Initial US Approval
20141
Indications
The treatment of patients with unresectable or metastatic colorectal cancer (mCRC) and high microsatellite instability (MSI-H) or DNA mismatch repair deficiency (dMMR)as determined by an FDA-approved test.1
Recommended Dose/Route (MSI-H or dMMRmCRC)
Pembrolizumab200 mg every 3 weeks or 400 mg every 6 weeks; until disease progression, unacceptable toxicity, or up to 24 months.1
Dose Reductions for Adverse Reactions
No dose reductions are recommended. Withhold or discontinue pembrolizumab to manage adverse reactions.1
Pivotal Studies
KEYNOTE-177 (NCT02563002)2
Key Inclusion Criteria: A total of 307 patients with previously untreated unresectable or metastatic MSI-H or dMMR CRC.1
Treatment
Pembrolizumab 200 mg intravenously every 3 weeks or investigator’s choice of the following chemotherapy regimens given intravenously every 2 weeks.1
Safety
The most common any grade adverse events in patients receiving pembrolizumab included diarrhea, fatigue, nausea, abdominal pain, decreased appetite and vomiting. Immune-mediated adverse events and infusion reactions occurred in 31% of patients.2,3
Permanent Discontinuation Due to AEs: 10%2,3
References
- KEYTRUDA (pembrolizumab) [package insert]. Whitehouse Station, NJ, USA: Merck & Co., Inc.; 12/2018.
- Diaz LA Jr, Shiu KK, Kim TW, et al. Pembrolizumab versus chemotherapy for microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer (KEYNOTE-177): final analysis of a randomised, open-label, phase 3 study. Lancet Oncol. 2022;23(5):659-670. doi: 10.1016/S1470-2045(22)00197-8.
- André T, Shiu KK, Kim TW, et al. Pembrolizumab in microsatellite-instability-high advanced colorectal cancer. N Engl J Med. 2020;383(23):2207-2218. doi: 10.1056/NEJMoa2017699.