In a phase III, open-label trial, 307 treatment-naive patients with metastatic microsatellite-instability-high (MSI-H)–mismatch-repair-deficient colorectal cancer were randomly assigned to either pembrolizumab or 5-fluorouracil-based therapy with or without bevacizumab or cetuximab as first-line treatment. At a median follow-up 32.4 months, patients in the pembrolizumab group had higher progression-free survival than patients in the chemotherapy group (median 16.5 versus 8.2 months; HR 0.60; 95% CI 0.45–0.80; P = 0.0002). 43.8% of the pembrolizumab group and 33.1% of the chemotherapy group had an overall response. Serious treatment-related adverse effects were lower in the pembrolizumab group.
André, T. et al. Pembrolizumab in microsatellite-instability–high advanced colorectal cancer. N. Engl. J. Med. 383, 2207–2218 (2020)
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Hindson, J. PD1 blockade for advanced MSI-H CRC. Nat Rev Gastroenterol Hepatol 18, 82 (2021). https://doi.org/10.1038/s41575-021-00415-7