PD-(L)1xVEGF bispecifics get their first survival win — Courtesy of Akeso

Akeso’s ivonescimab, combined with chemo, reduced death risk by 26% in a China-only phase 3 trial (HARMONi-A) for EGFR-mutated NSCLC, marking the first overall survival win for a PD-(L)1xVEGF bispecific drug.

Why it matters: The result validates a promising drug class and could position ivonescimab as a strong contender in immuno-oncology, but Summit Therapeutics’ global trial of the same drug didn’t meet its primary endpoint, clouding its U.S. and EU prospects.

Backstory: Ivonescimab targets both PD-1 and VEGF pathways to trigger immune responses and reduce tumor blood supply. It showed a flat OS curve “tail,” suggesting lasting benefits. Akeso leads development in China, while Summit holds rights in the U.S., EU, Canada, and Japan.

Big picture: This modest OS win (16.8 vs. 14.1 months) is promising but not groundbreaking in a competitive field. Kelun-Biotech’s sacituzumab tirumotecan showed a 40% death risk reduction, without chemo, raising the bar for next-gen therapies in this indication.

Zoom in: Summit’s global HARMONi trial failed its OS endpoint due to immature Western data, with only a 16% OS benefit observed in Western patients at 13.7 months’ follow-up.

What’s next: Summit’s HARMONi-3 trial will now separately assess nonsquamous and squamous cancers vs. Keytruda-based regimens. Following up on this, Summit plans to file for FDA approval this year, betting on longer-term consistency. Akeso will also capitalize on its success and might combine ivonescimab with antibody-drug conjugates (ADCs) for broader tumor coverage.