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Benzinga
Benzinga
Technology
Vandana Singh

Merck's Keytruda Shows Improved Metastasis-Free Survival In Melanoma Patients

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.
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