at MONDIACULT 2025 — the world’s largest conference on cultural policies — for culture to be treated as a global priority amid mounting geopolitical divides and multiple crises.
Signing the Open Heritage Statement is more than symbolic; it is a way for signatories to demonstrate shared commitment, signal broad sectoral consensus to policymakers, and strengthen a global, community-driven movement. Each signature helps build momentum toward an international framework to ensure equitable access to heritage in the digital environment.
Creative Commons will host a webinar to mark the launch of the Statement and brief participants on its objectives, impact, and opportunities for engagement.
Date: 14 October 2025
Time: 14:00 UTC
Register here
By signing the Open Heritage Statement today, you add your voice to a global call for equitable access to heritage, helping to lower barriers, stimulate creativity, and preserve our cultural memory for future generations.
Learn more about the Open Heritage Statement.
Posted 06 October 2025
Breast cancer clinical trials face unique challenges due to the disease’s biological complexity, heterogeneity, diverse patient population and rapidly evolving treatment landscape. The biological heterogeneity of breast cancer creates opportunities to tailor interventions across the treatment continuum, but also introduces complexity in clinical trial design, requiring nuanced eligibility criteria and stratified enrollment strategies that can slow recruitment and complicate statistical analysis.
Trials must account for multiple molecular subtypes, which can limit eligible participants and complicate study design. Recruitment is often hindered by restrictive eligibility criteria, lack of awareness and underrepresentation. Additionally, the fast pace of therapeutic innovation can render control arms outdated, requiring adaptive trial designs that are resource-intensive and statistically demanding.
Data from the phase 3 ICONIC-ADVANCE 1 (NCT06143878) and 2 (NCT06220604) clinical trials show that icotrokinra demonstrated superiority to deucravacitinib (Sotyktu; Bristol Myers Squibb) at multiple timepoints in adults with moderate-to-severe plaque psoriasis (PsO), with superior skin clearance at weeks 16 and 24 and numerically lower rates of adverse events (AEs) versus deucravacitinib, according to a news release from Johnson & Johnson.1-3
Long-term data from the 52-week phase 3 ICONIC-LEAD (NCT06095115) study also indicated sustained skin clearance and favorable safety, key indicators of maintained efficacy and improved quality of life. The data were presented at the 2025 European Academy of Dermatology and Venereology (EADV).1,4
Icotrokinra, a first-in-class, investigational targeted oral peptide, has demonstrated significant efficacy and safety in individuals with PsO. Prior studies and analysis have affirmed such efficacy, with past data from ICONIC-LEAD indicating significant skin clearance in adults and adolescents aged 12 and older with moderate-to-severe PsO through 24 weeks. In ICONIC-TOTAL, individuals with difficult-to-treat scalp and genital psoriasis achieved improvements in skin clearance using icotrokinra.5,6
Other standard-of-care options remain available, including deucravacitinib, a once-daily oral tyrosine kinase 2 inhibitor that has shown superior efficacy and safety to other agents. To fully elucidate the comparative effects between icotrokinra and deucravacitinib, ICONIC investigators initiated ICONIC-ADVANCE, comparing icotrokinra against both placebo and deucravacitinib.1
In ICONIC-ADVANCE 1 and 2, icotrokinra demonstrated superior skin clearance versus placebo at week 16 and deucravacitinib at weeks 16 and 24. Furthermore, icotrokinra demonstrated similar rates of adverse events (AEs) to placebo with no novel safety signals, while eliciting numerically lower rates of AEs compared with deucravacitinib through week 24. The data indicate the immense promise of icotrokinra to more meaningfully clear skin in patients with PsO compared with standard care, providing an effective new option for patients struggling with itch and quality of life burdens.1
“These head-to-head data clearly demonstrate superior complete skin clearance rates for icotrokinra compared to deucravacitinib,” Linda Stein Gold, MD, ICONIC-ADVANCE study investigator, said in the news release. “With significantly higher response rates seen as early as week 16 and increasing at week 24, this novel targeted oral peptide treatment has the potential to be an appealing new option for patients with moderate-to-severe plaque psoriasis.”1
Novel, long-term data from ICONIC-LEAD was also presented at EADV. Through week 52, icotrokinra demonstrated sustained, meaningful skin clearance and a safety profile that was favorable and consistent with prior research, with no new safety signals identified. At week 52, adult responders to icotrokinra—according to the Psoriasis Area and Severity Index (PASI) 90 score—who were re-randomized to icotrokinra at week 24 had superior maintenance of PASI 90 response versus those re-randomized to placebo (84% versus 21%; P < .001).1
Additionally, at week 52, 86% of adolescents who were administered icotrokinra for the full 52 weeks—and 77% of those who switched from placebo to icotrokinra at week 16—achieved quality PASI 90 responses. This demonstrates the feasibility of switching from another treatment to icotrokinra while not inducing any reductions in therapeutic effects. The data also indicates the long-term and sustained responses to icotrokinra as far as a year after treatment initiation, allowing patients to maintain their skin clearance and improve their quality of life without having setbacks.1
“With a substantial proportion of adults and adolescents achieving clear or almost clear skin while maintaining a favorable safety profile through 52 weeks, icotrokinra could be a compelling new therapeutic option that aligns with both patient and provider goals for an oral treatment once approved,” Jennifer Soung, MD, ICONIC-LEAD study investigator, said in the news release.1
As icotrokinra continues through the ICONIC clinical development program, pharmacists should be sure to keep an eye on its regulatory status. The drug remains not yet approved, although Johnson & Johnson has submitted a new drug application to the FDA for icotrokinra’s consideration. They should familiarize themselves with facets of icotrokinra’s administration, including recommended dosage (as outlined in clinical trials), once-daily adherence, efficacy onset, and the duration of the therapy.
Pharmacists should be sure that patients undergo a baseline screening before using icotrokinra if the medication is approved to ensure a patient’s medical history—including past infections—is well known. Pharmacists also stand to play a critical role in monitoring for adverse events, while counseling patients on expected outcomes and a timeline for skin clearance.
