Agenus, in collaboration with the Canadian Cancer Trials Group (CCTG), is conducting a global phase 3 trial evaluating the immunotherapy combination of botensilimab (BOT) and balstilimab (BAL) versus best supportive care (BSC) in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) colorectal cancer. This registrational study will be conducted as an international cooperative group trial, led by CCTG and supported by academic networks including AGITG (Australasia) and PRODIGE (France), which comprises Unicancer, GERCOR, and FFCD. The trial will be conducted across more than 100 sites in Canada, France, Australia, and New Zealand. For more information on the study, visit the CCTG site here: https://www.ctg.queensu.ca/patients/colorectal-cancer-clinical-trial-co33

ROBBIN is a planned global, randomized, open-label Phase 3 study evaluating botensilimab plus balstilimab as neoadjuvant treatment for patients with previously untreated, resectable, high-risk Stage II or Stage III microsatellite-stable/mismatch repair-proficient colon cancer.

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Approximately 850 patients are expected to be randomized 1:1 to receive either:

Botensilimab plus balstilimab before surgery, followed by standard-of-care adjuvant chemotherapy or observation based on pathologic stage and clinical guidelines; or surgery followed by standard-of-care adjuvant chemotherapy or observation.

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The primary endpoint is event-free survival. Key secondary endpoints include overall survival, preservation of circulating tumor DNA clearance and quality of life. The study will also evaluate pathologic response, the relationship between pathologic response and longer-term outcomes, use of adjuvant chemotherapy and potential biomarkers.

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The ROBBIN study is planned and has not yet begun enrollment. Study details remain subject to final protocol completion and regulatory and ethics approvals.

This study is an open-label, 2-part, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab in participants with advanced cutaneous melanoma refractory to checkpoint inhibitor therapy.

This is an open-label, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab or standard-of-care treatments in participants with refractory metastatic colorectal cancer.