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HARMONi-2, Featuring Ivonescimab Monotherapy vs. Pembrolizumab Monotherapy, to be Showcased in Presidential Symposium at WCLC 2024
Monotherapy Ivonescimab Achieved Clinically Meaningful PFS Benefit Compared to Monotherapy Pembrolizumab in HARMONi-2 Trial Conducted by Akeso Ivonescimab Is
About this update from Summit Therapeutics Inc.
[{"type":"text","content":"\nMonotherapy Ivonescimab Achieved Clinically Meaningful PFS Benefit Compared to Monotherapy Pembrolizumab in HARMONi-2 Trial Conducted by Akeso\n\n\nIvonescimab Is the First Drug to Achieve Clinically Meaningful Benefit over Pembrolizumab in Randomized Phase III Clinical Trial in NSCLC\n\n\nAdditionally, Ivonescimab Phase II Data in Perioperative Setting for Resectable NSCLC to be Presented\n\n\n MIAMI--(BUSINESS WIRE)--\nSummit Therapeutics Inc. (NASDAQ: SMMT) (\"Summit,\" \"we,\" or the \"Company\") today announced that the primary analysis of the Phase III HARMONi-2 trial featuring its novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented as part of the Presidential Symposium at the International Association for the Study of Lung Cancer’s (IASLC) 2024 World Conference on Lung Cancer (WCLC 2024) in San Diego, California. The presentation will take place on Sunday, September 8, 2024 at 8:37 am PT (11:37 am ET).\n\n\nHARMONi-2 evaluated monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression (PD-L1 TPS >1%). HARMONi-2 is a single region, multi-center, double-blinded Phase III study conducted in China sponsored by our collaboration partner, Akeso, Inc. (Akeso, HKEX Code: 9926.HK), with data generated and analyzed by Akeso.\n\n\nThere are no known Phase III clinical trials in NSCLC that have shown a statistically significant efficacy improvement compared to pembrolizumab in a head-to-head setting.\n\n\nOn May 30, 2024, Akeso announced that in HARMONi-2 ivonescimab monotherapy achieved a statistically significant improvement in the trial’s primary endpoint, progression-free survival (PFS), when compared to monotherapy pembrolizumab. The PFS benefit was demonstrated across clinical subgroups, including those with PD-L1 low expression (PD-L1 TPS 1-49%), PD-L1 high expression (PD-L1 TPS ≥50%), squamous and non-squamous histologies, as well as other high-risk patients.\n\n\nThe trial results will be presented by Dr. Caicun Zhou, Chief Physician and Director of the Department of Medical Oncology at Shanghai Pulmonary Hospital, Tongji University School of Medicine, and President-Elect of IASLC.\n\n\nA second presentation titled, “A Phase II Study of Perioperative I...