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Agenus Initiates Botensilimab Phase 2 ACTIVATE Trials in Advanced MSS Colorectal Cancer and Advanced Melanoma
Phase 2 ACTIVATE trials to advance globally in metastatic patients who have progressed on available therapiesBotensilimab, alone and in combination with
About this update from Agenus Inc.
[{"type":"text","content":"Phase 2 ACTIVATE trials to advance globally in metastatic patients who have progressed on available therapiesBotensilimab, alone and in combination with balstilimab (PD-1), has demonstrated robust clinical activity in nine treatment-resistant tumor types, including microsatellite stable colorectal cancer LEXINGTON, Mass., Sept. 12, 2022 (GLOBE NEWSWIRE) -- Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, today announced the initiation of a global Phase 2 program of botensilimab, an Fc-enhanced anti-CTLA-4 that activates innate and adaptive immune responses. These trials include ACTIVATE-Colorectal, a Phase 2 study designed to evaluate botensilimab as monotherapy and in combination with balstilimab (anti-PD-1) for the treatment of microsatellite stable colorectal cancer (MSS CRC), and ACTIVATE-Melanoma, a Phase 2 study designed to evaluate botensilimab as a single agent for advanced melanoma, refractory to either prior anti-PD-1 or combined anti-PD-1/anti-CTLA-4 therapy. An additional Phase 2 study in pancreatic cancer is anticipated to begin later in 2022. “The Phase 1 botensilimab program demonstrated remarkable activity in poorly immunogenic and difficult to treat tumor types,” said Steven O’Day, MD, Chief Medical Officer at Agenus. “In light of our compelling clinical data, we have received clearance from the FDA to initiate our Phase 2 development program in two indications and intend to expand to multiple additional indications as rapidly as possible with the aim of delivering a transformative new treatment option to patients in need.” ACTIVATE-Colorectal is a global, randomized, open-label, dose-optimization study evaluating the safety and efficacy of botensilimab as monotherapy and in combination with balstilimab in advanced refractory MSS CRC patients. Key elements of ACTIVATE-Colorectal include: Patients must have received at least one prior chemotherapy regimenPatients cannot have received prior PD-1, CTLA-4 or other immune checkpoint inhibitor therapyPrimary endpoint is overall response rate (ORR); secondary endpoints include duration of response (DOR), progression-free survival (PFS) and overall survival (OS)Recruitment will be global, including sites in the United States and Europe ACTIVATE-Melanoma is a g...