Amivantamab-VMJM

Peer-reviewed results from the global Phase III HARMONi trial have confirmed a significant PFS benefit for ivonescimab in EGFR-mutated NSCLC, but the study's primary overall survival (OS) analysis remained non-significant ahead of a US FDA decision due November 14, 2026. The primary analysis of the trial data was published in The Lancet Oncology, while Summit Therapeutics Inc.'s (Nasdaq: SMMT) press release plans to present updated OS data at the World Conference on Lung Cancer (WCLC 2026) on September 15, 2026. HARMONi is a randomized, double-blind, placebo-controlled Phase III trial enrolling patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose disease progressed after a third-generation EGFR tyrosine kinase inhibitor (TKI). The study ran across 114 centers in Asia, Europe, and North America. At the primary analysis, ivonescimab plus platinum-doublet chemotherapy produced a median progression-free survival (PFS) of 6.8 months versus 4.4 months with placebo plus chemotherapy, a hazard ratio of 0.52 (95% CI: 0.41–0.66; p<0.0001) assessed by independent radiographic review. The PFS benefit was consistent across preplanned subgroups. At the time of the primary OS analysis, the combination showed a positive OS trend that did not reach statistical significance. Treatment-related grade 3–5 hemorrhage events occurred in fewer than 1% of patients in the ivonescimab arm, consistent with prior clinical experience, Summit said. Ivonescimab simultaneously blocks PD-1 and vascular endothelial growth factor (VEGF) through a single tetravalent bispecific antibody engineered by China-based Akeso Inc. (HKEX: 9926.HK). The molecule is designed to preferentially accumulate in the tumor microenvironment, where both PD-1 and VEGF are more highly expressed than in normal tissue. Summit holds commercialization rights in North America, South America, Europe, the Middle East, Africa, and Japan; Akeso retains rights elsewhere, including China, where ivonescimab was first approved in May 2024 for EGFR-TKI-resistant non-squamous NSCLC. The post-third-generation TKI setting has historically resisted immunotherapy. Prior Phase III studies of PD-1 monoclonal antibodies failed to show PFS or OS benefit in this population, making HARMONi's statistically significant PFS result the first for an immunotherapy-based regimen in a global trial of this kind, Summit said. An updated OS analysis based on a June 2026 data cut showed a continued positive OS trend, with western patients achieving an OS hazard ratio of 0.76, consistent with the overall study population. That data will be presented at WCLC 2026. The HARMONi-A study — a single-region China-based predecessor trial in a similar population — demonstrated a statistically significant OS benefit (HR 0.74; p=0.019), providing supportive context for the global dataset. Summit proceeded with its BLA submission based on the PFS result and the positive OS trend, citing the absence of any FDA-approved regimen with demonstrated OS benefit in this patient population and the consistency of results between Asian and western cohorts. The PDUFA goal action date is November 14, 2026. In the US, Johnson & Johnson's EGFR/MET-targeted bispecific antibody Rybrevant (amivantamab-vmjw) is approved with carboplatin and pemetrexed for patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R mutations whose disease has progressed on or after an EGFR TKI. That molecule's September 2024 approval was based on the Phase III MARIPOSA-2 trial, in which the regimen produced a median PFS of 6.3 months versus 4.2 months with chemotherapy alone (HR 0.48; 95% CI: 0.36–0.64). Ivonescimab combines PD-1 and VEGF blockade, potentially providing a mechanistically distinct treatment option if approved. Cross-trial comparisons between HARMONi and MARIPOSA-2 remain limited by differences in eligibility criteria, comparator arms, and study design. Summit's global Phase III program for ivonescimab now spans five company-sponsored studies, including HARMONi-3 (first-line NSCLC versus Merck's Keytruda (pembrolizumab) plus chemotherapy), HARMONi-7 (first-line high PD-L1 NSCLC monotherapy versus pembrolizumab), HARMONi-GI3 (first-line metastatic colorectal cancer), and HARMONi-GU1 (first-line urothelial carcinoma). Akeso separately received NMPA approval in August 2026 for ivonescimab plus chemotherapy in first-line squamous NSCLC based on HARMONi-6 OS data — the third approved indication for the molecule in China. Access the AllSci platform to explore the science behind the news. Spot something wrong? Report an issue with this article

CAMBRIDGE, Mass., Aug. 25, 2026 (GLOBE NEWSWIRE) -- Parabilis Medicines (Nasdaq: PBLS), a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking historically undruggable targets, today announced the appointment of Craig L. Tendler, M.D., to its Board of Directors. Dr. Tendler previously led both clinical development and medical affairs for oncology at Johnson & Johnson. He has served as a scientific advisor to Parabilis Medicines, a role he will continue alongside his Board responsibilities. “We are delighted to welcome Craig to the Parabilis Board of Directors,” said Mathai Mammen, M.D., Ph.D., Chairman, CEO and President of Parabilis Medicines. “I have known Craig for many years and know the rigor, judgment and creativity he brings. His unparalleled experience guiding innovative medicines from clinical development and global approval through subsequent product adoption and medical affairs will be tremendously valuable to Parabilis as we continue to advance zolucatetide across multiple indications and build our broader pipeline of Helicon TM therapeutics. I consider Craig to be one of the most prolific oncology drug developers in our industry. He has a strategic mind and is driven by patient needs in all that he does.” “Throughout my career, I have seen the difference that opening new therapeutic avenues can make for patients,” said Dr. Tendler. “I am pleased to join the Board of Parabilis at this pivotal time and complement its efforts to translate clinical insights into strategies that accelerate the development and approval of potentially transformational therapies such as zolucatetide.” Dr. Tendler brings more than 30 years of experience in oncology drug development and medical affairs, including two decades at Johnson & Johnson, where he held leadership roles across clinical development, medical affairs and business development and most recently served as Global Head of Late-Stage Clinical Development and Global Medical Affairs for Oncology. During his tenure at J&J, he played a key role in securing more than 30 oncology regulatory approvals across prostate cancer (ZYTIGA®, AKEEGA® and ERLEADA®), hematologic malignancies (DARZALEX®, CARVYKTI®, TECVAYLI®, TALVEY®, IMBRUVICA®), lung cancer (RYBREVANT®) and bladder cancer (BALVERSA®), as well as 13 FDA Breakthrough Therapy designations and approvals for 15 New Molecular Entities (NMEs). He also worked closely with clinical and commercial teams to support the practical adoption of many of these practice-changing medicines through medical affairs data generation activities in collaboration with academic and community-based investigators. Dr. Tendler also played an integral role in securing major oncology business development transactions and collaborations, including J&J’s acquisitions of Cougar Biotechnology, Aragon Pharmaceuticals and Taris Biomedical and co-development partnerships with Legend Biotech, Pharmacyclics and Genmab. Before joining J&J, Dr. Tendler spent nearly a decade at the Schering-Plough Research Institute, where he held positions of increasing responsibility in oncology clinical research. Earlier in his career, he served as an Assistant Professor of Pediatrics and Pediatric Hematology/Oncology at the Mount Sinai School of Medicine and was an NIH physician-scientist grant recipient and research fellow at the National Cancer Institute. He continues to serve as an Adjunct Assistant Professor of Pediatrics at Mount Sinai. Dr. Tendler currently serves on the Board of Directors of TuHURA Biosciences and Predicta Biosciences and as a scientific advisor for several biotechnology companies. He is also an alternate industry representative to the FDA’s Oncologic Drugs Advisory Committee. He earned his M.D. with high honors from Mount Sinai. About Parabilis Medicines Parabilis Medicines (Nasdaq: PBLS) is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable. The company has pioneered a new class of alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that have historically been beyond the reach of conventional medicines. The company’s lead investigational medicine, zolucatetide, is the first and only direct inhibitor of the β-catenin:TCF interaction, a central node in the Wnt/β-catenin pathway that has eluded drug developers for decades. Zolucatetide is being evaluated in the clinic across multiple Wnt/β-catenin-driven diseases, including desmoid tumors, familial adenomatous polyposis (FAP), adamantinomatous craniopharyngioma (ACP), hepatocellular carcinoma (HCC) and a range of other rare and common solid tumor indications. Beyond zolucatetide, Parabilis is pursuing a follow-on β-catenin degrader program and advancing additional Helicon-based programs focused on other challenging targets, including ERG and allosteric AR ON in prostate cancer, where we believe our medicines could have life-altering impact. For more information, visit or follow us on LinkedIn . Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, statements relating to the expected contributions and impact of Dr. Tendler’s contributions to the Company; and other statements regarding the Company’s future plans, objectives, and financial and operational performance. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks and uncertainties that could negatively affect the Company’s business, operating results, financial condition and stock value. Factors that could cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release include, without limitation: risks relating to the Company’s research and development activities; the Company’s ability to execute on its strategy, including obtaining the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to preclinical and clinical development activities; the Company’s dependence on third parties to conduct clinical trials, manufacture its product candidates and develop and commercialize its product candidates, if approved; the Company’s ability to attract, integrate and retain key personnel; risks related to the Company’s financial condition and need for substantial additional funds in order to complete development activities and commercialize a product candidate, if approved; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; risks related to establishing and maintaining the Company’s intellectual property protections; and risks related to the competitive landscape for the Company’s product candidates; as well as other risks and uncertainties described in greater detail in “Risk Factors,” in the Company’s most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent the Company’s views only as of today and should not be relied upon as representing its views as of any subsequent date. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Media Contact: Jessica Freifeld media@parabilismed.com Investor Contact: Tom Kotarakos investors@parabilismed.com