Merck known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 LITESPARK-022 trial in patients with clear cell renal cell carcinoma (RCC) following nephrectomy. In this study, KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with WELIREG (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, given in the adjuvant setting, demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS), the study’s primary endpoint, compared to KEYTRUDA in combination with placebo. The trial will continue to evaluate overall survival (OS), a key secondary endpoint.
"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 profiles of KEYTRUDA plus WELIREG in this trial were overall consistent with those observed in previously reported studies for the individual therapies. Results will be presented at a future medical meeting and shared with regulatory authorities worldwide.
KEYTRUDA is approved for the adjuvant treatment of certain patients with RCC in the U.S., Canada, European Union (EU), Japan and other countries worldwide based on data from KEYNOTE-564.
WELIREG is approved in over 40 countries including the U.S., Canada, EU, and Japan for the treatment of adult patients with advanced RCC following a PD-1/PD-L1 inhibitor and 1-2 VEGF-TKIs based on results from the Phase 3 LITESPARK-005 trial.
Merck has an industry-leading clinical development program in RCC, leveraging multiple approved therapeutic options across multiple settings, including adjuvant and advanced disease.
