Merck and Eisai’s combination for RCC did not meet primary Phase 3 endpoints

Merck (MRK) and Eisai (ESAIY) announced results from the Phase 3 LITESPARK-012 trial evaluating combination regimens for the first-line treatment of patients with advanced clear cell renal cell carcinoma, or RCC. The trial evaluated the triplet therapy of Keytruda – pembrolizumab -, Merck’s anti-PD-1 therapy, plus Lenvima – lenvatinib -, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus Welireg – belzutifan -, Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha inhibitor. The study also evaluated MK-1308A, the coformulation of Keytruda and quavonlimab, Merck’s investigational anti-CTLA-4 antibody, plus Lenvima. Both combination regimens were compared to Keytruda plus Lenvima for these patients. The combination regimens did not meet the dual primary endpoints of progression-free survival and overall survival for the first-line treatment of patients with RCC compared to Keytruda plus Lenvima. The safety profiles of the combination regimens were consistent with those observed in previously reported studies. A full evaluation of the data from this study is ongoing. Results from the LITESPARK-012 trial do not affect other ongoing trials from the LITESPARK clinical program, including those conducted jointly with Eisai.