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FDA Approves Pembrolizumab for Merkel Cell Carcinoma

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Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.

The FDA’s approval was based on Cancer Immunotherapy Trials Network protocol 9 (CITN-09), also known as KEYNOTE-017, a multicenter, nonrandomized, open-label trial that enrolled 50 patients with recurrent locally advanced or metastatic Merkel cell carcinoma who had not received prior systemic therapy for advanced disease. Patients received pembrolizumab at 2 mg/kg every 3 weeks.

KEYNOTE-017 Findings

The major efficacy outcome measures were overall response rate and response duration assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumors, version 1.1. The overall response rate was 56% (95% confidence interval [CI] = 41%–70%) with a complete response rate of 24%. The median response duration was not reached. Among the 28 patients with responses, 96% had response durations of greater than 6 months and 54% had response durations of greater than 12 months.

The most common adverse reactions of pembrolizumab reported in at least 20% of patients who received pembrolizumab as a single agent were fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain, and abdominal pain.

The recommended pembrolizumab dose for Merkel cell carcinoma is 200 mg administered as a 30-minute intravenous infusion every 3 weeks for adults; 2 mg/kg (to a maximum of 200 mg) administered as a 30-minute intravenous infusion every 3 weeks for pediatric patients less than 18 years of age.

The FDA granted this application priority review and Breakthrough Therapy designation.

View the full prescribing information for pembrolizumab.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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