Merck and Eisai: LITESPARK‑012 triplet regimens fail to improve PFS and OS versus KEYTRUDA+LENVIMA in first‑line RCC
- Merck and Eisai ran Phase 3 LITESPARK-012 in first-line advanced clear-cell RCC comparing KEYTRUDA (pembrolizumab)+LENVIMA (lenvatinib)+WELIREG (belzutifan) and MK-1308A (KEYTRUDA+quavonlimab)+LENVIMA against KEYTRUDA+LENVIMA
- At a pre-specified interim analysis both combination regimens failed to meet dual primary endpoints of progression-free survival and overall survival versus KEYTRUDA+LENVIMA
- Safety profiles were consistent with prior studies and a full evaluation of the data is ongoing
Trial overview
Merck and Eisai reported results from Phase 3 LITESPARK-012, a first-line study in advanced clear-cell renal cell carcinoma comparing two triplet regimens—pembrolizumab (anti‑PD‑1)+lenvatinib (oral multi‑kinase inhibitor)+belzutifan (oral HIF‑2α inhibitor) and MK‑1308A (coformulation of pembrolizumab and quavonlimab, an anti‑CTLA‑4 antibody) plus lenvatinib—against pembrolizumab plus lenvatinib.
Interim efficacy results
At a pre-specified interim analysis neither triplet regimen met the dual primary endpoints of progression‑free survival (PFS) and overall survival (OS) versus pembrolizumab plus lenvatinib.
Safety and next steps
Observed safety profiles were consistent with prior studies of the individual agents and the pembrolizumab‑lenvatinib combination; a full evaluation of the study data is ongoing and will be shared with investigators and the scientific community.
Source: Merck