The FDA expanded the approval of the anti–PD-1 immunotherapy pembrolizumab to include first-line treatment of metastatic melanoma.
The FDA in 2014 granted accelerated approval to pembrolizumab (Keytruda, Merck) for treatment of patients with metastatic melanoma who no longer responded to ipilimumab (Yervoy, Bristol-Myers Squibb), an anti–CTLA-4 antibody that has become the standard first-line therapy for metastatic melanoma.
“[The] growing body of evidence in patients with advanced melanoma supports the expanded indication for Keytruda,” Omid Hamid, MD, director of the Melanoma Center at The Angeles Clinic and Research Institute, principal investigator for the pembrolizumab clinical program and a HemOnc Today Editorial Board member, said in a press release. “This approval highlights the importance of Keytruda for advanced melanoma, where we are in need of additional treatment options.”
The FDA based the expanded approval on results of the phase 3 KEYNOTE-006 trial, which included 834 patients with unresectable or metastatic melanoma. Patients had no prior therapy with ipilimumab and had undergone prior therapy with no more than one other systemic treatment.
Researchers assigned 279 patients to pembrolizumab 10 mg/kg every 2 weeks and 277 patients to pembrolizumab 10 mg/kg every 3 weeks until disease progression or unacceptable toxicity. The other 278 patients received ipilimumab 3 mg/kg every 3 weeks for up to four doses.
Results showed improved OS among patients assigned the every-3-week dose of pembrolizumab (HR = 0.63; 95% CI, 0.47-0.83) and the every-2-week dose of pembrolizumab (HR = 0.69; 95% CI, 0.52-0.9). Researchers also reported a higher response rate, longer durations of response, longer PFS and fewer side effects among pembrolizumab-treated patients.
“We are delighted that we found that pembrolizumab is superior to ipilimumab as first-line therapy by improving responses and survival,” researcher Antoni Ribas, MD, professor of medicine, surgery, and molecular and medical pharmacology at University of California, Los Angeles, said in a press release. “With [this] approval by the FDA, physicians will be able to identify patients who are candidates for receiving pembrolizumab as first-line therapy.”