LITESPARK-012 RCC Trial: Triplet Regimens Fail to Beat Standard Front-Line Therapy

Merck and Eisai reported interim results from Phase 3 LITESPARK-012 in first-line advanced clear cell RCC, showing that the triplet regimens (KEYTRUDA+LENVIMA+WELIREG and MK-1308A+LENVIMA) did not meet the dual primary endpoints of progression-free survival and overall survival versus KEYTRUDA+LENVIMA. Safety aligned with prior data, and full data analysis is ongoing with plans to share results with investigators and the scientific community. The findings do not affect other LITESPARK trials, and KEYTRUDA+LENVIMA remains an approved first-line RCC option; FDA has also accepted sNDA for LITESPARK-011 with a target action date of Oct 4, 2026.