Summit Therapeutics Inc. 8K

Summit Therapeutics announced positive overall survival results from partner Akeso’s Phase III HARMONi-2 trial of ivonescimab versus pembrolizumab in PD‑L1–positive NSCLC, reinforcing the rationale for Summit’s global ivonescimab development program.

Summit Therapeutics Inc. reported that its partner Akeso Inc. presented updated overall survival data from the Phase III HARMONi-2 trial in China showing that ivonescimab monotherapy produced a statistically significant and clinically meaningful overall survival benefit versus pembrolizumab monotherapy in PD‑L1–positive advanced non-small cell lung cancer, including a 27% reduction in risk of death and an 8.2‑month improvement in median overall survival, with a manageable safety profile; these results further support Summit’s ongoing global Phase III HARMONi-7 and broader ivonescimab development program, while noting that ivonescimab is approved in China but remains investigational in Summit’s territories.

Filing Facts

CIK

1599298

Ticker

SMMT

Form

8K

Source Type

fda

Accession

0001599298-26-000078

Alert Tier

6