- Merck (NYSE:MRK) announces that the Phase 3 KEYNOTE-716 trial investigating Keytruda, 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, Keytruda 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 FDA has accepted a new 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 with PDUFA date of December 4, 2021.