Summit reported updated HARMONi overall survival results showing a hazard ratio of 0.76 in the full population and western subgroup.
Key Highlights:
- Updated OS analysis (data cutoff June 2026) shows hazard ratio 0.76 in both the intent-to-treat population and western patients, consistent with Asian results.
- Western median follow-up increased to 23.2 months (Asian median follow-up 32.7 months), improving western subgroup HR over prior cuts.
- Ivonescimab plus chemotherapy maintained an acceptable, manageable safety profile with no new safety signals noted.
- Detailed data have been shared with the FDA and are planned for presentation at an upcoming medical conference ahead of the BLA PDUFA date November 14, 2026.
Original SEC Filing:
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