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KEYNOTE-716 Trial, Led by UPMC's Jason Luke, MD, Leads to FDA Approval for Pembrolizumab as Adjuvant Melanoma Treatment

The FDA approved pembrolizumab (Keytruda, Merck) for the adjuvant treatment of adult and pediatric patients with stage IIB or IIC melanoma following complete resection. The approval is based on the initial results from the placebo-controlled, randomized KEYNOTE-716 trial that showed significant efficacy versus placebo in preventing both locoregional and distant recurrence of the disease.

Jason Luke, MD, FACPThe principal investigator of the KEYNOTE-716 trial is Jason Luke, MD, FACP, associate professor of medicine in the Division of Hematology/Oncology and the director of the Cancer Immunotherapeutics Center within the UPMC Hillman Cancer Center Immunology and Immunotherapy Program.

“Our primary endpoint for the study was recurrence-free survival, and we also investigated distant metastasis-free survival and overall survival rates, along with general safety, quality-of-life measures, and adverse events,” says Dr. Luke.

Close to 1,000 individuals were enrolled in the global trial from 150 centers. Participants were eligible if they were > 12 years of age and had newly diagnosed, resected, high-risk melanoma. Participants were randomized to either placebo or pembrolizumab for up to 17 cycles receiving 200mg infusions every three weeks. Pediatric patients received a lower dose of 2 mg/kg.

The pembrolizumab cohort experienced an overall recurrence rate of 11.1% while the placebo cohort was found to have an overall recurrence rate of 16.8%. This reduction in recurrence rates and death between the pembrolizumab and placebo cohorts likely marks the beginning of a new treatment era for these high-risk tumors.

“From my perspective, the most important takeaways for clinicians from our study right now are the realizations of the true high-risk nature of stage IIB/C melanoma, and that treatment with pembrolizumab significantly reduces the risk of recurrence, be it locoregional or distant,” says Dr. Luke. “Stage II melanoma was really looked at as low-risk only because there was nothing available outside surgery to offer these patients. Our study and its findings should definitively change this perception and future clinical practice."

This marks the first anti-programmed cell death protein-1 (PD-1)/anti-programmed cell death ligand-1 (PD-L1) therapy to demonstrate a recurrence-free survival benefit in the adjuvant setting for this disease.

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