Merck & Co (MSD) and Eisai’s combination therapies failed to meet the dual primary endpoints of progression-free survival (PFS) and overall survival (OS) for renal cell carcinoma (RCC) in the Phase III LITESPARK-012 trial.
The randomised, open-label trial included 1,688 participants.
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Researchers evaluated combinations of MSD’s Keytruda (pembrolizumab) and Welireg (belzutifan), along with Eisai’s Lenvima (lenvatinib), as first-line treatments for advanced clear cell RCC.
A second combination tested Lenvima with MK-1308A, a co-formulation featuring Keytruda and MSD’s experimental antibody quavonlimab.
Both treatment arms were compared with the established Keytruda plus Lenvima regimen.
According to an interim analysis, these new combination regimens did not meet the dual primary endpoints in patients with advanced RCC when compared to the Keytruda and Lenvima combination.
The companies reported that the safety profiles of these regimens were consistent with safety findings from earlier studies of the same drugs and combinations. Detailed data evaluation from the study remains ongoing.
Merck and Eisai plan to share findings from this trial with the scientific community.
MSD Research Laboratories global clinical development vice-president Dr Catherine Pietanza said: “With the LITESPARK-012 trial, we explored whether combining therapies with established activity could improve upon well-established standards set by Keytruda-based regimens, reflecting our commitment to continuously explore ways to improve outcomes for the kidney cancer community.
“While these regimens did not demonstrate the results we hoped, the data deepen our understanding of advanced renal cell carcinoma and will help shape the next generation of treatment approaches.”
Ongoing trials from the LITESPARK programme are not affected by these results.
The US Food and Drug Administration (FDA) has also accepted two supplemental new drug applications (NDA) for Welireg and Lenvima based on separate Phase III data, with a target action date of 4 October 2026.
