Summit Therapeutics Inc. (NASDAQ:SMMT) partner Akeso Inc. on Wednesday released positive topline findings from its randomized Phase 3 HARMONi-GI1 clinical trial (or AK112-309).
The study evaluated ivonescimab paired with chemotherapy against durvalumab combined with chemotherapy as a first-line therapy for patients diagnosed with advanced biliary tract cancer.
Ivonescimab Demonstrates Superior Survival Endpoint
A pre-specified interim analysis revealed that the ivonescimab combination achieved statistically significant and clinically meaningful superiority in overall survival over the durvalumab combination.
This primary endpoint result highlights a notable outcome, as durvalumab combined with chemotherapy is currently the preferred first-line immunotherapy regimen recommended by international medical guidelines and recognized as the optimal standard of care.
Furthermore, the trial met its key secondary endpoints, including progression-free survival and objective response rate.
Akeso plans to share comprehensive safety and efficacy data from this initial readout at an upcoming medical congress and publish the complete findings within a peer-reviewed journal.
First Phase 3 Trial To Beat Gold Standard
The HARMONi-GI1 trial stands as the first Phase 3 study in biliary tract cancer to show a statistically significant positive overall survival outcome against the global gold standard of a PD-L1 monoclonal antibody paired with chemotherapy, marking a major milestone in treating this complex disease.
Akeso sponsored the single-region, multi-center trial in China, exclusively generating, managing, and analyzing all associated data.
Regulatory Status Across Global Markets
Ivonescimab is currently approved and commercially available in China for non-small cell lung cancer indications.
The therapeutic agent remains investigational and has not secured approval from regulatory authorities across Summit’s licensed territories, which encompass the U.S. and Europe.
SMMT Price Action: Summit Therapeutics shares were up 7.82% at $14.40 at the time of publication on Wednesday, according to Benzinga Pro data.
Photo by Piotr Swat via Shutterstock
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