康方生物合作方公布依沃西单抗一项全球Ⅲ期研究结果：总生存期未达到统计学显著差异

Core Insights - Summit Therapeutics announced the topline results of the global Phase III clinical trial HARMONi for ivonescimab, a PD-1/VEGF dual antibody developed by Innovent Biologics [1][2] - The trial aimed to evaluate the efficacy of ivonescimab combined with chemotherapy versus placebo combined with chemotherapy in patients with locally advanced or metastatic non-squamous non-small cell lung cancer harboring EGFR mutations [1] Group 1: Clinical Trial Results - The results showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) with a hazard ratio of 0.52 (95% CI: 0.41–0.66; p<0.00001) for ivonescimab combined with chemotherapy compared to chemotherapy alone [2] - Although the overall survival (OS) data showed a positive trend, it did not reach statistical significance, with a hazard ratio of 0.79 (95% CI: 0.62–1.01; p=0.057) [2] - Summit plans to use the HARMONi trial data to submit a Biologics License Application to the U.S. Food and Drug Administration [2] Group 2: Market Reaction - The results were consistent with the HARMONi-A trial conducted by Innovent Biologics in China [2] - Following the announcement of the data, Summit's stock price experienced a significant decline on May 30 [2]