Study Targets MSS and pMMR Cancer Cases
Agenus Inc. has announced the enrollment of the first patient in its global Phase 3 BATTMAN trial. This trial evaluates the efficacy of the BOT+BAL immunotherapy combination for treating metastatic colorectal cancer (mCRC). MSS and pMMR types of mCRC represent about 95% of these cancer cases, which are traditionally resistant to immunotherapy.
More than 100 research sites across Canada, France, Australia, and New Zealand are participating in the BATTMAN trial, led by the Canadian Cancer Trials Group (CCTG). The trial is supported by CCTG, GI Cancer Trials in Australia, and France’s Partenariat de Recherche en Oncologie Digestive (PRODIGE) consortium.
Dr. Steven O’Day, Chief Medical Officer at Agenus, remarked, “Enrollment of the first patient in the BATTMAN study marks a key milestone for Agenus and the BOT+BAL program.”
The trial is expected to enroll approximately 830 patients. It serves as the registrational-enabling study for the BOT+BAL combination. Swift global enrollment reflects high interest from investigators and patients worldwide.
International Study Collaboration
Confidence in the trial’s potential was expressed by Dr. Chris O’Callaghan, a senior investigator with the Canadian Cancer Trials Group. “Earlier CCTG studies suggested that doublet immunotherapy could extend survival even in cold tumors,” he said, supporting further investigation in this Phase 3 trial.
Colorectal cancer has become the leading cause of cancer-related death in adults under age 50. This study could redefine outcomes for patients who have exhausted other treatment options. The trial aims to bring immunotherapy benefits to patients with microsatellite-stable colorectal cancer, historically left without effective options.
Dr. Jonathan Loree, CO.33 Study Chair, highlighted the rapid response of Canadian health centers in opening the study shortly after the Health Canada submission. Enthusiasm among investigators has been remarkable, showcasing the global effort to transform treatment outcomes for these patients.
Last updated: 4 April 2026, 8:22 pm
