Merck announced positive top-line results from its Phase 3 trial (V503-064) evaluating Gardasil 9 in Japanese males ages 16 to 26 years. The trial demonstrated that 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.
The V503-064 study is a Phase 3, double-blind, placebo-controlled clinical study to evaluate the safety/tolerability and efficacy of GARDASIL 9 in preventing HPV-related anogenital persistent infection in Japanese males 16 to 26 years of age. The study enrolled 1,059 participants.
Efficacy Objectives
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.
Future Plans
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).
About Gardasil 9
GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.
GARDASIL 9 is indicated in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.
"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.
