FDA Accepts SMMT's Application Seeking Approval for NSCLC Drug

Core Insights - Summit Therapeutics (SMMT) announced that the FDA has accepted its biologics license application (BLA) for ivonescimab plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) [2] - The FDA has set a target action date of November 14, 2026, for the BLA [2] - The BLA submission is based on data from the phase III HARMONi study, which evaluated ivonescimab plus platinum-doublet chemotherapy versus placebo plus platinum-doublet chemotherapy [5] - The study met one of its two primary endpoints—progression-free survival (PFS)—but did not meet the overall survival (OS) endpoint, although there was a favorable trend toward OS [6] Company Developments - Ivonescimab is a first-in-class bispecific antibody targeting PD-1 and VEGF, developed in collaboration with China-based Akeso [7] - Summit is conducting three late-stage studies (HARMONi, HARMONi-3, and HARMONi-7) to evaluate ivonescimab for NSCLC [8] - The company has expanded ivonescimab's development to include a phase III HARMONi-GI3 study for unresectable metastatic colorectal cancer, with enrollment initiated in late 2025 [9] - Summit plans to provide more details on additional late-stage studies in the first quarter of 2026 [10] Market Performance - Over the past year, shares of Summit have declined by 28.4%, while the industry has seen a smaller decline of 1.3% [3] - Summit currently holds a Zacks Rank 3 (Hold), with better-ranked stocks in the biotech sector including Assertio Holdings (ASRT), Alkermes (ALKS), and Soleno Therapeutics (SLNO), each with a Zacks Rank 1 (Strong Buy) [11]