Immuno-oncology leader, Agenus , shared promising data from its Phase 1b trial on the botensilimab and balstilimab combination at a late-breaking session at the 2023 ESMO World Congress on Gastrointestinal Cancer. The new data show substantial survival benefits and long-lasting responses for patients with non-MSI-H (microsatellite stable or non-microsatellite instability-high) metastatic colorectal cancer previously resistant to chemotherapy and/or immunotherapy.
“The data from our expanded cohort demonstrate remarkable median overall survival and sustained responses in heavily pre-treated patients that historically haven’t responded to immunotherapy. These findings provide evidence of the benefit of botensilimab/balstilimab in metastatic colorectal cancer, the second leading cause of cancer death in the U.S.,” said Dr. Steven O’Day, Chief Medical Officer at Agenus. “Our clinical research has shown confirmed responses in 8 other refractory tumor types, indicating the potential to transform clinical practice and patient outcomes for multiple challenging cancers.”
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Dr. Andrea Bullock, Assistant Professor of Medicine, Harvard Medical School, and study investigator, commented, “The new survival data underscore the potential of the botensilimab/balstilimab combination as an important treatment option for patients with non-MSI-H colorectal cancer. The patients in our study face one of the most challenging cancers to treat and represent the largest patient population with colorectal cancer where only a quarter of patients survive beyond one year with standard of care therapy. Botensilimab plus balstilimab continues to show deep and durable responses with 69% of objective responses still ongoing at the data cutoff.”
Agenus is planning to submit its first Biologics License Application to the U.S. Food & Drug Administration (FDA) for patients with non-MSI-H metastatic colorectal cancer. The ongoing global randomized phase 2 trial for patients with non-active liver metastases has been granted Fast Track Designation from the FDA. Additionally, global randomized Phase 2 trials for the botensilimab/balstilimab combination in melanoma and botensilimab/chemotherapy in pancreatic cancer are underway, with plans to initiate Phase 3 studies in colorectal and non-small cell lung cancer (NSCLC).
SOURCE: Businesswire