Merck & Co. Inc. and Eisai announced interim results from the Phase 3 LITESPARK-011 trial evaluating oral belzutifan (WELIREG) plus lenvatinib (LENVIMA) versus cabozantinib in previously treated patients with advanced clear cell renal cell carcinoma whose disease progressed on or after anti-PD-1/PD-L1 therapy. At a pre-specified interim analysis with a median follow-up of 29.0 months, the combination reduced the risk of disease progression or death by 30% (HR 0.70; p=0.00007) and showed a trend toward improved overall survival (HR 0.85; p=0.06075). Merck said the results are being presented as a late-breaking oral abstract at the 2026 ASCO Genitourinary Cancers Symposium, and the FDA has accepted two supplemental New Drug Applications for review with a PDUFA target action date of Oct. 4, 2026.
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