Summit Therapeutics reports positive Phase 3 data for lung cancer drug ivonescimab, highlighting regulatory hurdles for US approval

Summit Therapeutics and its Chinese partner Akeso announced that their PD-1/VEGF antibody ivonescimab showed positive results in a Phase 3 trial for non-small cell lung cancer in Western patients.

The data suggest the drug’s efficacy can be reproduced across regions, an important step for cancer assets that originate in China but aim for U.S. market approval.

Analysts note that despite the encouraging results, the company will still need to satisfy the FDA, which often requires additional bridging studies or global trial data, similar to how Merck handled its Keytruda program.

The discussion underscores a shifting landscape where Chinese‑originated therapies must prove themselves in Western trials before gaining regulatory clearance in the United States.