eClinical Technology and Industry News

Agenus Announces First Patient Enrolled in Global Phase 3 BATTMAN Trial of BOT+BAL Immunotherapy Combination in MSS or pMMR Metastatic Colorectal Cancer

  • A Landmark Registrational Study Aiming to Redefine Outcomes in MSS mCRC Which Represents Approximately 95% of Metastatic Colorectal Cancer Cases
  • Colorectal Cancer Has Become the Leading Cause of Cancer-related Death in Adults Under Age 50

Excerpt from the Press Release:

LEXINGTON, Mass.–(BUSINESS WIRE)–Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced that the first patient has been enrolled in the landmark global phase 3 BATTMAN (CO.33) trial (NCT07152821). This study is evaluating Agenus’ immunotherapy combination of botensilimab (BOT) plus balstilimab (BAL) versus best supportive care in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC), a population long considered resistant to immunotherapy.

This study is being conducted as a cooperative group trial led by the Canadian Cancer Trials Group (CCTG) from Canada and run across Canada, France, Australia and New Zealand. More than 100 sites will participate across the academic cooperative networks of CCTG, GI Cancer Trials in Australia and France’s Partenariat de Recherche en Oncologie Digestive (PRODIGE) consortium (including Unicancer, GERCOR and FFCD). The BATTMAN (CO.33) trial serves as the registrational-enabling study for BOT+BAL enrolling approximately 830 patients and is expected to complete global enrollment quickly, reflecting the unprecedented investigator and patient enthusiasm worldwide, including strong interest from sites and physicians engaged through Agenus’ paid named patient and French AAC access programs.

“Enrollment of the first patient in the BATTMAN study marks a key milestone for Agenus and the BOT+BAL program,” said Dr. Steven O’Day, Chief Medical Officer, Agenus. “This study advances our goal of developing effective immunotherapies for patients who currently have few options. We’re grateful to our partners at CCTG, GI Cancer Trials in Australia, and PRODIGE and to the dedicated investigators, site staff, and patients driving this global effort.”

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