Akeso, Inc. 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.

This marks the 7th international registrational Phase II/III clinical trial for ivonescimab. Previously, the Phase III HARMONi-GI1 study conducted by Akeso in China, evaluating ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for patients with BTC, achieved a positive overall survival (OS) result that was both statistically significant and clinically meaningful.

"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," said lead investigator Deirdre J. Cohen, MD, MS, Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai, Director of the Gastrointestinal Oncology Program for the Mount Sinai Health System and Co-Director of the Center of Excellence for Pancreatic Cancer at the Mount Sinai Tisch Cancer Center. "EA2251 will explore a novel therapeutic approach in the front-line setting by evaluating ivonescimab with chemotherapy against current immunotherapy-based standards of care."

"We are delighted to see the global clinical development of ivonescimab further expand into the field of biliary tract cancer. 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," said Dr. 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."

"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," said Dr. 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."