Merck, known as MSD outside of the United States and Canada, has announced positive results from the Phase 3 LITESPARK-005 trial involving their novel drug, WELIREG. This drug is an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, and it was tested in adult patients with advanced renal cell carcinoma (RCC) that had progressed following previous treatments with PD-1/L1 and vascular endothelial growth factor receptor (VEGFR) targeted therapies.
The results revealed a significant reduction in the risk of disease progression or death by 25% when compared to everolimus. In addition to improving progression-free survival (PFS), WELIREG demonstrated a statistically significant improvement in the objective response rate (ORR) compared to everolimus. This marks a notable advancement as it’s the first Phase 3 trial to show positive results in patients with advanced RCC following both immune checkpoint and anti-angiogenic therapies in later lines of treatment.
The interim analysis at a median follow-up of 18.4 months revealed that WELIREG significantly reduced the risk of disease progression or death. This risk reduction remained consistent in the subsequent analysis at a median follow-up of 25.7 months. Notably, treatment with WELIREG also improved ORR at the first interim analysis, indicating a more effective response to the treatment.
The overall survival (OS), the trial’s dual primary endpoint, showed a positive trend favoring WELIREG compared to everolimus. While this result didn’t reach statistical significance, it suggests that WELIREG has the potential to improve outcomes for patients with advanced RCC who urgently need additional treatment options.
Professor Laurence Albiges, the study investigator for LITESPARK-005, emphasized the importance of these findings, particularly for patients with limited treatment options following disease progression. Dr. Marjorie Green, head of late-stage oncology at Merck Research Laboratories, highlighted the significance of this research in addressing the unmet medical needs of these patients and the commitment to advancing research for difficult-to-treat cancers.
WELIREG is a HIF-2α inhibitor therapy that is already approved in the U.S. for the treatment of adult patients with VHL disease. Additional applications for its use are currently under regulatory review worldwide. Based on these positive results, the U.S. FDA has granted priority review for an application to use WELIREG in the treatment of advanced RCC following immune checkpoint and anti-angiogenic therapies, with a target action date set for January 17, 2024.
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