AKESO(09926) 智通财经网·2025-05-30 12:37Core Insights - Summit Therapeutics announced that its main asset ivonescimab, developed in collaboration with Chinese partner Kangfang Biopharma, achieved its primary endpoint in a clinical trial for lung cancer treatment [1][2] - The phase 3 HARMONi trial demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) when ivonescimab was combined with chemotherapy, although the overall survival (OS) did not show statistically significant differences [1] - The trial focused on patients with locally advanced or metastatic non-squamous non-small cell lung cancer harboring epidermal growth factor receptor (EGFR) mutations, who are resistant to third-generation EGFR tyrosine kinase inhibitors [1] Trial Results - The HARMONi trial showed that approximately 57% of patients receiving ivonescimab plus chemotherapy experienced grade 3 or higher treatment-related adverse events, compared to about 50% in the control group [1] - The results align with the HARMONi-A trial conducted in China, which led to the approval of ivonescimab combined with chemotherapy for lung cancer treatment by Chinese regulatory authorities [2] Regulatory Plans - Summit plans to utilize the HARMONi trial data to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of ivonescimab in combination with chemotherapy for the specified lung cancer patient population [2] Market Reaction - Following the announcement, Summit's stock experienced volatility, initially rising over 16% before dropping more than 12% in pre-market trading [3]