Results from multiple Phase 3 trials of V116
and a real-world evidence study of pneumococcal serotypes presented
at the 13th Meeting of the International Society of Pneumonia and
Pneumococcal Diseases
If approved, V116 would be the first
pneumococcal conjugate vaccine specifically designed for
adults
Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, today 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.
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 those who had not
previously received a pneumococcal vaccine (pneumococcal
vaccine-naïve), those who had previously received a pneumococcal
vaccine (pneumococcal vaccine-experienced) and 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.
“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
pediatrics 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), as
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.
“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.”
In addition to Phase 3 clinical data on V116, Merck also
presented preliminary data from the real-world evidence study in
the U.S., Pneumococcal Pneumonia Epidemiology, Urine Serotyping,
and Mental Outcomes (PNEUMO), which 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 of the studies presented at ISPPD were included in the
filing submission to the U.S. 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. An overview of the V116
late-stage development program is available here.
Summary of Findings from Select Studies Presented at
ISPPD
Data from STRIDE-3 Sub-group (Abstract #379) The
sub-group analysis of the pivotal STRIDE-3 (NCT05425732) trial
evaluated immunogenicity in adults 50 years of age and older who
had not previously received a pneumococcal vaccine (Cohort 1) by
age groups (50–64, 65–74 and 75–84 years) (n=2,362). Results found
that V116 was immunogenic for all 21 vaccine serotypes across the
studied age sub-groups, as assessed by serotype-specific OPA GMTs
30 days post-vaccination. There was a slight downward trend in
immune responses in adults 65–74 years of age and 75 years of age
and older compared to adults 50–64 years of age. V116 had a safety
profile comparable to PCV20. Results from the STRIDE-3 trial were
presented at the World Vaccine Congress West Coast in November
2023.
Data from STRIDE-6 and STRIDE-6 Sub-group (Abstracts #353 and
#520) STRIDE-6 (NCT05420961) is a Phase 3 trial investigating
V116 in adults 50 years of age and older who had previously
received a pneumococcal vaccine at least one year prior (n=712).
Participants were enrolled based on previous pneumococcal
vaccination with PPSV23, PCV15, PCV13 (pneumococcal 13-valent
conjugate vaccine), PPSV23+PCV13, PCV13+PPSV23 or PCV15+PPSV23, and
received either V116, PCV15 or PPSV23.
Results showed that V116 was immunogenic across all cohorts, as
assessed by OPA GMTs 30 days post-vaccination, and that V116
elicited comparable immune responses to the serotypes also covered
by PCV15 and PPSV23 and higher immune responses for the serotypes
covered only by V116. A STRIDE-6 sub-group analysis evaluating
immunogenicity across all cohorts by time since prior pneumococcal
vaccination found that V116 elicited comparable immune responses
regardless of time since prior pneumococcal vaccination, including
more than 10 years post-vaccination with PPSV23 (n=56), and 5–9
years post-vaccination with either PPSV23 or other pneumococcal
vaccines (n=208). In this study, V116 had a safety profile
comparable to both PCV15 and PPSV23.
Data from STRIDE-7 (Abstract #1093) STRIDE-7
(NCT05393037) is a Phase 3, double-blind study of V116 in adults
living with HIV (n=304). Results showed that V116 was immunogenic
for all serotypes covered by the vaccine, as assessed by OPA GMTs
and IgG GMCs 30 days post-vaccination. V116 elicited comparable
immune responses to the comparator, PCV15+PPSV23, for all 13 shared
serotypes and higher immune responses for the eight serotypes
covered only by V116. Fewer participants experienced adverse events
(AEs) with V116 (71.6%) compared with PCV15+PPSV23 (91%), primarily
due to fewer injection-site AEs.
Data from STRIDE-9 (Abstract #1085) STRIDE-9
(NCT05633992) is a Phase 3, randomized, double-blind,
active-comparator controlled study, which investigated V116 in
Japanese adults 65 years of age and older who had not previously
received a pneumococcal vaccine (n=450). Serotype-specific OPA
responses were measured at baseline and 30 days post-vaccination
and results demonstrated that V116 elicited noninferior immune
responses for the 12 serotypes shared with PPSV23 and serotype 15B,
(which is included in PPSV23 but not included in V116). V116 also
elicited higher immune responses for the serotypes only covered by
V116 and not PPSV23. V116 also had a comparable safety profile to
PPSV23.
Data from PNEUMO U.S. Serotype Distribution Study (Abstract
#308) The PNEUMO U.S. study evaluated pneumococcal serotype
distribution among adults 50 years of age and older hospitalized
with community-acquired pneumonia (n=2,065), one of the
non-invasive forms of pneumococcal disease, between 2018 and 2022
in three hospitals in Tennessee and Georgia. Urine samples from
patients were evaluated for antigens from 30 pneumococcal serotypes
using novel serotype-specific urinary antigen detection (SSUAD)
assays (all serotypes in PCV15, PCV20 and V116 are included except
15B). Among the 242 serotypes detected by SSUAD assays,
approximately 84% were covered by V116, compared to approximately
64% covered by PCV20. One fourth (approximately 25%) of the
detected serotypes were covered by V116 only and not by PCV15 or
PCV20.
Additional Clinical Study Results Presented at ISPPD
(Abstract #382 and #355) Data from Phase 3 clinical studies
STRIDE-4 (NCT05464420) and STRIDE-5 (NCT05526716) were also
presented at ISPPD.
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.
The V116 Phase 3 program 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).
About 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.
Merck’s Commitment to Pneumococcal Disease Protection
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 program
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. To learn more
about Merck’s pipeline, visit www.merck.com.
About Merck At Merck, known as MSD outside of the United
States and Canada, we are unified around our purpose: We use the
power of leading-edge science to save and improve lives around the
world. For more than 130 years, we have brought hope to humanity
through the development of important medicines and vaccines. We
aspire to be the premier research-intensive biopharmaceutical
company in the world – and today, we are at the forefront of
research to deliver innovative health solutions that advance the
prevention and treatment of diseases in people and animals. We
foster a diverse and inclusive global workforce and operate
responsibly every day to enable a safe, sustainable and healthy
future for all people and communities. For more information, visit
www.merck.com and connect with us on X (formerly Twitter),
Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway,
N.J., USA This news release of Merck & Co., Inc., Rahway,
N.J., USA (the “company”) includes “forward-looking statements”
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