Summit and Akeso's ivonescimab beats Merck's Keytruda in Chinese NSCLC trial

Summit Therapeutics and Akeso reported that their bispecific PD-1/VEGF antibody ivonescimab outperformed Merck's Keytruda in a Phase 3 HARMONi-2 trial conducted in China. The study enrolled first‑line non‑small cell lung cancer patients whose tumors express PD‑L1 and showed improvements in both overall survival and progression‑free survival for ivonescimab.

Ivonescimab is already approved in China for this indication and two other cancers, but it has not yet received U.S. regulatory clearance. The companies said the data must be replicated in Western patients before the FDA will consider a review.

Analysts noted that the positive readout could establish a new treatment paradigm for NSCLC if the results are confirmed outside China, although regulatory approval remains pending.