Why Is Summit Therapeutics Stock Trading Higher On Monday?

Core Viewpoint - Summit Therapeutics Inc. experienced a significant stock decline of nearly 30% following the announcement that Akeso, Inc.'s ivonescimab received approval for a second indication from Chinese Health Authorities based on Phase 3 trial results [1]. Group 1: Clinical Trial Results - The HARMONi-2 trial evaluated ivonescimab, a PD-1/VEGF bispecific antibody, against Merck's Keytruda in patients with advanced non-small cell lung cancer (NSCLC) with positive PD-L1 expression [2]. - The interim analysis of overall survival (OS) showed a clinically meaningful hazard ratio of 0.777, conducted at 39% data maturity with a nominal alpha level of 0.0001 [4]. - The primary analysis for HARMONi-2 demonstrated a statistically significant improvement in progression-free survival (PFS) with a hazard ratio of 0.51 (p<0.0001) when compared to pembrolizumab [5]. Group 2: Ongoing and Future Trials - Summit is currently enrolling patients in the HARMONi-7 Phase 3 clinical trial, which is evaluating ivonescimab monotherapy against pembrolizumab in patients with advanced NSCLC with positive PD-L1 expression [6]. - HARMONi-7 is being conducted globally with registrational intent for the U.S. and other regions within Summit's license territories [7]. - The HARMONi-6 trial evaluated ivonescimab in combination with platinum-based chemotherapy against tislelizumab, meeting its primary endpoint of PFS [8]. Group 3: Market Reactions - Following the developments regarding ivonescimab, BioNTech SE's stock also saw an increase, indicating positive market sentiment towards bispecific antibody candidates in oncology [9].