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     157  0 Kommentare Nature Medicine Reports Agenus’ Novel Immunotherapy Demonstrates Clinical Activity Against a Deadly Form of Colorectal Cancer on the Rise in Americans Under 50

    Agenus has published results from a groundbreaking clinical trial in Nature Medicine, revealing the potential of a novel immunotherapy combination for treating microsatellite stable metastatic colorectal cancer (MSS mCRC), a cancer type historically resistant to immunotherapy. This pioneering research, led by an international team of oncologists, focuses on the efficacy and safety of botensilimab (BOT), an Fc-enhanced anti-CTLA-4 antibody, in combination with balstilimab (BAL), an anti-PD-1 antibody. Together, these therapies are designed to activate the immune system against a cancer type historically resistant to immunotherapy.

    Colorectal cancer is the second leading cause of cancer death in the United States. While overall death from CRC has declined, survival rates for advanced disease remain poor, with an increasing burden on younger populations. For the 95% of patients diagnosed with MSS mCRC, there are no approved immunotherapies, making long-term survival exceedingly rare.

    Publication Highlights:

    • Patient Group: The Phase 1 trial assessed 148 heavily pretreated MSS mCRC patients treated with the combination at active doses; 101 of these with long term follow-up, and 77 of these without active liver metastases as of the data cutoff of November 29, 2023.
    • Safety and Tolerability: There were no treatment related deaths in patients treated with the combination BOT/BAL, and side effects were manageable and consistent with immunotherapies.
    • Efficacy Results: In the 77 patients without active liver metastases with a median follow-up of 13 months, the Objective Response Rate (ORR) was 22% (17/77) and a majority of these responses were ongoing.
    • Long-term Benefits: Noteworthy are the durable responses observed in those without active liver metastases, with a median Duration of Response (DOR) not yet reached and the majority of patients (69%) alive at one year.

    In a recent press release, Agenus disclosed updated results as of the data cutoff of March 1, 2024. At that time, the ORR had increased to 23% in the 77 patients, with a median follow up of 13.6 months. The median duration of response in the 18 responders was still not reached. The estimated 12-month and 18-month OS rates were 71% and 62%, respectively. The median OS was 21.2 months. The most common safety observations were immune-related diarrhea or colitis, which were managed in accordance with standard therapies.

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    Nature Medicine Reports Agenus’ Novel Immunotherapy Demonstrates Clinical Activity Against a Deadly Form of Colorectal Cancer on the Rise in Americans Under 50 Agenus has published results from a groundbreaking clinical trial in Nature Medicine, revealing the potential of a novel immunotherapy combination for treating microsatellite stable metastatic colorectal cancer (MSS mCRC), a cancer type historically …