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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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