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
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