Agenus receives Fast Track Designation from FDA for botensilimab, balstilimab

Agenus has been granted Fast Track Designation from the FDA for the investigation of the combination of botensilimab and balstilimab. The designation is for patients with non-microsatellite instability-high/deficient mismatch repair metastatic colorectal cancer with no active liver involvement. Patients targeted with this designation are heavily pretreated are resistant or intolerant to a fluoropyrimidine, oxaliplatin, and irinotecan, and who have also received a VEGF inhibitor, an EGFR inhibitor and/or a BRAF inhibitor, if indicated. The company is conducting a global, randomized Phase 2 trial of botensilimab in combination with balstilimab compared to standard of care in non-microsatellite instability-high colorectal cancer patients.