Merck has announced positive results from its Phase 3 LITESPARK-005 trial, which investigated the use of its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, WELIREG, for the treatment of advanced renal cell carcinoma (RCC). The trial showed that WELIREG significantly reduced the risk of disease progression or death compared to everolimus, a previously used therapy. The study also demonstrated a statistically significant improvement in objective response rate (ORR) with WELIREG. The data from the trial are being presented at the European Society for Medical Oncology (ESMO) Congress 2023 and will be discussed with regulatory authorities.
In the LITESPARK-005 trial, WELIREG showed promising results as a treatment for advanced RCC. At the first pre-specified interim analysis, WELIREG significantly reduced the risk of disease progression or death compared to everolimus. The trial also showed that WELIREG was associated with an improved objective response rate. While the trial’s dual primary endpoint of overall survival did not reach statistical significance, the results are encouraging for patients who urgently need additional treatment options.
The positive Phase 3 data from the LITESPARK-005 trial represent a significant milestone for the treatment of advanced RCC. WELIREG is the first HIF-2α inhibitor therapy to show positive results in patients following immune checkpoint and anti-angiogenic therapies. These findings support Merck’s dedication to advancing research for patients with difficult-to-treat cancers and highlight the potential of WELIREG to improve outcomes. The results from the LITESPARK clinical development program, including Phase 2 studies, further emphasize the efficacy of WELIREG in treating advanced RCC.
