06 Dec 2021
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The FDA has approved pembrolizumab as adjunctive therapy for adults and children 12 years of age or older with stage IIB or IIC melanoma after complete resection.
The agency also expanded the indication for adjuvant pembrolizumab (Keytruda, Merck), an anti-PD-1 therapy, to include children 12 years of age or older with stage III melanoma after complete resection.
Jason J. Luke
“The standard of care for patients with resected stage IIB and IIC melanoma has been observation, despite the fact that for these patients the risk [for] recurrence is almost the same as in patients with later stage of the disease, for whom treatment is recommended.” Jason j. Luke, M.D., FACP, director of the Cancer Immunotherapeutics Center and associate professor of medicine at the UPMC Hillman Cancer Center and the University of Pittsburgh School of Medicine, in a press release from Merck. “[The] Approval of pembrolizumab for the adjuvant treatment of patients 12 years of age and older with stage IIB and IIC melanoma after complete resection is an important advance that offers these patients a new option that may help reduce risk [for] their cancer comes back.”
The FDA based the approval on the results of the first interim analysis of the randomized phase 3 KEYNOTE-716 study.
As Healio previously reported, the study included 976 patients 12 years of age or older who underwent complete resection of cutaneous stage IIB or stage IIC melanoma and had no lymph node involvement.
Researchers randomly assigned 487 patients to 200 mg of pembrolizumab (2 mg/kg for children) and 489 patients to placebo every 3 weeks for 17 cycles to 1 year. Treatment was continued until disease recurrence or unacceptable toxicity. Researchers stratified randomization by T category, with a separate layer for children.
The results showed that pembrolizumab significantly prolonged recurrence-free survival compared to placebo (HR = 0.65; 95% CI 0.46-0.92). Neither group reached the median RFS.
After median follow-up of 14.4 months, 11% of patients in the pembrolizumab group experienced relapse or died versus 17% of patients in the placebo group.
Efficacy data extrapolated from studies in adults supported the efficacy of pembrolizumab in children 12 years of age or older with stage IIB, IIC, and III melanoma, given similar biology and pharmacology of drug effect, as well as comparable exposure-response for efficacy and safety, according to the press release.
The pembrolizumab group had higher rates of Grade 3 or greater adverse reactions from any cause (25.9% vs. 17.1%) and drug-related adverse events leading to discontinuation (15.3% vs. 2.5%), according to previously reported results of the trial. However, there were no deaths from any of these events in the pembrolizumab group, while four deaths from adverse events from any cause occurred in the placebo group.
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