Merck and Eisai Provide Update on Phase 3 LITESPARK-012 Trial Evaluating First-Line Combination Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC)
The LITESPARK-012 trial did not meet its primary endpoints for combination regimens in first-line treatment of advanced renal cell carcinoma.
The phase 3 LITESPARK-012 trial evaluated triplet therapy of KEYTRUDA, LENVIMA and WELIREG (or MK‑1308A plus LENVIMA) versus KEYTRUDA plus LENVIMA as first‑line treatment for patients with advanced clear cell renal cell carcinoma. Interim results show that neither combination met the pre‑specified dual primary endpoints of progression‑free survival or overall survival compared with the current standard of care.
These findings indicate that adding the HIF‑2α inhibitor WELIREG or the anti‑CTLA‑4 antibody quavonlimab to KEYTRUDA+LENVIMA does not improve outcomes for patients with advanced renal cell carcinoma, reinforcing the current standard of care and guiding future research and clinical practice.
Evidence level: Számítógépes vagy elméleti. Modellből vagy adatbányászatból származó jel.
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