Pembrolizumab Gains FDA Approval for Merkel Cell Carcinoma

The FDA has granted an accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

The approval was based on the phase II CITN-09/KEYNOTE-017 trial (NCT02267603), in which pembrolizumab elicited an overall response rate (ORR) of 56% (95% CI, 41%-70%) and a complete response rate of 24% in patients who did not previously receive systemic therapy for their advanced disease.

In the multicenter, nonrandomized, open-label, trial, 50 treatment-naïve patients with recurrent locally advanced or metastatic MCC received pembrolizumab at 2 mg/kg every 3 weeks. The primary endpoints were ORR and response duration, as assessed by blinded independent central review per RECIST v1.1 criteria.

Results of the trial showed that the median response duration was not reached (range, 5.9-34.5+). 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.

Read more about this approval on OncLive.