FDA approves adjuvant Keytruda for certain adults, children with stage IIB, IIC melanoma
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The FDA approved pembrolizumab as adjuvant therapy for adults and children aged 12 years 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 aged 12 years or older with stage III melanoma following complete resection.
“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 nearly the same as for patients with later-stage disease, for whom treatment is recommended,” Jason J. Luke, MD, FACP, director of the Cancer Immunotherapeutics Center and associate professor of medicine at UPMC Hillman Cancer Center and University of Pittsburgh School of Medicine, said in a Merck press release. “[The] approval of pembrolizumab for the adjuvant treatment of patients 12 years and older with stage IIB and IIC melanoma following complete resection is an important advance that provides these patients with a new option that can help reduce the risk [for] their cancer returning.”
The FDA based the approval on results of the first interim analysis of the randomized, phase 3 KEYNOTE-716 trial.
As Healio previously reported, the study included 976 patients aged 12 years 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 pembrolizumab (2 mg/kg for children) and 489 patients to placebo every 3 weeks for 17 cycles up to 1 year. Treatment continued until disease recurrence or unacceptable toxicity. Investigators stratified randomization according to T category, with a separate stratum for children.
Results showed pembrolizumab significantly extended recurrence-free survival compared with placebo (HR = 0.65; 95% CI, 0.46-0.92). Neither group reached median RFS.
After median follow-up of 14.4 months, 11% of patients in the pembrolizumab group experienced recurrence or died vs. 17% of patients in the placebo group.
Efficacy data extrapolated from studies among adults supported efficacy of pembrolizumab among children aged 12 years or older with stage IIB, IIC and III melanoma, given similar biology and pharmacology of drug effect, as well as similar exposure-response for efficacy and safety, according to the press release.
The pembrolizumab group had higher rates of grade 3 or higher adverse events of any cause (25.9% vs. 17.1%) and drug-related adverse events that led to discontinuation (15.3% vs. 2.5%), according to previously reported results of the trial. However, no deaths due to any of these events occurred in the pembrolizumab group, whereas four deaths due to any-cause adverse events occurred in the placebo group.
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