Yesterday, Merck announced the FDA has accepted for priority review a new Biologics License Application (BLA) for V116, the company’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024.
“Invasive pneumococcal disease poses a greater risk to older adults or those with weakened immune systems, in part due to disease-causing serotypes not covered by currently licensed pneumococcal conjugate vaccines,” Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said in a statement. “If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed to address the serotypes that cause most adult invasive pneumococcal disease. We look forward to discussing the data that support our filing with the FDA and are working with urgency to bring this potential new preventative measure to adult patients.”
According to earlier reporting by Contagion, topline results from the company’s phase 3 trial, STRIDE-3, included:
- In adults 50 years of age and older (cohort 1), V116 elicited non-inferior immune responses compared to PCV20 for all 10 serotypes common to both vaccines as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at Day 30.
- Immune responses elicited by V116 were superior for 10 of 11 serotypes included in V116 but not in PCV20 as measured by OPA GMTs at Day 30 and the proportions of patients with a greater than or equal to four-fold increase in OPA from Day 1 to Day 30.
- In adults 18 to 49 years of age (cohort 2), V116 elicited non-inferior immune responses (immunobridged) compared to adults 50 to 64 years of age, as assessed by serotype‐specific OPA GMTs 30 days post-vaccination.
- Across both cohorts, V116 had a safety profile comparable to PCV20.
V116 demonstrated statistically significant immune responses in both vaccine-naive adults and those previously vaccinated in their 2 phase 3 trials. V116 is specifically designed to address Streptococcus pneumoniae serotypes predominantly responsible for adult pneumococcal disease, including eight unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B, which account for approximately 30% of adult disease, according to CDC data from 2018-2021.
What You Should Know
The FDA has accepted Merck's Biologics License Application (BLA) for V116, an investigational 21-valent pneumococcal conjugate vaccine designed for adults.
V116 covers 21 serotypes and aims to prevent invasive pneumococcal disease and pneumococcal pneumonia in adults. The phase 3 trial, STRIDE-3, showed promising results.
V116 is specifically designed to address Streptococcus pneumoniae serotypes that are a major cause of adult pneumococcal disease.
Overall, the serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in individuals 65 years of age and older, based on CDC data.
“Invasive forms of pneumococcal disease can cause serious and sometimes life-threatening complications, such as pneumococcal pneumonia, pneumococcal meningitis and bacteremia, especially for older or immunocompromised adults,” said Sady Alpizar, MD, Clinical Research Trials of Florida, and a principal investigator of the study. “These encouraging results demonstrate that V116 has the potential to help prevent invasive pneumococcal disease among vulnerable populations.”
FDA Grants Priority Review to Merck’s New Biologics License Application for V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults. Merck press release. December 19, 2023 https://www.merck.com/news/fda-grants-priority-review-to-mercks-new-biologics-license-application-for-v116-an-investigational-21-valent-pneumococcal-conjugate-vaccine-specifically-designed-to-protect-adults/