Summit Therapeutics Inc. 8K

Summit Therapeutics reported that partner Akeso’s Phase III HARMONi-GI1 trial in China showed ivonescimab plus chemotherapy significantly improved overall survival versus durvalumab plus chemotherapy in first-line advanced biliary tract cancer, with key secondary endpoints also met.

On August 25, 2026, Summit Therapeutics Inc. announced that its partner Akeso Inc. reported positive topline results from the randomized Phase III HARMONi-GI1 trial conducted in China, in which ivonescimab plus chemotherapy achieved statistically significant and clinically meaningful superiority in overall survival compared to durvalumab plus chemotherapy as first-line treatment for patients with advanced biliary tract cancer, and also met key secondary endpoints of progression-free survival and objective response rate; the data, generated and managed exclusively by Akeso, represent the first known Phase III study in advanced biliary tract cancer to demonstrate overall survival superiority versus an anti-PD-(L)1 plus chemotherapy regimen and mark the first Phase III readout for ivonescimab beyond non-small cell lung cancer, while ivonescimab remains investigational and unapproved in Summit’s license territories.

Filing Facts

CIK

1599298

Ticker

SMMT

Form

8K

Source Type

fda

Accession

0001599298-26-000074

Alert Tier

6