An ivonescimab trial planned by Summit Therapeutics and the ECOG-ACRIN Cancer Research Group will test whether the investigational antibody plus chemotherapy can improve survival in advanced biliary tract cancer. Announced on October 21, 2026, the U.S. Phase II/III study is designed to generate evidence that could support a regulatory submission, with clinical-site activation expected in the fourth quarter of 2026.
Key Takeaways
- EA2251 will compare ivonescimab plus chemotherapy with established first-line immunotherapy and chemotherapy combinations.
- Summit will supply the drug and provide financial support for the National Cancer Institute-funded study.
- The U.S. study follows a reported survival benefit in a separate Akeso-sponsored trial in China.
Table of Contents
- Ivonescimab trial will test against current treatment
- Summit supplies the drug as national network leads execution
- China study provides rationale, not U.S. results
- Conclusion
Ivonescimab trial will test against current treatment
The EA2251 trial announcement describes a randomized study comparing ivonescimab plus gemcitabine and cisplatin with either pembrolizumab or durvalumab combined with the same chemotherapy. Using the same chemotherapy backbone allows the study to assess the ivonescimab-based regimen against current first-line treatment.
The open-label trial will enroll patients in the United States and use overall survival as its primary endpoint. It is registration-enabling, meaning its evidence could support an application to the U.S. Food and Drug Administration; the announcement is not an approval or a report of results.
Ivonescimab targets both PD-1 and VEGF, combining an immunotherapy mechanism with an approach intended to inhibit blood-vessel formation. The drug is not approved in the United States.
| Item | Details |
|---|---|
| Secondary efficacy measures | Progression-free survival and objective response rate |
| Response durability | Duration of response |
| Additional disease measure | Disease control rate |
| Tolerability assessment | Safety |
Summit supplies the drug as national network leads execution
The National Cancer Institute, part of the U.S. National Institutes of Health, is funding EA2251. Summit will supply ivonescimab and provide financial support under its collaboration agreement with ECOG-ACRIN.
ECOG-ACRIN will conduct the study through the NCI’s National Clinical Trials Network, with participation from Alliance for Clinical Trials in Oncology, NRG Oncology and SWOG Cancer Research Network. The collaboration is intended to support recruitment across a broad U.S. clinical-site network for a rare cancer.
For Summit, which is developing ivonescimab through a partnership with its inventor, Akeso, the agreement adds a cooperative-group study to the drug’s development program. Site activation remains an expected milestone rather than a completed step.
China study provides rationale, not U.S. results
In August 2026, Akeso reported that ivonescimab plus chemotherapy improved overall survival against durvalumab plus chemotherapy at a prespecified interim analysis of HARMONi-GI1, a separate Phase III trial conducted in China. Akeso also reported that the study met its key secondary endpoints for progression-free survival and objective response rate.
Those findings provide the rationale for EA2251, but do not establish the outcome of the planned U.S. trial. Detailed HARMONi-GI1 results are scheduled for presentation on October 25 at the European Society for Medical Oncology 2026 Congress.
Biliary tract cancers include gallbladder cancer and cancers arising in the bile ducts. They are often diagnosed after spreading, and ECOG-ACRIN said better treatment options are needed despite advances from adding immunotherapy to chemotherapy.
Conclusion
The next scheduled development is the October 25 presentation of detailed HARMONi-GI1 results, followed by expected U.S. site activation in the fourth quarter of 2026. EA2251 will then test whether the reported benefit in China can translate into improved survival against current treatment in a U.S. population.
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