Merck & Co Inc (NYSE:MRK) announced data from Phase 3 KEYNOTE-716 trial of Keytruda (pembrolizumab) as adjuvant treatment for patients with resected stage IIB and IIC melanoma.
- The trial has met its key secondary endpoint of distant metastasis-free survival (DMFS) at a prespecified interim analysis.
- In the trial, adjuvant treatment with Keytruda demonstrated a statistically significant improvement in the endpoint of DMFS compared to placebo in these patients.
- No new safety signals were observed.
- At the interim analysis, treatment with Keytruda also continued to show an improvement in recurrence-free survival (RFS) compared to placebo.
- As previously reported, KEYNOTE-716 met the primary endpoint of RFS at the first interim analysis, which supported FDA approval for this indication in December 2021.
- In the U.S., Keytruda is approved for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB, IIC or III melanoma following complete resection.
- Additional global regulatory submissions based on KEYNOTE-716 are ongoing.
- Price Action: MRK shares are down 1.14% at $76.94 during the market session on the last check Monday.
