Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced positive top-line results from its pivotal Phase 3 trial (V503-064) evaluating the company's 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL9 (Human Papillomavirus 9-valent Vaccine, Recombinant) in Japanese males ages 16 to 26 years. 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 GARDASIL9, 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 GARDASIL 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 3 trial evaluating efficacy in preventing HPV oral persistent infection to support effectiveness against HPV-related oropharyngeal and other head and neck cancers (NCT04199689).