Merck, Eisai: Phase 3 LITESPARK-011 trial met primary endpoints

Merck (MRK) and Eisai (ESAIY) announced that the Phase 3 LITESPARK-011 trial evaluating the dual oral regimen of WELIREG, Merck’s first-in-class oral hypoxia-inducible factor-2 alpha inhibitor, plus LENVIMA, an orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, met one of its primary endpoints of progression-free survival for the treatment of patients with advanced renal cell carcinoma whose disease progressed on or after treatment with anti-PD-1/L1 therapy. At a pre-specified interim analysis, WELIREG plus LENVIMA demonstrated a statistically significant and clinically meaningful improvement in PFS compared to cabozantinib in these patients. The combination also showed a statistically significant improvement in the trial’s key secondary endpoint of objective response rate compared to cabozantinib. A trend toward improvement in overall survival, the study’s other primary endpoint, was observed; however, this result did not reach statistical significance at the time of this interim analysis. Overall survival will be tested at a subsequent analysis, per the clinical protocol. The safety profiles of WELIREG and LENVIMA in this trial were consistent with those observed in previously reported studies for the individual therapies; no new safety signals were observed. Merck and Eisai will discuss these data with regulatory authorities worldwide and will present them at an upcoming medical meeting.