After the repeated failure of Keytruda Plus Lenvima, Merck announces…

After the repeated failure of Keytruda Plus Lenvima, Merck announces…

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  • Merck & Co Inc MRK announced data from the last pre-determined overall survival (OS) analysis of the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 study evaluating Keytruda (pembrolizumab) plus Eisai Co Ltd ESALY Lenvima (lenvatinib) for initial treatment of advanced renal cell carcinoma (RCC).
  • These data will be presented at the upcoming annual meeting of the American Society of Clinical Oncology.
  • Also read: Merck and Eisai delay Keytruda-Plus-Lenvima combination study in skin cancer, disappointing in certain types of colorectal cancer.
  • After four years of follow-up, Keytruda plus Lenvima maintained a clinically meaningful OS advantage over sunitinib and reduced the risk of death by 21%.
  • The estimated OS rates at 24 and 36 months were 80.4% and 66.4% for Keytruda plus Lenvima versus 69.6% and 60.2% for Pfizer Inc PFE Sutent (sunitinib) or
  • Keytruda plus Lenvima reduced the risk of disease progression or death by 53%, with a median progression-free survival (PFS) of 23.9 months versus 9.2 months for sunitinib.
  • The objective response rate (ORR) was 71.3%, with a complete response rate (CR) of 18.3% for Keytruda plus Lenvima compared to an ORR of 36.7% with a CR rate of 4.8% for sunitinib .
  • There were no new safety signals and the safety profile at the final OS analysis was consistent with that of the primary analysis.
  • Price promotion: MRK shares closed at $112.30 on Thursday.

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