The Food and Drug Administration (FDA) approved pembrolizumab on June 29, 2020, for the treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) colorectal cancer (CRC) with no prior systemic treatment for advanced disease. The approval was based on data from Study Keynote-177, which randomly allocated patients to receive either pembrolizumab or standard of care (SOC) with chemotherapy. Overall survival (OS) and independently-assessed progression free survival (PFS) were the primary endpoints. At the time of the final PFS analysis and second pre-specified interim OS analysis, the estimated median PFS was 16.5 months (95% CI: 5.4, 32.4) vs. 8.2 months (95% CI: 6.1, 10.2) in the pembrolizumab and SOC arms, respectively (Hazard Ratio [HR]: 0.60 (95% CI: 0.45, 0.80; two-sided p-value= 0.0004)). FDA assessed unblinded OS data during the review of the application and identified no safety concerns that would preclude approval of this supplement. Adverse reactions occurring in >30% of patients receiving pembrolizumab were diarrhea, fatigue/asthenia, and nausea. Adverse reactions occurring in >30% of patients receiving SOC were diarrhea, nausea, fatigue/asthenia, neutropenia, decreased appetite, peripheral neuropathy (high-level term), vomiting, abdominal pain, constipation, and stomatitis. Duration of treatment in the pembrolizumab arm was almost double (median 11.1 months, range 0-30.6 months) than the duration of treatment in patients receiving SOC (median 5.7 months). Approval of pembrolizumab is likely to change the treatment paradigm for 1st line treatment with MSI-H advanced CRC given the study results and different safety profile.
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