Agenus announced updated results from its Phase 1 clinical trial of BOT/BAL combination therapy in patients with metastatic CRC that is not microsatellite instability-high, or MSS, or deficient mismatch repair, or dMMR. These findings build upon the compelling clinical activity demonstrated by BOT/BAL across nine different cancer types in Agenus’ broad clinical development program. In the Phase 1 trial of 77 patients with refractory MSS-CRC without active liver metastases, a 23% overall response rate, or ORR, was observed after a median follow up of 13.6 months at the data cutoff of March 1, 2024. The median duration of response in 18 responders was not yet reached. The estimated 12-month and 18-month OS rates were 71% and 62%, respectively. The median OS was 21.2 months. The Phase 2 trial has completed enrollment and the company plans to discuss the encouraging interim results with the FDA. Pending planned meetings with the FDA, Agenus plans to submit a Biologics License Application for BOT/BAL in refractory MSS CRC later this year and plans to present detailed Phase 2 efficacy results, including response durability and updated Phase 1 survival data, at a major medical conference in the second half of 2024. This growing body of clinical evidence underscores the significant potential of BOT/BAL to transform the treatment landscape for difficult-to-treat solid tumors.
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