Merck's PREVYMIS Efficacious in Phase 3 for Preventing Cytomegalovirus AFter Transplant

 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

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 <0.0001). The findings from this trial were presented during a late-breaking oral session at the IDWeek Annual Meeting (Abstract # LB2307). Merck plans to submit a supplemental new drug application (sNDA) with these data to the U.S. Food and Drug Administration (FDA) by the end of this year.

PREVYMIS is a first-in-class antiviral agent that was approved by the U.S. FDA in 2017 and is indicated for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). PREVYMIS is contraindicated in patients receiving pimozide or ergot alkaloids. Increased pimozide concentrations may lead to QT prolongation and torsades de pointes. Increased ergot alkaloids concentrations may lead to ergotism. PREVYMIS is contraindicated with pitavastatin and simvastatin when co-administered with cyclosporine. Significantly increased pitavastatin or simvastatin concentrations may lead to myopathy or rhabdomyolysis.

“CMV disease is an important cause of morbidity and mortality in kidney transplant recipients. Valganciclovir has been the most commonly used drug for CMV prophylaxis in this setting, but myelotoxicity (especially neutropenia and leukopenia) is an important limitation of this drug. Myelotoxicities can be difficult to manage in patients who are already receiving complex treatment regimens with other drugs that also have bone marrow suppressive effects,” said Dr. Ajit P. Limaye, director, Solid Organ Transplant Infectious Disease Program at University of Washington School of Medicine. “I was excited to see these trial results that showed that the efficacy of PREVYMIS for prevention of CMV disease in kidney transplant patients was similar to the current standard of care treatment (valganciclovir), but with significantly less toxicity.”

https://www.marketscreener.com/quote/stock/MERCK-CO-INC-13611/news/Merck-s-PREVYMIS-trade-Demonstrates-Efficacy-in-Phase-3-Study-for-Prevention-of-Cytomegalovirus-Dis-42065345/