Merck and Eisai Highlighted Update on P-III Trials (LEAP-003) and (LEAP-017) of Keytruda (pembrolizumab) + Lenvima (lenvatinib)

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Merck and Eisai Highlighted Update on P-III Trials (LEAP-003) and (LEAP-017) of Keytruda (pembrolizumab) + Lenvima (lenvatinib)


  • The 2 P-III trials (LEAP-003) evaluating Keytruda + Lenvima vs Keytruda alone & (LEAP-017) evaluating Keytruda + Lenvima vs regorafenib or TAS-102 in 660 & 434 patients with unresectable or metastatic melanoma & colorectal cancer i.e., pMMR or not MSI-H
  • Based on IDMC recommendation, the companies decided to discontinue the (LEAP-003) trial by reviewing the data from a planned interim analysis & determined that the combination therapies failed to show improvement in OS
  • The (LEAP-017) trial did not meet its 1EPs of OS, improvement also observed in 2EPs of PFS, ORR & DoR. The safety profile was consistent with prior reported data in both trials. Keytruda + Lenvima was approved in the US, the EU, Japan & other countries for advanced RCC & certain types of advanced EC

Ref: Merck | Image: Merck

Related News:- Merck and Eisai Provide P-III (LEAP-002) Trial Update of Keytruda (pembrolizumab) + Lenvima (lenvatinib) for Unresectable Hepatocellular Carcinoma

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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