Ivonescimab Beats Keytruda on Survival in Phase 3 NSCLC Trial
- Ivonescimab (Akeso/Summit's PD-1 x VEGF bispecific) reduced risk of death by 27% vs. Merck's Keytruda in the Phase 3 HARMONi-2 trial.
- Trial enrolled treatment-naive, PD-L1-positive advanced NSCLC patients in China.
- Median overall survival: 30.75 months for ivonescimab vs. 22.57 months for Keytruda.
- Adds to the trial's earlier primary PFS win — a 49% reduction in progression/death risk (11.14 vs. 5.82 months).
- Fourth Phase 3 ivonescimab readout to hit its OS endpoint, bolstering the case for combining PD-1 blockade with anti-VEGF activity in one bispecific.
- Akeso (China) and Summit Therapeutics (ex-China licensee) are co-developing the drug as a head-to-head Keytruda challenger.
A head-to-head overall-survival win over Keytruda is about as rare an event as oncology drug development produces — Merck's franchise has fended off nearly every direct challenger for a decade, and ivonescimab is now four-for-four on OS across its Phase 3 program. That changes the calculus for Summit, whose ex-China license from Akeso looked speculative at signing and now looks like one of the shrewder biotech deals in recent memory — every data cut adds leverage for future pricing, partnering, or M&A conversations. It's also the clearest advertisement yet for the China-originated-asset licensing wave Western biotechs have been chasing: a domestically-developed bispecific outrunning the world's best-selling drug in its own trial. For Merck, it lands squarely as Keytruda nears patent cliff — this isn't a niche subtype win, it's a direct share threat in frontline NSCLC, the franchise's core indication.
Akeso details survival win for its PD-1xVEGF drug versus Keytruda ↗