Merck and Eisai reported that a pre-specified interim analysis of the Phase 3 LITESPARK-012 trial did not meet its dual primary endpoints of progression-free survival and overall survival for first-line treatment of patients with advanced clear cell renal cell carcinoma.
The randomized, open-label study enrolled 1,688 patients and compared two experimental regimens, a triplet of KEYTRUDA (pembrolizumab) plus LENVIMA (lenvatinib) plus WELIREG (belzutifan), and MK-1308A (a coformulation of pembrolizumab and quavonlimab) plus LENVIMA, against the approved KEYTRUDA plus LENVIMA combination.
Safety profiles for the investigational combinations were consistent with previously reported data for the individual medicines and the KEYTRUDA plus LENVIMA regimen.
A full evaluation of the data is ongoing, and Merck and Eisai said they will work with investigators to share results with the scientific community.
The companies noted that LITESPARK-012 results do not affect other LITESPARK trials and reiterated that the FDA has accepted supplemental applications from Merck for WELIREG plus LENVIMA with a PDUFA date of 4 October 2026.
