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Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai announced results from the Phase 3 LITESPARK-012 trial evaluating combination regimens for the first-line treatment of patients with advanced clear cell renal cell carcinoma (RCC). The study assessed two experimental triplet or coformulation-based regimens against KEYTRUDA (pembrolizumab) plus LENVIMA (lenvatinib).
LITESPARK-012 is a randomized, open-label Phase 3 trial. It evaluated:
The primary endpoints were progression-free survival (PFS) and overall survival (OS). Secondary endpoints included objective response rate and duration of response, as well as safety. The trial enrolled 1,688 patients randomized to three arms.
At a pre-specified interim analysis, the combination regimens did not meet the dual primary endpoints of PFS and OS for first-line treatment of patients with RCC compared with KEYTRUDA plus LENVIMA.
The companies said the safety profiles of the combination regimens were consistent with those observed in previously reported studies of the individual medicines and the KEYTRUDA plus LENVIMA combination. A full evaluation of the data is ongoing, and Merck and Eisai plan to work with investigators to share results with the scientific community.
Dr. M. Catherine Pietanza, Vice President, Global Clinical Development, Merck Research Laboratories, said the trial explored whether combining therapies with established activity could improve outcomes versus KEYTRUDA-based regimens, and that while the regimens did not demonstrate the hoped-for results, the data deepen understanding of advanced RCC and may help shape future treatment approaches.
Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai Inc., said the findings reinforce the central role of KEYTRUDA plus LENVIMA in first-line advanced RCC treatment, and that trial results help inform how health care providers view the evolving treatment paradigm.
The companies said results from LITESPARK-012 do not affect other ongoing trials in the LITESPARK clinical program, including those conducted jointly with Eisai. Separately, the U.S. Food and Drug Administration (FDA) has accepted two supplemental New Drug Applications (sNDA) for review based on the Phase 3 LITESPARK-011 trial evaluating WELIREG in combination with LENVIMA for certain previously treated patients with advanced RCC. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of Oct. 4, 2026.
KEYTRUDA is approved as adjuvant monotherapy and in combination regimens for appropriate patients with RCC in the U.S., European Union (EU), Japan and other countries. KEYTRUDA plus LENVIMA is approved in the U.S., EU, Japan and other countries for first-line treatment of adult patients with advanced RCC. LENVIMA is also approved as KISPLYX for advanced RCC in the EU.
LENVIMA in combination with everolimus is approved in the U.S., EU and other regions for adult patients with advanced RCC following one prior anti-angiogenic therapy. WELIREG is approved in the U.S., EU, Japan and other countries for adult patients with advanced clear cell RCC following a PD-1/PD-L1 inhibitor and 1-2 VEGF-TKIs, based on results from the Phase 3 LITESPARK-005 trial.
Renal cell carcinoma is described as the most common type of kidney cancer, with about nine out of 10 kidney cancer diagnoses being RCC. The companies cited that in 2022 there were about 435,000 new cases of kidney cancer diagnosed and approximately 156,000 deaths worldwide.
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