Merck Reports Positive Results from Phase 3 Trial Evaluating Efficacy and Safety Of Gardasil 9

Merck reports positive top-line results from phase 3 trial evaluating efficacy and safety of Gardasil 9 in Japanese males

Overview

Merck, known as MSD outside of the United States and Canada, announced positive top-line results from its pivotal phase 3 trial (V503-064) evaluating the company’s 9-valent Human Papillomavirus (HPV) vaccine, Gardasil 9 (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.

Statement from Merck Research Laboratories

• 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 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.

Upcoming Presentation of Results

• 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 programme 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 ).

V503-064 Trial

• V503-064 is a phase 3, 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

• 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.

About Gardasil 9 Vaccine

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: Indication

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.

About the Cancer Indications

• The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. 
• Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Important Facts Related to Gardasil 9

• Gardasil 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider.
• Gardasil 9 has not been demonstrated to provide protection against diseases caused by: HPV types not covered by the vaccine; HPV types to which a person has previously been exposed through sexual activity.
• Gardasil 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.

Vaccination with Gardasil 9 may not result in protection in all vaccine recipients.

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