Updated HARMONi Analysis: Summit Therapeutics Reports Improved Overall Survival, with Western Patients Now Matching Asian Benefit

summarizeSummary

Updated overall survival data from the Phase III HARMONi trial show a hazard ratio of 0.76 for ivonescimab plus chemotherapy, with western patients now demonstrating the same benefit as Asian patients after longer follow-up. The results have been submitted to the FDA ahead of the November 14, 2026 PDUFA date.

check_boxKey Events · Product Development and Regulatory · SMMT

• Updated OS Analysis Shows Improved Hazard Ratio

  With the June 2026 data cutoff, the HARMONi trial shows a hazard ratio of 0.76 for overall survival in the full intention-to-treat population, improved from 0.79 in the primary analysis and 0.78 in September 2025.

• Western Patients Now Match Asian Benefit

  After median follow-up extended to 23.2 months (from 9.2 months in the primary analysis), the western subgroup hazard ratio improved to 0.76, consistent with the Asian subgroup and the full population.

• Data Submitted to FDA Ahead of PDUFA

  The updated results have been made available to the FDA; the PDUFA goal date for the ivonescimab BLA is November 14, 2026.

• Safety Profile Remains Consistent

  Ivonescimab continued to show an acceptable and manageable safety profile with no new safety signals in this analysis.

auto_awesomeAnalysis · SMMT · Life Sciences

The latest analysis reveals the overall survival hazard ratio improving to 0.76 for both the full population and the western subgroup, up from 0.79 in the primary analysis and 0.78 in September 2025. Critically, western patients—who had only 9.2 months median follow-up in the primary analysis—now show the same magnitude of benefit as Asian patients after 23.2 months of follow-up. This consistency across geographies strengthens the case for FDA approval, with the PDUFA date set for November 14, 2026. The data have been shared with the FDA, and more detailed results will be presented at an upcoming medical conference.