Key insights
- Merck shares fell 3.7% after a Phase 3 kidney cancer drug trial failed to meet its primary endpoints. The trial tested experimental combinations against Keytruda plus Lenvima, but neither showed superior progression-free or overall survival. An analyst estimates a minor impact on Merck's sales. The FDA is reviewing other applications based on a different trial.
Investing.com -- Merck & Co. (NYSE:MRK) shares fell 3.7% Tuesday after the company and partner Eisai announced their Phase 3 LITESPARK-012 trial for advanced renal cell carcinoma failed to meet its primary endpoints.
The trial, which enrolled 1,688 patients with advanced clear cell renal cell carcinoma, tested two experimental combination regimens against the established treatment of Keytruda plus Lenvima. Neither combination demonstrated superior progression-free survival or overall survival compared to the control arm at a pre-specified interim analysis.
One experimental regimen combined Keytruda, Lenvima, and Welireg, while the other tested MK-1308A plus Lenvima. The companies said safety profiles remained consistent with previously observed data for the individual medicines.
"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," said Dr. M. Catherine Pietanza, Vice President of Global Clinical Development at MSD Research Laboratories.
Bloomberg Intelligence analyst John Morphy commented, "Merck and Eisai’s 1L kidney cancer setback lowers our 2030 Welireg sales estimate by about $300 million, or 13%, but has limited impact on Merck at less than 1% of company sales. The LITESPARK-012 study showed no progression-free or overall survival benefit from adding Welireg to Lenvima and Keytruda, likely ending its 1L RCC chance given no other ongoing studies."
The trial results do not affect other ongoing studies in the LITESPARK clinical program. The FDA has accepted two supplemental New Drug Applications for review based on the Phase 3 LITESPARK-011 trial, with a target action date of October 4, 2026.
Renal cell carcinoma represents the most common type of kidney cancer, with approximately 435,000 new cases diagnosed worldwide in 2022.
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