Merck’s KEYTRUDA And WELIREG Combination Delivers Significant DFS Benefit In Adjuvant RCC Phase 3 Trial

Merck has announced positive topline results from its Phase 3 LITESPARK-022 trial evaluating the combination of KEYTRUDA® (pembrolizumab) and WELIREG® (belzutifan) in patients with clear cell renal cell carcinoma (RCC) following nephrectomy. The combination, tested in the adjuvant setting, achieved a statistically significant and clinically meaningful improvement in disease-free survival (DFS) compared with KEYTRUDA plus placebo, meeting the study’s primary endpoint. The trial will continue to assess overall survival (OS), a key secondary endpoint, to determine long-term patient benefit.

"KEYTRUDA monotherapy given in the adjuvant setting remains an important treatment choice for patients with renal cell carcinoma at an increased risk of recurrence following surgery and is the only approved option to have significantly improved disease-free survival and overall survival in this disease setting. Still, many of these patients do remain at risk of recurrence and continue to represent an unmet need," said Dr. M. Catherine Pietanza, vice president, global clinical development, Merck Research Laboratories. “These encouraging results of KEYTRUDA in combination with WELIREG from LITESPARK-022 demonstrate the potential to provide additional treatment options for those most in need.”

The safety profile of the KEYTRUDA and WELIREG regimen remained consistent with that observed in earlier studies of each therapy, and no new safety signals were identified. Merck plans to present the detailed findings at an upcoming medical meeting and engage with regulatory authorities worldwide. The results highlight the potential of this novel combination to enhance outcomes in the post-surgical, adjuvant treatment landscape of RCC, where recurrence remains a significant concern.

Merck’s KEYTRUDA is already approved for adjuvant RCC treatment in major markets including the U.S., EU, Canada, and Japan, based on the KEYNOTE-564 trial, while WELIREG is approved in over 40 countries for advanced RCC following prior immunotherapy and VEGF-TKI treatments. The company continues to strengthen its RCC clinical development program, leveraging multiple approved therapies across both adjuvant and advanced disease settings to expand treatment options for patients.