The Food and Drug Administration (FDA) has approved Keytruda® (pembrolizumab) for the adjuvant treatment of adult and pediatric patients 12 years and older with stage IIB or IIC melanoma following complete resection. The indication for Keytruda as adjuvant treatment for stage III melanoma following complete resection has also been expanded to include pediatric patients (12 years of age and older).
The approval was based on data from the phase 3 KEYNOTE-716 trial (ClinicalTrials.gov Identifier: NCT03553836), which enrolled 976 patients with completely resected stage IIB or IIC melanoma, who had not been treated beyond complete resection.
Participants were randomly assigned to receive pembrolizumab 200mg or the pediatric (12 years of age and older) dose of pembrolizumab 2mg/kg intravenously (up to a maximum of 200mg) every 3 weeks or placebo for up to 1 year until disease recurrence or unacceptable toxicity.
The primary endpoint of the study was recurrence free survival, defined as the time between the date of randomization and the date of first recurrence or death.
Findings showed a statistically significant improvement in recurrence free survival for patients in the pembrolizumab arm compared with the placebo arm (hazard ratio, 0.65, 95% CI, 0.46-0.92; P=.0132). At a median follow-up of 14.4 months, 11% (n=54/487) of patients in the pembrolizumab arm had recurrence or died compared with 17% (n=82/489) of patients in the placebo arm.
Pembrolizumab is a PD-1 blocking antibody and has the potential to induce immune-mediated adverse reactions. Adverse reactions reported in KEYNOTE-716 were similar to those observed in the KEYNOTE-54 trial, which included patients with stage III melanoma, and in patients with melanoma or non-small cell lung cancer treated with pembrolizumab as a single agent.
“Keytruda was the first anti-PD-1 therapy to be approved in metastatic melanoma in the US 7 years ago,” said Dr Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “With today’s approval, we can now offer healthcare providers and patients 12 years and older the opportunity to help prevent melanoma recurrence with Keytruda across resected stage IIB, stage IIC and stage III melanoma.”
FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adult and Pediatric (≥12 Years of Age) Patients With Stage IIB or IIC Melanoma Following Complete Resection. News release. Merck. Accessed December 6, 2021. https://www.businesswire.com/news/home/20211203005607/en/FDA-Approves-Merck%E2%80%99s-KEYTRUDA%C2%AE-pembrolizumab-as-Adjuvant-Treatment-for-Adult-and-Pediatric-%E2%89%A512-Years-of-Age-Patients-With-Stage-IIB-or-IIC-Melanoma-Following-Complete-Resection.