Ivonescimab monotherapy beats pembrolizumab on overall survival in HARMONi-2
Illustration (decorative, not data).Summary
HARMONi-2 (AK112-303) is a Phase 3 study conducted in China in first-line PD-L1-positive locally advanced or metastatic non-small cell lung cancer, directly comparing ivonescimab (a PD-1×VEGF bispecific) monotherapy with pembrolizumab monotherapy. The primary endpoint, PFS, had already been met (HR 0.51, 95% CI 0.38–0.69); this pre-specified analysis shows a statistically significant improvement in overall survival as well, but the press release did not give the OS hazard ratio. A PFS win with OS unknown had been the key question over whether PD-1×VEGF bispecifics can displace Keytruda. Note that these are single-region data; the US and European markets covered by Summit still need support from global studies.
Deal terms, as disclosed
Phase 3 OS secondary endpoint met with statistical significance.
Summary of public disclosures, not investment advice. Amounts are as announced; milestone payments are contingent and may never be paid.
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