Merck Reports Positive Phase 3 Results for GARDASIL®9 in Japanese Males

Merck, also known as MSD outside the United States and Canada, has announced promising top-line results from its pivotal Phase 3 trial (V503-064) evaluating the 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL® 9, among Japanese males aged 16 to 26. The study achieved its main objectives, demonstrating that a 3-dose regimen of GARDASIL 9 significantly lowered the combined incidence of anogenital persistent infections caused by nine types of HPV compared to a placebo.

Dr. Eliav Barr, senior vice president and head of global clinical development at Merck Research Laboratories, stated that these findings build on the clinical efficacy of GARDASIL 9 in preventing persistent HPV infections in males. He emphasized Merck’s commitment to facilitating global access to this crucial vaccine to help prevent HPV-related cancers and diseases.

Merck intends to present these data to regulatory authorities in Japan and other countries to support the licensure of GARDASIL 9 for use in males. The complete study results will be shared at an upcoming scientific congress. Additionally, there is an ongoing confirmatory Phase 3 trial to determine the vaccine's efficacy in preventing HPV-related oropharyngeal and other head and neck cancers (NCT04199689).

The V503-064 Phase 3 trial is a double-blind, placebo-controlled study (NCT04635423) designed to assess the safety, tolerability, and effectiveness of GARDASIL 9 in preventing HPV-related anogenital persistent infections in Japanese males aged 16 to 26. Commercially, GARDASIL 9 is marketed as SILGARD 9 in Japan. The study’s primary objective was to show a decrease in the incidence of six-month anogenital persistent infections due to HPV types 6, 11, 16, and 18. The secondary objective was to reduce the incidence of six-month anogenital persistent infections caused by HPV types 31, 33, 45, 52, and 58. A total of 1,059 participants were enrolled in the study.

In the United States, GARDASIL 9 is approved for use in females aged 9 through 45 for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal, and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58. It is also approved for preventing genital warts caused by HPV types 6 and 11, as well as precancerous lesions due to these HPV types. For males aged 9 through 45, GARDASIL 9 is indicated for preventing anal, oropharyngeal, and other head and neck cancers, along with genital warts caused by specified HPV types.

It is important to note that GARDASIL 9 does not replace the need for regular screening for cervical, vulvar, vaginal, anal, oropharyngeal, and other head and neck cancers as recommended by healthcare providers. The vaccine does not protect against HPV types not included in the vaccine or against HPV types to which a person has already been exposed through sexual activity. Additionally, not all cancers of the vulva, vagina, anus, oropharynx, and head and neck are caused by HPV, and GARDASIL 9 only offers protection against those caused by specific HPV types.

The vaccine is not a treatment for pre-existing genital lesions or cancers and may not provide protection for all recipients. Hypersensitivity reactions, including severe allergic responses to yeast or a previous dose of GARDASIL 9 or GARDASIL®, are contraindications for the vaccine. Common adverse reactions include injection-site pain, swelling, erythema, and headaches in both males and females. The vaccine’s duration of immunity from a 2-dose schedule has not been determined.

GARDASIL 9 is administered intramuscularly in the deltoid or anterolateral thigh area. For individuals between 9 to 14 years old, a 2-dose or 3-dose schedule can be used, while those aged 15 to 45 should follow a 3-dose schedule.

Merck, a global biopharmaceutical company, focuses on innovative health solutions to improve lives worldwide, employing cutting-edge science for over 130 years. Their mission includes advancing the prevention and treatment of diseases and fostering a diverse, inclusive global workforce to promote a sustainable and healthy future for all communities.

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