Agenus made the following post on LinkedIn:
“A significant milestone for Agenus and the BOT+BAL program.
The first patient has enrolled in our global Phase 3 BATTMAN (CO.33) trial evaluating botensilimab + balstilimab in refractory MSS/pMMR metastatic colorectal cancer — a population that has historically not benefited from immunotherapy.
This registrational study spans more than 100 sites across Canada, France, Australia, and New Zealand, reflecting the urgency to bring new options to patients.
Read the full announcement.”
This marks an important step for the company’s immuno-oncology program, as the BATTMAN trial is designed to evaluate botensilimab plus balstilimab versus best supportive care in patients with refractory, unresectable MSS/pMMR metastatic colorectal cancer, a setting where immunotherapy has historically shown limited benefit.
According to Agenus, the registrational Phase 3 study will run across more than 100 sites in Canada, France, Australia, and New Zealand, with the trial expected to enroll approximately 830 patients. The study is being led by the Canadian Cancer Trials Group (CCTG) in collaboration with cooperative research networks in Australia and France.
The BATTMAN trial is a key part of Agenus’ broader strategy to advance its BOT+BAL combination in difficult-to-treat cancers. The program has drawn attention following previously reported data showing encouraging survival outcomes in heavily pretreated MSS metastatic colorectal cancer, helping set the stage for this global Phase 3 effort.
For Agenus, this first-patient-enrolled milestone signals growing momentum behind a program aimed at addressing one of the largest unmet needs in colorectal cancer treatment.
You can read further on BOT+BAL combination in MSS metastatic colorectal cancer on OncoDaily.