Summit Therapeutics Said That Based On HARMONi Trial Data, It Plans To Submit A Biologics License Application For Ivonescimab Plus Chemotherapy For Epidermal Growth Factor Receptor-mutant Non-small Cell Lung Cancer In Q4 Of 2025

Author: Benzinga Newsdesk | October 20, 2025 05:48am

• Summit Plans to Submit a BLA in Q4 2025 for Ivonescimab Based on HARMONi Global Phase III Study Results
• Expansion of Summit's Global Phase III Development Program Starts with Initiation of HARMONi-GI3, a New Study in 1L CRC: Summit to Initiate an Additional Set of Phase III Clinical Trials with Details to Come in Q1 2026
• Ivonescimab with Chemotherapy Reduces the Risk of Disease Progression or Death by 48% Compared to Chemotherapy Alone in Global Phase III HARMONi Trial Evaluating Patients with EGFRm NSCLC after EGFR TKI Therapy with Consistent Data across Regions
• Ivonescimab with Chemotherapy Reduced the Risk of Disease Progression or Death by 40%, Median PFS of 11.14 Months, Compared to Tislelizumab (PD-1 Inhibitor) Plus Chemotherapy, Median PFS 6.90 Months, in 1L Treatment of Patients with Squamous NSCLC in Phase III HARMONi-6 Study Conducted by Akeso in China
• HARMONi-3 Global Phase III Study Analyses Will Be Split by Histology: Squamous NSCLC Cohort Expected to Complete Enrollment First Half of 2026 with Data Readout Expected Second Half 2026; Non-Squamous NSCLC Cohort Expected to Complete Enrollment Second Half of 2026

Posted In: SMMT