Data from the BROADEN and PROGRESS studies were presented at the International Papillomavirus Conference 2024 in Edinburgh, UK, from November 12 to 15.
New clinical and real-world data have been announced for the 9-valent human papillomavirus (HPV) vaccine (Gardasil; Merck), highlighting more robust support for the vaccine's efficacy regarding HPV-related cancer and diseases. Data from the BROADEN and PROGRESS trials (NCT04199689) were presented at the International Papillomavirus Conference 2024 in Edinburgh, Scotland, from November 12 to 15.1
“These data support the value of adult vaccination and strengthen our understanding that disease-causal HPV infection can happen later in life, reinforcing the importance of HPV vaccination for both females and males beginning at age 9,” Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories, said in a news release. “While historically the HPV vaccination conversation has focused on preventing certain HPV-related cervical cancers in women, we also continue to see the growing incidence of HPV-related oropharyngeal and other head and neck cancers, particularly in men.”1
Barr stated that there are approximately 666,000 new diagnoses of HPV-related cancers for men and women globally every year. According to the CDC, more than 42 million Americans are infected with a type of HPV, with 13 million Americans being infected every year. The types of HPV include non-oncogenic and oncogenic, which are wart-causing and cancer-causing, respectively. The CDC recommends 2 doses of an HPV vaccine at 11 or 12 years of age. Those who get their first dose on or after turning 15 will need 3 doses.1,2
Merck presented 3 oral abstracts and 5 poster sessions based on the clinical trial data, with 4 abstracts analyzing data on HPV-related cancer diseases in women and men and 4 analyzing data on oral HPV infection and HPV-related head and neck cancer in women and men.1
The BROADEN study was an observational study of pre-treatment tumor tissue from patients with a first primary diagnosis of oropharynx, hypopharynx, larynx, nasopharynx, and oral cavity cancers. It included 4492 patients from 63 hospitals and 4023 samples. Patients were predominantly male with a mean age of 63.6 years, according to the abstract information.3
Trial Name: Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)
ClinicalTrials.com ID: NCT04199689
Sponsor: Merck Sharp & Dohme LLC
Completion Date (Estimated): September 2026
For the PROGRESS study, investigators included 7877 individuals. Patients received regular dental check-ups, with data on clinical characteristics. Further, patients completed self-reported study questionnaires as well as an oral rinse and gargle specimen for detection of HPV, according to the study authors. Patients were given either the vaccine or a placebo at day 1, month 2, and month 6. Investigators evaluated the incidence of HPV-related oral infection up to 42 months, with secondary outcomes including geometric mean titers of HPV type antibodies, and adverse events.4,5
