Merck Says WELIREG,LENVIMA Combination Therapy Meets PFS Goal In Phase 3 Kidney Cancer Trial

(RTTNews) - Merck & Co Inc. (MRK) and Eisai oCo. Ltd (ESALY.PK) on Tuesday said that the Phase 3 LITESPARK-011 trial evaluating Merck's WELIREG in combination with Eisai's LENVIMA met one of its primary endpoints of progression-free survival (PFS) in patients with advanced renal cell carcinoma (RCC) whose disease had progressed on or after treatment with anti-PD-1/L1 therapy.

The combination demonstrated a statistically significant and clinically meaningful improvement in PFS compared with cabozantinib at an interim analysis. Overall survival (OS), the study's other primary endpoint, will be evaluated at a future analysis.

Merck and Eisai said the safety profiles of WELIREG and LENVIMA were consistent with previous studies of the individual therapies, and no new safety signals were observed.