Merck's Two Keytruda Combo Cancer Trials Miss Primary Goal

  • Merck & Co Inc's MRK Phase 3 KEYNOTE-921 trial of Keytruda combined with chemotherapy (docetaxel) did not meet its dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) for metastatic castration-resistant prostate cancer (mCRPC). 
  • The study showed modest trends toward improving both OS and rPFS for patients who received Keytruda + chemo combo than chemotherapy alone; however, these results did not meet statistical significance.
  • Separately, Merck and Eisai Co Ltd's ESALY Phase 3 LEAP-002 trial of Keytruda plus Lenvima did not meet its dual primary endpoints of OS and progression-free survival (PFS) in unresectable hepatocellular carcinoma (uHCC). 
  • The median OS of the Lenvima monotherapy arm was longer than that observed in previously reported clinical trials evaluating Lenvima monotherapy in uHCC. 
  • The safety profile of Keytruda was consistent with that observed in previously reported studies. 
  • Price Action: MRK shares are up 0.43% at $87.99 during the premarket session on the last check Wednesday.
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