Merck, Eisai provide update on Phase 3 LEAP-010 trial

Merck (MRK) and Eisai (ESAIY) provided an update on the Phase 3 LEAP-010 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma whose tumors express PD-L1. The primary endpoints of the study were overall survival, progression-free survival, and objective response rate. Two planned interim analyses were conducted by an independent Data Monitoring Committee over an 11-month period. In the first analysis, KEYTRUDA plus LENVIMA showed a statistically significant improvement in PFS and ORR versus KEYTRUDA plus placebo. At the second analysis, KEYTRUDA plus LENVIMA did not demonstrate an improvement in OS compared to KEYTRUDA plus placebo, and the likelihood of reaching the protocol-specified threshold for statistical significance for OS was evaluated by Merck and Eisai and deemed to be low. Accordingly, the study will be closed, and the companies are informing investigators of this decision. The safety profile of KEYTRUDA plus LENVIMA was consistent with previously reported data on the combination. A full evaluation of the data from this study, including pre-planned subgroup analyses, is ongoing. The companies will work with investigators to share the results with the scientific community.