Chinese biopharmaceutical company Akeso Inc (HKEX:9926) announced on Sunday the presentation of results from the randomised, controlled, double-blind, multicentre, registrational Phase III HARMONi-GI1 trial (AK112-309).

The study evaluated first-in-class ivonescimab plus chemotherapy versus durvalumab (PD-L1) plus chemotherapy as first-line treatment for patients with advanced biliary tract cancer (BTC) and was presented at the 2026 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain.

In a prespecified interim analysis reviewed by the Independent Data Monitoring Committee (IDMC), HARMONi-GI1 met its primary endpoint of overall survival (OS), with the ivonescimab plus chemotherapy arm demonstrating statistically significant and clinically meaningful improvement over the control arm. The trial also met all key secondary endpoints, including progression-free survival (PFS) and objective response rate (ORR).

According to Akeso, HARMONi-GI1 is the first Phase III trial in biliary tract cancer to demonstrate statistically significant and clinically meaningful positive results in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) versus this standard of care regimen (PD-L1 monoclonal antibody plus chemotherapy), marking a major milestone in the treatment of this challenging disease.

Results showed that, compared with durvalumab plus chemotherapy, first-line treatment with ivonescimab plus chemotherapy significantly prolonged overall survival in patients with BTC, meeting the prespecified threshold for statistical significance and delivering clinically meaningful benefit. Prespecified subgroup analyses showed a generally consistent trend of OS benefit.