Summit Therapeutics Inc. (NASDAQ: SMMT) announced positive results from a longer-term follow-up analysis of its Phase III HARMONi clinical trial, evaluating ivonescimab, a novel bispecific antibody, in combination with chemotherapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
The updated analysis, presented at the International Association for the Study of Lung Cancer’s (IASLC) 2025 World Conference on Lung Cancer (WCLC 2025) in Barcelona, Spain, focused on extending the follow-up period for Western patients. This extended follow-up showed a statistically significant improvement in overall survival (OS) compared to chemotherapy alone.
Initially, the primary analysis of OS in the HARMONi trial showed a positive trend but did not reach statistical significance. However, the longer follow-up period revealed a more substantial benefit. The median OS remained consistent with the primary analysis, but the hazard ratio improved, achieving a statistically significant p-value.
The improvement was particularly pronounced in North American patients, where the hazard ratio was notably lower than in the overall Western patient population and the Asian patient population. The study also demonstrated a consistent benefit across various subgroups.
Dr. Jonathan Goldman of UCLA presented the data, highlighting the clinically meaningful efficacy of ivonescimab in combination with chemotherapy. He emphasized the impact of the longer follow-up period in clarifying the treatment’s benefit.
Robert W. Duggan, Summit‘s Chairman and Co-Chief Executive Officer, expressed satisfaction with the results, emphasizing the global applicability of ivonescimab and the collaboration with the U.S. Food and Drug Administration (FDA) that allowed for the expanded multi-regional trial.
Dr. Maky Zanganeh, Summit‘s President and Co-Chief Executive Officer, expressed gratitude to all participants involved in the trial, highlighting the importance of such studies in advancing cancer therapies. He also pointed to upcoming data from the HARMONi-2 and HARMONi-6 trials as further catalysts for ivonescimab‘s potential.
The safety profile of ivonescimab plus chemotherapy remained consistent with previous studies, showing an acceptable and manageable safety profile with no new safety signals identified. The most common adverse events were similar to those expected with chemotherapy.
Ivonescimab is a novel bispecific antibody designed to combine immunotherapy and anti-angiogenesis effects into a single molecule. Its unique design aims to improve upon the efficacy and safety profiles of existing t
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