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Agenus Unveils New and Updated Botensilimab Data in Colorectal, Pancreatic, Lung, Melanoma, and Sarcoma
U.S. BLA Filing in Microsatellite Stable (MSS) Metastatic Colorectal Cancer (CRC) Planned for Midyear 2024 Potential Accelerated Filings for Advanced
About this update from Agenus Inc.
[{"type":"text","content":"\nU.S. BLA Filing in Microsatellite Stable (MSS) Metastatic Colorectal Cancer (CRC) Planned for Midyear 2024\n\n\nPotential Accelerated Filings for Advanced Pancreatic Cancer and Melanoma in 2025\n\n\nOpportunity to Expand into Early-Stage Cancers Supported by Compelling Neoadjuvant CRC Data\n\n\nLive Webcast Today at 1:00 p.m. EDT\n\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAgenus Inc. (Nasdaq: AGEN), a leader in developing novel immunological agents to treat cancers, today announced first-time and updated data from its ongoing botensilimab/balstilimab (BOT/BAL) clinical programs in advanced colorectal cancer (CRC), neoadjuvant CRC, pancreatic cancer, non-small cell lung cancer (NSCLC), melanoma, and sarcoma. Members of the Agenus leadership team along with key opinion leaders will discuss these findings during a live webcast at 1:00 p.m. EDT (19:00 CEST) at a corporate event at the European Society for Medical Oncology 2023 Conference.\n\n\n“These new and updated data underscore BOT’s broad effectiveness across several advanced solid tumors, demonstrating its potential beyond first-generation immunotherapies and current treatments,” said Dr. Steven O’Day, Chief Medical Officer. “BOT’s versatility, alone, in combination with BAL, or in combination with other standard of care therapies, in early and late-stage solid tumors, positions Agenus to transform cancer care, offering immense promise to patients.”\n\n\nKey highlights across solid tumors include:\n\n\nExtended Follow-up and Additional Data in Refractory MSS CRC Demonstrate Improved Responses and Durability\n\n\nIn 70 efficacy evaluable patients with MSS CRC and no active liver metastases:\n\n\n\nConfirmed (RECIST 1.1) overall response rate (ORR) of 24% was observed, compared to 2.8% reported with standard of care (SOC) in 2/3L+ MSS CRC patients with no active liver metastases1.\n\n\n\n12-month overall survival (OS) of 74% and median OS (mOS) not yet reached. Median follow up now 12.3 months.\n\n\n\nSubsequent data from expanded cohorts and early signals from a 230 patient Phase 2 trial is consistent with the earlier cohort of 70 patients. Based on the totality of the evidence from the Phase 1 and Phase 2 trials, Agenus plans to submit its Biologics License Application (BLA) to the U.S. Food & Drug Administration (FDA) for BOT/BAL in patients with 2/3L+ MSS CRC in midyear 20...