Akeso Announces Summit Therapeutics and ECOG-ACRIN Cancer Research Group Enter into Phase II/III Clinical Trial Collaboration to Evaluate Ivonescimab in First-Line Biliary Tract Cancer
Key Highlights
- ➤EA2251 Phase II/III trial evaluates ivonescimab plus chemotherapy in first-line biliary tract cancer
- ➤Summit Therapeutics and ECOG-ACRIN entered a registration-enabling clinical trial collaboration
- ➤U.S. clinical trial site activations are expected to begin in Q4 2026
- ➤HARMONi-GI1 delivered statistically significant, clinically meaningful overall survival results
- ➤Ivonescimab rights deal carries total potential value of up to US$5 billion
Expert Statements
Deirdre J. Cohen, Lead investigator; Associate Professor of Medicine, Icahn School of Medicine at Mount Sinai
“Biliary tract cancer is often diagnosed at an advanced stage, and despite recent progress, there is a need for more effective first-line options that can extend survival and improve disease control.”
Deirdre J. Cohen, Lead investigator; Associate Professor of Medicine, Icahn School of Medicine at Mount Sinai
“EA2251 will explore a novel therapeutic approach in the front-line setting by evaluating ivonescimab with chemotherapy against current immunotherapy-based standards of care.”
Michelle Xia, Founder, Chairwoman, President and Chief Executive Officer of Akeso
“We are delighted to see the global clinical development of ivonescimab further expand into the field of biliary tract cancer.”
Michelle Xia, Founder, Chairwoman, President and Chief Executive Officer of Akeso
“Against the background of the positive OS results from the Phase III HARMONi-GI1 study of ivonescimab plus chemotherapy versus durvalumab plus chemotherapy, the advancement of the Phase III EA2251 study by a leading cooperative oncology group in the United States further strengthens our confidence in achieving global success.”
Michelle Xia, Founder, Chairwoman, President and Chief Executive Officer of Akeso
“We look forward to the progress of ivonescimab's registrational clinical development worldwide and its potential to become a superior treatment option for patients with biliary tract cancer globally as early as possible.”
Maky Zanganeh, President and Co-Chief Executive Officer of Summit Therapeutics
“We are honored to collaborate with ECOG-ACRIN on EA2251 as we continue to expand the development program for ivonescimab in areas of meaningful unmet need.”
Maky Zanganeh, President and Co-Chief Executive Officer of Summit Therapeutics
“The sponsorship and conduct of this registration-enabling study by a leading cooperative oncology group underscores the scientific interest in evaluating ivonescimab in difficult-to-treat cancers, including BTC, and supports Summit's commitment to building a robust body of clinical evidence across multiple tumor types and treatment settings.”
Akeso Announces Summit Therapeutics and ECOG-ACRIN Cancer Research Group Enter into Phase II/III Clinical Trial Collaboration to Evaluate Ivonescimab in First-Line Biliary Tract Cancer PR Newswire
* Becomes the 7th International Registrational Clinical Trial for Ivonescimab * Clinical Trial Site Activations in the United States Expected to Begin Q4 2026 HONG KONG, Oct. 21, 2026 /PRNewswire/ -- Akeso, Inc. (HKEX: 9926.HK) today announced that Summit Therapeutics Inc. (NASDAQ: SMMT), its global partner for ivonescimab, has entered into a clinical trial collaboration with the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) to evaluate ivonescimab in a registration-enabling Phase II/III study in biliary tract cancer (BTC). The new study, EA2251 (NCT07765433), is designed to evaluate the safety and efficacy of ivonescimab with chemotherapy compared to pembrolizumab or durvalumab plus chemotherapy in the first-line treatment of patients with advanced BTC.
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