Akeso’s ivonescimab combination delivers positive Phase III survival result in biliary cancer

Akeso Inc., partner to Summit Therapeutics Inc., said a pre-specified interim analysis of its randomized Phase III AK112-309/HARMONi-GI1 study found that ivonescimab plus chemotherapy delivered a statistically significant and clinically meaningful overall-survival benefit over durvalumab plus chemotherapy in first-line treatment of advanced biliary tract cancer. The trial also met key secondary endpoints, including progression-free survival and objective response rate. Durvalumab plus chemotherapy is the preferred first-line immunotherapy regimen recommended by international guidelines and regarded as the optimal standard of care, making HARMONi-GI1 the first Phase III biliary tract cancer study to report a statistically significant positive overall-survival result against that standard. Akeso plans to present detailed safety and efficacy data at an upcoming medical congress and publish the full findings in a peer-reviewed journal. Ivonescimab is approved and commercially available in China for non-small cell lung cancer, but remains investigational and unapproved in Summit’s licensed territories, including the United States and Europe. Summit shares were up 7.82% at $14.40 at the time of publication on Wednesday, according to Benzinga Pro.

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