Back to news

Ivonescimab Plus Chemotherapy Demonstrates Overall Survival Superiority Compared to Durvalumab Plus Chemotherapy in First-Line Treatment of Patients with Advanced Biliary Tract Cancer in HARMONi-GI1 Study Conducted by Akeso in China

Business Wire•25/10/2026•11:52 ET
0

Key Highlights

  • ➤HARMONi-GI1: Ivonescimab plus chemotherapy cut death risk 25%; OS HR 0.75
  • ➤Median OS reached 14.9 months versus 12.1 months with durvalumab plus chemotherapy
  • ➤Median PFS reached 8.4 months versus 5.8 months; PFS HR 0.61
  • ➤ORR was 53.8% versus 32.5% for durvalumab plus chemotherapy
  • ➤U.S. registration-enabling BTC Phase II/III study expected to begin in Q4 2026

Expert Statements

Maky Zanganeh, President and Co-Chief Executive Officer of Summit

“HARMONi-GI1 marks an important milestone for patients with advanced biliary tract cancer and for the continued development of ivonescimab. This is the first known Phase III study in advanced biliary tract cancer to demonstrate overall survival superiority over an anti-PD-(L)1 therapy combined with chemotherapy. Moreover, as the first Phase III readout for ivonescimab beyond non-small cell lung cancer, the HARMONi-GI1 results further reinforce the potential of ivonescimab to deliver meaningful survival improvements across multiple tumor types and support our commitment to advancing its development for patients with cancers where significant unmet need remains.”

Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit

“These results represent another significant step in realizing the broad potential of ivonescimab to transform outcomes for patients facing some of the most difficult-to-treat cancers. Overall survival is the gold-standard measurement of benefit for patients, and the efficacy superiority and safety profile demonstrated in HARMONi-GI1 reinforces our conviction in ivonescimab and its innovative design. We look forward to building upon these findings through our planned registration-enabling Phase II / III study in biliary tract cancer in collaboration with ECOG-ACRIN, as we work to bring this investigational therapy to patients in the United States and beyond.”

Ivonescimab Plus Chemotherapy Demonstrates Overall Survival Superiority Compared to Durvalumab Plus Chemotherapy in First-Line Treatment of Patients with Advanced Biliary Tract Cancer in HARMONi-GI1 Study Conducted by Akeso in China

First Regimen to Achieve a Statistically Significant and Clinically Meaningful Overall Survival Benefit over an Anti-PD-(L)1 Antibody Combined with Chemotherapy in a Phase III Clinical Trial in BTC

Get started

Create a free account to read the full story.

Sign Up

Already have an account? Log in