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FDA approves Keytruda for Merkel cell carcinoma
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The FDA today granted accelerated approval to pembrolizumab for adults and children with recurrent locally advanced or metastatic Merkel cell carcinoma.
The decision was based, in part, on data from the multicenter, nonrandomized, open-label Cancer Immunotherapy Trials Network (CITN)-09/KEYNOTE-017 trial, which included 50 patients with recurrent locally advanced or metastatic Merkel cell carcinoma who had not previously received systemic therapy for advanced disease. Patients received 2 mg/kg pembrolizumab (Keytruda, Merck) every 3 weeks.
As HemOnc Today previously reported, the overall response rate was 56% (95% CI, 41-70), which included a 24% complete response rate.
Median duration of response had not been reached. Among 28 responding patients, 96% responded for longer than 6 months and 54% responded for longer than 12 months.
“The CITN-09/KEYNOTE-017 trial demonstrates that first-line treatment with anti-PD-1 therapy provides a meaningful advance for Merkel cell carcinoma patients who have historically had a poor long-term prognosis,” Paul T. Nghiem, MD, PhD, lead investigator, professor of dermatology at University of Washington School of Medicine in Seattle and affiliate investigator at Fred Hutchinson Cancer Research Center, said in a press release. “A few years ago, patients with Merkel cell carcinoma did not have treatment options beyond chemotherapy. As a practicing physician I am pleased that this approval provides another option for patients facing this rare and challenging disease.”
Adverse events that occurred in at least 20% of patients included fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain and abdominal pain.
“Merkel cell carcinoma is an aggressive and fast-growing form of skin cancer that has historically been challenging to treat,” Scot Ebbinghaus, MD, vice president of clinical research at Merck Research Laboratories, said in the release. “We thank the Cancer Immunotherapy Trials Network for initiating and conducting the trial, the National Cancer Institute for their sponsorship of the research that led to this approval and the investigators who contributed to the findings. We also thank the patients who participated in the trial and are pleased to provide an important new therapeutic option for Merkel cell carcinoma patients.”
This application received priority review and breakthrough therapy designation.