In September 2024, Merck (MSD) announced positive top-line results from its pivotal Phase III trial evaluating the company’s 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL 9, in young males in Japan. The trial met its primary and secondary endpoints, proving 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 to a placebo. Merck will share the data with regulatory authorities in Japan and other countries to support licensure for use in males.
V503-064
V503-064 is a Phase III, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, and efficacy of GARDASIL 9 (V503) in preventing HPV-related anogenital persistent infection in Japanese males between the ages of 16 and 26. It enrolled 1,059 participants. 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.
Dr Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, highlighted that “a decade after the first approval of GARDASIL 9, Merck continues to evaluate this important vaccine in additional patient populations”. Dr Barr emphasised Merck’s commitment to “helping prevent certain HPV-related cancers through broad and equitable access globally”.
“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’s clinical development programme evaluating GARDASIL 9 in males 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.
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