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Merck's Keytruda Plus Eisai's Lenvima Fail to Improve Survival in Two Phase III Trials

NEW YORK – Merck and Eisai on Friday announced that two clinical trials evaluating the checkpoint inhibitor Keytruda (pembrolizumab) plus the multi-targeted tyrosine kinase inhibitor Lenvima (lenvatinib) have failed to meet key endpoints.

In the Phase III LEAP-003 trial, first-line treatment with Merck's Keytruda and Eisai's Lenvima did not improve metastatic melanoma patients' overall survival versus Keytruda alone. The trial involved biomarker testing so the companies could have insight into the combination's activity according to whether patients had BRAF V600-mutant or BRAF V600-wild type cancers. But after observing limited overall survival improvement with the Keytruda-Lenvima combination, Merck and Eisai have decided to discontinue the trial and told investigators to inform study participants.

In the Phase III LEAP-017 trial, the Keytruda-Lenvima combo also failed to significantly improve overall survival versus standard-of-care treatment with Bayer's Stivarga (regorafenib) or Taiho Oncology's Lonsurf (TAS-102) among previously treated, metastatic colorectal cancer patients whose cancers are mismatch repair proficient and do not have high microsatellite instability. Even though the Keytruda-Lenvima combo showed a trend toward improved overall survival, the degree of the benefit was not statistically significant.

In both studies, Merck and Eisai said there were trends toward improvements in progression-free survival with the combination regimen. Overall survival, however, was a co-primary endpoint in the LEAP-003 trial and the sole primary endpoint in the LEAP-017 trail.

The drugmakers are still performing pre-planned subgroup analysis in these trials. They are also working with investigators to share the results more broadly.