HARMONi-3
The global test of whether ivonescimab plus chemotherapy beats the Keytruda-chemotherapy standard. An interim look in May 2026 fell short on progression; final results are due later in 2026.
Interim analysis (May 2026) did not reach statistical significance for PFS; the company expects final PFS and interim OS readouts in 2026. The FDA has set a PDUFA date of 14 November 2026 for a separate BLA based on HARMONi (EGFR-mutant, post-TKI), where the Western-subgroup OS hazard ratio improved to 0.76 without statistical significance.
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