HQ Team
September 11, 2024: Merck & Co., announced it has met its primary and secondary goals during the end-stage trials of its human papillomavirus (HPV) vaccine in Japanese males aged between 16-26 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 nine types of HPV compared with a placebo,” according to a Merck statement.
The vaccine was in the third and final stage of clinical trials.
“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.”
Anal, oral sex
HPV is a group of more than 200 related viruses, some of which are spread through vaginal, anal, or oral sex, according to the National Cancer Institute.
Sometimes HPV infections are not successfully controlled by your immune system. When a high-risk HPV infection persists for many years, it can lead to cell changes that, if untreated, may get worse over time and become precancerous and then cancerous.
There are 12 high-risk HPV types: HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59. Two of these, HPV 16 and HPV 18, are responsible for most HPV-related cancers.
Merck’s investigational vaccine met the primary efficacy objective was to demonstrate a reduction in the incidence of HPV 6/11/16/18-related 6-month anogenital persistent infection.
The secondary efficacy objective was to demonstrate a reduction in the incidence of HPV 31/33/45/52/58-related 6-month anogenital persistent infection. The study enrolled 1,059 participants in more than 20 locations in Japan, including Tokyo.
Apply for regulator’s nod
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 III trial evaluating efficacy in preventing HPV oral persistent infection to support effectiveness against HPV-related oropharyngeal and other head and neck cancers, according to the statement.
In May 2020, the nonavalent vaccine Gardasil 9 was approved in Japan. This vaccine successfully prevents the infection of nine types (HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58), which account for about 90% of HPV infections that cause cervical cancer, according to the Japanese Society of Gynecologic Oncology.
