Positive top-line results from phase III trial evaluating efficacy and safety of Gardasil 9 in Japanese males

The trial met its primary and secondary endpoints demonstrating that administration of a 3-dose regimen of Gardasil 9 reduced the combined incidence of anogenital persistent infection caused by 9 types of HPV compared with a placebo. “ A decade after the first approval of Gardasil 9, Merck continues to evaluate this important vaccine in additional patient populations and remains committed to helping prevent certain HPV-related cancers through broad and equitable access globally,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “These data build on the clinical efficacy of Gadasil 9 for the prevention of persistent infection in males and can potentially make a significant impact in addressing the global burden of certain HPV-related cancers and diseases.”

Merck plans to share these data with regulatory authorities in Japan and other countries around the world to support licensure for use in males. The full results also will be presented at an upcoming scientific congress. The clinical development program evaluating GARDASIL 9 in males also includes an ongoing confirmatory Phase III trial evaluating efficacy in preventing HPV oral persistent infection to support effectiveness against HPV-related oropharyngeal and other head and neck cancers.
About V503-064; V503-064 is a Phase III, double-blind, placebo-controlled clinical study ( NCT04635423 ) to evaluate the safety/tolerability and efficacy of Gardasil 9 (V503) in preventing HPV-related anogenital persistent infection in Japanese males 16 to 26 years of age. Gardasil 9 is commercialized in Japan under the name Silgard 9. The primary efficacy objective was to demonstrate reduction in the incidence of HPV 6/11/16/18-related 6-month anogenital persistent infection. The secondary efficacy objective was to demonstrate reduction in the incidence of HPV 31/33/45/52/58-related 6-month anogenital persistent infection. The study enrolled 1,059 participants.