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
Business Wire•21/10/2026•06:05 ET
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Key Highlights
- ➤EA2251 launches registration-enabling Phase II/III trial in first-line advanced biliary tract cancer
- ➤Ivonescimab plus chemotherapy will be compared against pembrolizumab or durvalumab chemotherapy regimens
- ➤U.S. clinical trial site activations are expected to begin in Q4 2026
- ➤HARMONi-GI1 achieved statistically significant, clinically meaningful overall-survival superiority in BTC
- ➤Summit’s HARMONi ivonescimab study supported FDA-accepted BLA with November 14, 2026 PDUFA date
Expert Statements
Deirdre J. Cohen, Lead investigator; Associate Professor of Medicine at the 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 at the 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.”
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.”
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
Clinical Trial Site Activations in the United States Expected to Begin Q4 2026
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