This article is more than 5 years old. Information may no longer be current.
Letermovir reaches primary endpoint in phase 3 trial
Click Here to Manage Email Alerts
Today, Merck announced that letermovir met its primary endpoint in a phase 3 trial evaluating the safety and efficacy of the drug for the prevention of cytomegalovirus infection in seropositive adult recipients of allogeneic hematopoietic stem cell transplants, according to a press release.
Letermovir is part of a new class of non-nucleoside cytomegalovirus (CMV) inhibitors that prevents viral replication by targeting the viral terminase complex. The drug has been granted fast track designation by the FDA, and orphan designation by the FDA, the European Medicines Agency and the Japanese Ministry of Health, Labour and Welfare for the prevention of CMV infection in at-risk populations.
For the randomized, multicenter, placebo-controlled trial, researchers administered letermovir once-daily as either an oral tablet or IV formulation. They initiated therapy up to 28 days after allogeneic hematopoietic stem cell transplantation and continued for approximately 100 days. The primary outcome was the percentage of patients with CMV infection through 24 weeks post-transplant.
“There is an unmet need for therapeutic options in the prevention of CMV infection in high-risk allogeneic hematopoietic stem cell transplant recipients,” Roy Baynes, MD, PhD, senior vice president of clinical development Merck Research Laboratories, said in the release. “Merck is pleased this pivotal Phase 3 study with letermovir met its primary endpoint. We thank the patients and families who participated in this study and we look forward to presenting results at a future scientific meeting.”
Disclosure: Baynes is senior vice president of clinical development for Merck Research Laboratories.