Merck's Keytruda Scores First Approval In Adjuvant Kidney Cancer Setting

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  • The FDA has approved Merck & Co Inc's MRK Keytruda, an anti-PD-1 therapy, for the adjuvant treatment of renal cell carcinoma (RCC).
  • The news comes almost half a year after Merck took the stage at ASCO to report Phase 3 data showing Keytruda cut the risk of cancer relapse or death by 32% compared to placebo, hitting the primary endpoint of disease-free survival. 
  • The study, dubbed KEYNOTE-564, enrolled 994 RCC patients at intermediate-high or high risk of recurrence after a kidney removal or after removal of a kidney and metastatic lesions.
  • The trial will continue to assess overall survival (OS) as a secondary outcome measure.
  • Related content: Benzinga's Full FDA Calendar.
  • Price Action: MRK shares are down 0.06% at $82.55 during the market session on the last check Thursday.
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