- LITESPARK-022 is the second positive Phase 3 study for WELIREG in RCC.
- KEYTRUDA and WELIREG showed significant DFS improvement over KEYTRUDA with placebo.
- The trial will continue to evaluate overall survival as a secondary endpoint.
- Safety profiles were consistent with previous studies for the individual therapies.
Study Overview
The Phase 3 LITESPARK-022 trial evaluated the combination of KEYTRUDA (pembrolizumab) and WELIREG (belzutifan) in patients with clear cell renal cell carcinoma (RCC) following nephrectomy. This combination showed a statistically significant and clinically meaningful improvement in disease-free survival (DFS) compared to KEYTRUDA with placebo.
Trial Significance
This is the second positive Phase 3 study for WELIREG as part of a combination regimen in RCC. The trial will continue to assess overall survival (OS) as a key secondary endpoint, providing further insights into the long-term benefits of the treatment.
Safety and Future Plans
The safety profiles of KEYTRUDA and WELIREG in this trial were consistent with those observed in previous studies for the individual therapies. The results will be presented at a future medical meeting and shared with regulatory authorities worldwide.
