Merck reports ‘positive’ results from Phase 3 LITESPARK-022 trial

Merck (MRK) announced positive topline results from the Phase 3 LITESPARK-022 trial in patients with clear cell renal cell carcinoma following nephrectomy. In this study, KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with WELIREG, Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha inhibitor, given in the adjuvant setting, demonstrated a statistically significant and clinically meaningful improvement in disease-free survival, the study’s primary endpoint, compared to KEYTRUDA in combination with placebo. The trial will continue to evaluate overall survival, a key secondary endpoint. 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.