Agenus has enrolled the first patient in the BATTMAN Phase III trial, assessing botensilimab (BOT) plus balstilimab (BAL) in refractory, unresectable microsatellite stable (MSS) or mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC).
The trial compares the immunotherapy combination with best supportive care in a patient group considered resistant to immunotherapy.
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It is being run as a co-operative group trial led by the Canadian Cancer Trials Group (CCTG) and will take place across Australia, Canada, France and New Zealand, with more than 100 participating sites.
Academic networks involved include the Canadian Cancer Trials Group, GI Cancer Trials, and France’s Partenariat de Recherche en Oncologie Digestive (PRODIGE) consortium, including FFCD, GERCOR, and Unicancer.
The randomised, controlled global Phase III registrational-enabling trial will enrol 830 patients and is intended to support potential regulatory submissions for BOT plus BAL in this treatment setting.
It is intended to evaluate the combination in a difficult-to-treat metastatic colorectal cancer population across the participating countries.
Agenus chief medical officer Dr Steven O’Day said: “Enrolment of the first patient in the BATTMAN study marks a key milestone for Agenus and the BOT+BAL programme. 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.”
The CCTG is a cancer clinical trials research co-operative that runs Phase I to Phase III studies of anti-cancer and supportive therapies in Canada and worldwide.
Based at Queen’s University, it has supported more than 700 studies involving 100,000 patients from 40 countries across six continents via a network of 20,000 investigators and trial staff.
