Keytruda wins FDA priority review based on melanoma trial

US pharma giant Merck & Co (NYSE: MRK) has announced that the Phase III KEYNOTE-716 trial investigating Keytruda (pembrolizumab), its anti-PD-1 therapy, met the 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.

"At Merck, we are innovating to fight cancer earlier"Based on these data, the US Food and Drug Administration (FDA) has accepted a new supplemental Biologics License Application (sBLA) for Keytruda for the adjuvant treatment of adult and pediatric patients with stage IIB or IIC melanoma following complete resection.