Ivonescimab’s Keytruda win raises the stakes for regulatory review and global adoption

Akeso and Summit reported that ivonescimab delivered a statistically significant overall-survival improvement over Keytruda in the phase 3 HARMONi-2 trial in previously untreated, PD-L1-positive non-small-cell lung cancer patients in China.

The result follows earlier HARMONi-2 data showing median progression-free survival of 11.14 months with ivonescimab versus 5.82 months with Keytruda, corresponding to a 49% reduction in the risk of progression or death.

The companies said HARMONi-2 is the fourth phase 3 ivonescimab trial to meet its overall-survival endpoint, strengthening the case that the drug’s PD-1 and VEGF-A mechanism may outperform PD-1 blockade alone in selected lung-cancer settings.

The immediate next steps are detailed data disclosure at a medical meeting, regulatory submissions or label expansion in China, and continued U.S. regulatory review. Summit’s first U.S. application, for ivonescimab plus chemotherapy in previously treated EGFR-mutated non-squamous NSCLC, has an FDA target decision date of November 14, 2026.

The HARMONi-2 result is strategically important but does not automatically establish ivonescimab as a global replacement for Keytruda. The trial was conducted in Chinese patients, and regulators will assess the full survival data, safety profile, consistency across subgroups, manufacturing, and applicability to Western populations.

Investors should watch the final hazard ratio and median overall-survival figures, adverse events such as hypertension, bleeding and immune-related toxicities, details of the U.S. trials including HARMONi-3, and whether Merck responds with competing combination or next-generation immunotherapy data.