Merck MRK and its Japanese partner Eisai said Friday they are discontinuing the Phase 3 LEAP-003 trial evaluating Keytruda plus Lenvima for the first-line treatment of adults with unresectable or metastatic melanoma after data showed the combination did not produce an improvement in overall survival, or OS, compared with Keytruda alone. OS was one of two primary endpoints; the other, progression-free survival, did show a statistically significant improvement in an earlier interim analysis of data. The partners said the Phase 3 LEAP-017 trial evaluating Keytruda plus Lenvima as a treatment for patients with unresectable and metastatic colorectal cancer also failed to meet the primary endpoint of OS. The companies are still analyzing the data and will work with investigators to share the results with the scientific community. Merck stock has gained 29% in the last 12 months, while the S& P500 SPX has fallen 9%.
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