Agenus, a leader in immuno-oncology, has enrolled the first patient in its landmark global phase 3 BATTMAN, marking a major milestone for the company’s botensilimab (BOT) and balstilimab (BAL) immunotherapy combination.
The study targets patients with refractory, unresectable microsatellite-stable (MSS)/mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC), a group long considered resistant to immunotherapy.
The trial, led by the Canadian Cancer Trials Group (CCTG), spans more than 100 sites across Canada, France, Australia, and New Zealand. It leverages cooperative networks including GI Cancer Trials in Australia and France’s PRODIGE consortium, enrolling roughly 830 patients in a registrational-enabling study. Early interest from physicians and sites—bolstered by Agenus’ named patient and French AAC access programs—suggests global enrollment will move quickly.
“Enrollment of the first patient in the BATTMAN study marks a key milestone for Agenus and the BOT+BAL program,” said Steven O’Day, Chief Medical Officer at 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.”
“Our collaboration with Agenus builds on years of cooperative-group research aimed at bringing immunotherapy benefits to patients with microsatellite-stable colorectal cancer—those historically left without effective options,” said Chris O’Callaghan, Senior Investigator, Canadian Cancer Trials Group.
“Earlier CCTG studies suggested that doublet immunotherapy could extend survival even in cold tumors, and the magnitude and durability of responses seen with botensilimab and balstilimab in earlier studies warrant their investigation in a phase 3 trial.”
“The enthusiasm among investigators has been remarkable—within days of Health Canada submission, leading centers across Canada moved to open the study. We’re eager to advance this global effort and potentially transform outcomes for patients who have exhausted all other treatments,” said Jonathan Loree, Study Chair.
