Merck, Eisai Shelve Keytruda Plus Lenvima Combo Trial In Skin Cancer Setting, Disappoints In Certain Type Of Colorectal Cancer

  • Merck & Co Inc MRK and Eisai Co Ltd ESALY are discontinuing the Phase 3 LEAP-003 trial evaluating Keytruda plus Lenvima for the first-line treatment of adults with unresectable or metastatic melanoma.
  • The decision is based on the recommendation of an independent Data Monitoring Committee, which determined that Keytruda plus Lenvima did not demonstrate an improvement in overall survival (OS) versus Keytruda alone. 
  • At an earlier interim analysis, the trial's other dual primary endpoint, progression-free survival (PFS), showed a statistically significant improvement in the Keytruda plus Lenvima arm versus the Keytruda plus placebo arm.
  • The companies also announced that the Phase 3 LEAP-017 trial evaluating Keytruda plus Lenvima did not meet its primary endpoint of OS for unresectable and metastatic colorectal cancer that is mismatch repair proficient or not microsatellite instability-high who experienced disease progression on or became intolerant to, prior therapy. 
  • In the final pre-specified analysis of OS, a trend toward improvement was observed with Keytruda plus Lenvima versus regorafenib or TAS-102 (trifluridine and tipiracil hydrochloride); however, these results did not meet statistical significance. 
  • A trend toward improvement was also observed in PFS, objective response rate, and duration of response with Keytruda plus Lenvima versus regorafenib or TAS-102.
  • Previously, Keytruda plus Lenvima's other trial failed to meet their primary endpoints in unresectable hepatocellular carcinoma
  • Price Action: MRK shares are down 0.37% at $111.91 during the premarket session on the last check Monday.
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