October 19, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Kenilworth, NJ – Merck & Co. announced positive results for its Phase III trial of letermovir in patients with cytomegalovirus (CMV) infection.
Letermovir is a once-daily antiviral that belongs in a new class of non-nucleoside CMV inhibitors (3,4 dihydro-quinazolines). It inhibits viral replication by targeting the viral terminase complex. It has been granted orphan designation by the European Medicines Agency, the U.S. Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour and Welfare. The FDA also granted it Fast Track designation.
The drug was evaluated in adult patients 18 years or older who were CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT). The primary endpoint met was percentage of participants with clinically-significant CMV infection through 24 weeks after transplant.
“There is an unmet need for therapeutic options in the prevention of CMV infection in high-risk allogeneic hematopoietic stem cell transplant recipients,” said Roy Baynes, senior vice president of clinical development for Merck Research Laboratories , in a statement. “Merck is pleased this pivotal Phase III 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.
Merck acquired global rights from AiCuris GmbH & Co. KG in 2012.
Secondary endpoints included time to onset of clinically-significant CMV infection, percentage of participants with clinically-significant CMV infection and disease at different time frames, and others. No specific results have been released.
This is good news for Merck. In December, Chimerix indicated that its Phase III SUPPRESS trial of brincidofovir in patients undergoing HCT didn’t achieve its primary endpoint of a clinically significant reduction of CMV invention through week 24 after transplant. Brincidofovir is an oral nucleotide analog that had shown antiviral activities against all five families of DNA viruses that hit humans, including herpesvirus and adenovirus.
Merck’s having a good month. On October 9, the company presented data at the European Society for Medical Oncology regarding its immuno-oncology drug Keytruda in non-small cell lung cancer (NSCLC). Keytruda, a PD-1 inhibitor, showed that patients lived 40 percent longer on Keytruda than those on traditional chemotherapy, (docetaxel).
“These findings—which show superior survival with longer follow-up across patients with PD-L1 expression (tumor proportion score of one percent or more), as well as improved quality of life—point to Keytruda as a durable treatment option for many previously treated patients with advanced non-small cell lung cancer,” said Roy Herbst, professor of medicine and chief of medical oncology, Yale Cancer Center, in a statement.
Merck is competing with Bristol-Myers Squibb and its own immuno-oncology drug, Opdivo. It is hoping that the FDA will approve it as a first-line treatment for lung cancer by mid-December. It has already received the nod for lung cancer in patients whose disease grew worse after treatment.
In August, Opdivo failed to meet endpoints in a Phase III trial as a monotherapy for previously untreated advanced NSCLC patients. Bristol-Myers Squibb indicated that the drug did not show progression-free survival (PFS) in patients that expressed 5 percent or more of PD-L1. Keytruda, on the other hand, showed expression in the patient population with 50 percent PD-1.
