Merck’s KEYTRUDA Prolongs Recurrence-Free Survival for Melanoma in Phase 3

 Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-716 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, met its primary endpoint of recurrence-free survival (RFS) for the adjuvant treatment of patients with surgically resected high-risk stage II melanoma. At an interim analysis, treatment with KEYTRUDA as a single agent showed a statistically significant and clinically meaningful improvement in RFS compared with placebo as adjuvant therapy for these patients. No new safety signals were observed. These results will be presented at an upcoming medical meeting. Based on these data, the U.S. Food and Drug Administration (FDA) has accepted a new supplemental Biologics License Application (sBLA) for KEYTRUDA for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA), or target action, date of December 4, 2021.

“KEYNOTE-716 is the first Phase 3 study to evaluate adjuvant therapy solely for stage IIB and IIC melanoma – an area with high unmet need,” said Dr. Jason Luke, director, Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center. “By moving immunotherapy with KEYTRUDA to earlier stages of melanoma, we have the opportunity to reduce the risk of recurrence for high-risk stage II patients compared to observation alone following complete resection.”

https://www.businesswire.com/news/home/20210805005406/en/Merck%E2%80%99s-KEYTRUDA%C2%AE-pembrolizumab-Significantly-Prolonged-Recurrence-Free-Survival-RFS-Compared-to-Placebo-as-Adjuvant-Therapy-for-Patients-With-Stage-II-Resected-High-Risk-Melanoma-in-Phase-3-KEYNOTE-716-Trial