FDA Grants Fast Track Designation for Ivonescimab in 2L+ EGFRm NSCLC
HARMONi Completed Enrollment for Summit's First Sponsored Study Evaluating Ivonescimab
Topline data from the HARMONi Trial Is Expected in Mid-2025
Summit Therapeutics Inc. (NASDAQ:SMMT) ("Summit," "we," or the "Company") today announced that we have completed enrollment in our HARMONi clinical trial, a multi-regional Phase III study sponsored by Summit evaluating ivonescimab plus platinum-doublet chemotherapy vs. placebo plus platinum-doublet chemotherapy with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with a 3rd generation EGFR tyrosine kinase inhibitor (TKI). HARMONi completed enrolling patients from sites in North America, Europe, and China. This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials.