Ivonescimab Plus Chemotherapy Demonstrates Significant Overall Survival Benefit Versus Durvalumab Plus Chemotherapy in First-Line Biliary Tract Cancer: HARMONi-GI1 Meets Primary Endpoint

On August 25, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that a pre-specified interim analysis assessed by the Independent Data Monitoring Committee (IDMC) of the randomized, controlled, double-blinded, multicenter, registrational Phase III clinical study (AK112-309/HARMONi-GI1) of ivonescimab in combination with chemotherapy versus durvalumab (PD-L1 monoclonal antibody) in combination with chemotherapy for the first-line treatment of advanced biliary tract cancer (BTC), showed that the study met its primary endpoint of overall survival (OS), achieving a clinically meaningful and statistically significant positive result. The study also met all key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR).

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Detailed results from this study will be presented at an upcoming international academic conference and published in a peer-reviewed journal.

Durvalumab in combination with chemotherapy is currently the preferred first-line immunotherapy regimen recommended by international guidelines and is regarded as the optimal standard of care (SOC). HARMONi-GI1 is the first Phase III study in biliary tract cancer to demonstrate a statistically significant positive OS result versus the global gold standard (PD-L1 monoclonal antibody plus chemotherapy), representing a major milestone in the treatment of this difficult disease.

Dr. Michelle Xia, Founder, Chairwoman, President and CEO of Akeso:
"We are delighted the Phase III clinical study of ivonescimab in combination with chemotherapy versus durvalumab in combination with chemotherapy for the first-line treatment of biliary tract cancer has achieved a statistically significant positive OS result. This is a major breakthrough for the treatment of biliary tract cancer.

"We sincerely thank the investigators, study teams, and patients who made HARMONi-GI1 possible. Their important contributions bring us closer to an innovative, safe, and highly effective new treatment option against this aggressive cancer.

"The positive result of HARMONi-GI1 marks the first positive Phase III study for ivonescimab in gastrointestinal tumors, following four positive Phase III results in lung cancer. The breakthrough clinical value of ivonescimab is now expanding from lung cancer to a broader range of solid tumors. We look forward to making this innovative therapy available to patients worldwide as soon as possible."

(Press release, Akeso Biopharma, AUG 25, 2026, View Source [SID1234670329])