NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend pembrolizumab (KEYTRUDA) as a preferred systemic therapy option for disseminated disease in patients with MCC (category 2A). Pembrolizumab can also be considered for patients who have MCC with recurrent locally advanced or recurrent regional disease, if curative surgery and curative radiation therapy are not feasible (category 2A).1
Category 2A = Based upon lower-level evidence, there is uniform National Comprehensive Cancer Network® (NCCN®) consensus that the intervention is appropriate.1
Preferred intervention = Intervention that is based on superior efficacy, safety, and evidence; and, when appropriate, affordability.1
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BICR = blinded independent central review; CI = confidence interval; CR = complete response; DOR = duration of response; ORR = objective response rate; PR = partial response; RECIST v1.1 = Response Evaluation Criteria In Solid Tumors v1.1.
- Median age was 71 years (range: 46–91 years)
- 68% male
- 90% white
- 48% had an ECOG PS of 0
- 52% had an ECOG PS of 1
- 14% had stage IIIB disease and 86% had stage IV
- 84% had prior surgery and 70% had prior radiation therapy
Q3W = every 3 weeks; ECOG PS = Eastern Cooperative Oncology Group performance status.
The recommended dose of KEYTRUDA in adults is 200 mg every 3 weeks or 400 mg every 6 weeks as an intravenous infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months.
The 400-mg Q6W dosing regimen is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
The recommended dose of KEYTRUDA in pediatric patients is 2 mg/kg (up to a maximum of 200 mg), administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months.
No premedication necessary with KEYTRUDA for adult or pediatric patients.
Q6W = every 6 weeks.