Merck Announces Positive Data from Phase 3 Studies of V116
Merck announces positive data from multiple phase 3 studies of V116, an investigational, adult-specific 21-valent pneumococcal conjugate vaccine
Overview
Merck, known as MSD outside of the United States and Canada, announced positive data from multiple phase 3 studies evaluating V116, the company’s investigational, adult-specific 21-valent pneumococcal conjugate vaccine, at the 13th Meeting of the International Society of Pneumonia and Pneumococcal Diseases (ISPPD) in Cape Town, South Africa.
V116’s Immunogenicity
Across the clinical studies presented, V116 was shown to be immunogenic for all 21 serotypes covered by the vaccine in a variety of adult populations, including
(a) those who had not previously received a pneumococcal vaccine (pneumococcal vaccine-naïve),
(b) those who had previously received a pneumococcal vaccine (pneumococcal vaccine-experienced) and
(c) those with an increased risk of pneumococcal disease, including people living with human immunodeficiency virus (HIV).
V116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116 in all STRIDE studies presented at the meeting.
Words from Merck’s Advisory Member
Invasive pneumococcal disease and pneumococcal pneumonia can cause serious illness, especially in older adults and those with immunocompromising conditions,” said Dr. Walter Orenstein, professor emeritus of medicine, epidemiology, global health and paediatrics at Emory University and member of Merck’s Scientific Advisory Committee. “These positive data demonstrate the potential for V116 to address an unmet need in adult pneumococcal disease prevention.
Key Findings from the Studies Include:
In pneumococcal vaccine-naïve adults 50 years of age and older (STRIDE-3 sub-group), V116 was immunogenic for all 21 serotypes across the studied age groups (50–64, 65–74 and 75–84 years).
It was assessed by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at Day 30.
In pneumococcal vaccine-experienced adults 50 years of age and older (STRIDE-6), V116 elicited comparable immune responses for the serotypes shared with PCV15 (pneumococcal 15-valent conjugate vaccine) or PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) and higher immune responses for the serotypes covered by V116 only, regardless of the previous pneumococcal vaccine received or time since prior pneumococcal vaccination, as assessed by serotype-specific OPA GMTs at Day 30.
In adults 18 years of age and older living with HIV (STRIDE-7), V116 elicited comparable immune responses to PCV15+PPSV23 for all 13 shared serotypes and higher immune responses for the eight serotypes covered by V116 only, as assessed by serotype-specific OPA GMTs and Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at Day 30; Across all presented studies, V116 demonstrated a safety profile comparable to the studied comparators, including PCV20 (pneumococcal 20-valent conjugate vaccine), PCV15 and PPSV23.
Words from CMO: Merck Laboratories
The extensive data presented this week reaffirm our confidence in the potential clinical value V116 could provide to a range of adult populations,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “We are encouraged by the results of these studies showing that V116 has generated immune responses to the serotypes responsible for the majority of adult invasive pneumococcal disease.
PNEUMO
In addition to phase 3 clinical data on V116, Merck also presented preliminary data from the real-world evidence study in the US, Pneumococcal Pneumonia Epidemiology, Urine Serotyping, and Mental Outcomes (PNEUMO).
It was found that among 2,065 adults 50 years of age and older hospitalized with community-acquired pneumonia between 2018 and 2022, 242 pneumococcal serotypes were detected. Of these serotypes, approximately 84% were covered by V116.
One fourth (approximately 25%) of the detected serotypes were covered only by V116 and not by PCV15 or PCV20.
Results from the PNEUMO study support that the serotypes in V116 account for the majority of pneumococcal disease (including invasive and non-invasive) in adults 50 years of age and older.
These data are consistent with CDC surveillance data for invasive pneumococcal disease from 2018-2021, which show that V116 covers serotypes responsible for approximately 83% of invasive pneumococcal disease, including the eight serotypes unique to V116 which are responsible for approximately 30% of invasive pneumococcal disease in individuals 65 years of age and older.
Several submissions
Several of the studies presented at ISPPD were included in the filing submission to the US Food and Drug Administration (FDA).
The FDA granted V116 priority review with a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024.
If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults.
About V116
V116 is an investigational, 21-valent pneumococcal conjugate vaccine in Phase 3 development for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in the adult population.
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.
The serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in individuals 65 years of age and older, based on the same CDC data.
V116 is designed to be administered as a single dose to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults.
V116 Phase 3 Programme
The V116 phase 3 programme includes multiple studies, including STRIDE-3 (NCT05425732), STRIDE-4 (NCT05464420), STRIDE-5 (NCT05526716), STRIDE-6 (NCT05420961), STRIDE-7 (NCT05393037), STRIDE-8 (NCT05696080), STRIDE-9 (NCT05633992) and STRIDE-10 (NCT05569954).
Pneumococcal Disease
Pneumococcal disease is an infection caused by a bacteria called Streptococcus pneumoniae.
There are more than 100 different types (referred to as serotypes) of pneumococcal bacteria, which can affect adults differently than children.
Certain serotypes threaten to put more people at risk for invasive pneumococcal illnesses, such as bacteremia (infection in the bloodstream); bacteremic pneumonia (pneumonia with bacteremia); and meningitis (infection of the coverings of the brain and spinal cord), as well as non-invasive pneumonia (when pneumococcal disease is confined to the lungs).
While healthy adults can suffer from pneumococcal disease, patient populations particularly vulnerable to infection include older adults and those with certain chronic or immunocompromising health conditions, such as heart disease, lung disease and liver disease.
Mortality from invasive pneumococcal disease is highest among adults 50 years of age and older.
Merckon Contribution on Pneumococcal Disease
Merck has been at the forefront of pneumococcal disease prevention through vaccination for more than four decades and remains committed to helping to protect people of all ages from this disease.
Merck’s ongoing pneumococcal vaccine development programme is designed to provide options that address the specific needs of different populations, including infants and children, healthy adults and at-risk sub-groups.
This approach recognizes that disease burden in pediatric and adult populations is often driven by different bacterial strains, or serotypes, and aims to address unmet needs by offering vaccine options that target serotypes posing the greatest global risk to each population.