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Agenus Completes Enrollment in Randomized Phase 2 Clinical Trial of Botensilimab/Balstilimab in Advanced Colorectal Cancer
LEXINGTON, Mass.--(BUSINESS WIRE)-- Agenus Inc. (Nasdaq: AGEN), a leader in developing novel immunological agents to treat various cancers today announced
About this update from Agenus Inc.
[{"type":"text","content":" LEXINGTON, Mass.--(BUSINESS WIRE)--\nAgenus Inc. (Nasdaq: AGEN), a leader in developing novel immunological agents to treat various cancers today announced completion of the planned patient enrollment in ACTIVATE-Colorectal, a randomized Phase 2 trial in advanced colorectal cancer (CRC) evaluating the efficacy and safety of botensilimab (BOT) as monotherapy and in combination with balstilimab (BAL) or standard of care in patients with metastatic heavily pre-treated colorectal cancer.\n\n\nThe phase 2 study follows an expanded phase 1 study of over 100 patients with a median of four prior lines of therapy and with 25% having failed previous immunotherapy. At ESMO GI earlier this year, data from the phase 1 study were presented. Among the evaluable patients (n=69) who did not have active liver metastases, a confirmed objective response rate of 23% and a median overall survival of 20.9 months were observed.\n\n\n\"There is a significant need for improved treatment options for heavily pre-treated CRC patients and we anticipate data from ACTIVATE-Colorectal will build upon the positive results from our phase 1 study,\" said Chief Medical Officer, Dr. Steven O’Day. \"Our gratitude goes out to the patients, care partners, physicians, and nurses involved in this trial, as we push forward with BOT/BAL to bridge vital gaps in cancer care.\"\n\n\nAgenus is exploring global accelerated approval strategies for CRC. The totality of data from the phase 1 and 2 studies will contribute to a planned Biologics License Application to the U.S. FDA in 2024. The U.S. FDA has granted Fast Track designation for BOT/BAL in patients with non-MSI-H/dMMR metastatic colorectal cancer and no active liver involvement who 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.\n\n\nAbout Botensilimab\n\n\nBotensilimab is an investigational multifunctional anti-CTLA-4 immune activator designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to \"cold\" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and other investigational therapies. Botensilimab augments immune responses acro...