PREVYMIS showed non-inferior efficacy and more favorable safety profile compared to standard of care; results presented at IDWeek 2022
Separate Phase 3 study evaluating 200 days of therapy with PREVYMIS in HSCT recipients at high risk of late clinically significant CMV infection recently completed, meeting its primary endpoint
RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today the presentation of findings from a Phase 3 clinical trial that assessed safety and efficacy of PREVYMIS™ (letermovir) compared to valganciclovir for cytomegalovirus (CMV) prophylaxis in 601 adult kidney transplant recipients at high risk for CMV disease (D+/R-). At 52 weeks following kidney transplant, trial results met the primary endpoint demonstrating that PREVYMIS was effective and non-inferior to valganciclovir for preventing CMV disease -- 10.4% (n=30) of participants who received PREVYMIS developed CMV disease versus 11.8% (n=35) of participants on valganciclovir (stratum adjusted difference = -1.4, [95% CI, -6.5, 3.8]). In a pre-specified safety analysis, PREVYMIS-treated participants had significantly less myelotoxicity, as measured by rates of leukopenia or neutropenia, compared to valganciclovir-treated participants; 26.0% (n=76) versus 64.0% (n=190), (95% CI, -45.1, -30.3; p-value