Ivonescimab Plus Chemotherapy Shows Consistent, Favorable Overall Survival Results in Western and Asian Patients in Updated Analysis from Global Phase III HARMONi Study
Western Patients Achieved OS HR of 0.76, Consistent with Asian Patients in this Global Phase III Study
Summit Therapeutics Inc. (Nasdaq: SMMT) today announced results of an updated overall survival (OS) analysis from the global Phase III HARMONi clinical trial featuring the novel, potential first-in-class investigational bispecific antibody ivonescimab. Ivonescimab plus platinum-doublet chemotherapy in this trial continues to show a positive OS trend and a consistent efficacy and safety profile in Asian and western patients when compared to chemotherapy alone. The HARMONi study is evaluating ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with endothelial growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who were previously treated with a third-generation EGFR tyrosine kinase inhibitor (TKI). The study demonstrated a statistically significant benefit in the primary analysis for progression-free survival (PFS), one of the study’s two primary endpoints along with OS. Summit’s Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) is based on the results from the HARMONi trial and has a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.
