The 21 serotypes covered by V116 are
responsible for approximately 83% of invasive pneumococcal disease
in individuals 65 years of age and older, according to CDC data
from 2018-2021
Results from Phase 3 trial, STRIDE-3, to be
presented at World Vaccine Congress West Coast
Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, today announced results from STRIDE-3, a Phase 3 trial
evaluating V116, the company’s investigational 21-valent
pneumococcal conjugate vaccine specifically designed to protect
adults. The trial evaluated the immunogenicity, tolerability and
safety of V116 compared to PCV20 (pneumococcal 20-valent conjugate
vaccine) in adults who had not previously received a pneumococcal
vaccine.
Results from the study’s primary objectives include:
- 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.
Detailed findings will be presented today at World Vaccine
Congress West Coast at 4:50 p.m. EST. The company announced topline
results of the STRIDE-3 trial earlier this year.
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. V116 includes
eight unique serotypes not covered by currently licensed
pneumococcal vaccines, which were responsible for approximately 30%
of invasive pneumococcal disease in individuals 65 years of age and
older, based on the same CDC data. If approved, V116 would be the
first pneumococcal conjugate vaccine specifically designed for
adults.
“These results provide strong evidence to support the
immunogenicity of V116 compared to the standard of care in the
prevention of invasive pneumococcal disease and pneumococcal
pneumonia in adults,” said Dr. Eliav Barr, senior vice president,
head of global clinical development and chief medical officer,
Merck Research Laboratories. “We are excited by the potential of
V116 to impact public health through primary prevention through the
use of a population-specific strategy that targets the serotypes
responsible for the majority of invasive pneumococcal disease in
adults.”
“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 Dr. Sady Alpizar, Clinical
Research Trials of Florida, Inc., 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.”
The V116 Phase 3 clinical development program is composed of
eight trials (n=8,830) investigating the safety, tolerability and
immunogenicity of V116 in various adult populations. These include
adults with and without chronic medical conditions associated with
an increased risk of pneumococcal disease, as well as individuals
who previously received a pneumococcal vaccine. An overview of the
late-stage development program is available here.
Merck is sharing data from STRIDE-3 with global regulatory
authorities.
Study Design and Additional Data from STRIDE-3
STRIDE-3 (NCT05425732) is a Phase 3, randomized, double-blind,
active comparator-controlled study evaluating the safety,
tolerability, and immunogenicity of V116 compared to PCV20 in
adults 18 years of age and older who had not previously received a
pneumococcal conjugate vaccine (n=2,663). Participants were
randomized to receive a single dose of either V116 or PCV20.
Primary endpoints across both cohorts included safety,
serotype-specific OPA GMTs 30 days post-vaccination and percentage
of participants with greater than or equal to four-fold rise from
baseline in serotype-specific OPAs. Cohort 1 enrolled participants
50 years of age and older (n=2,362) who were randomized 1:1 to
receive a single dose of either V116 or the comparator, PCV20. Key
findings from primary endpoints include:
- V116 was non-inferior to PCV20 for the 10 serotypes common to
both vaccines (3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, 33F), as
assessed by serotype-specific OPA GMTs 30 days
post-vaccination.
- V116 was superior to PCV20 for 10 of 11 serotypes included in
V116 but not in PCV20 (9N, 15A, 16F, 17, 20A, 23A, 23B, 24F, 31,
35B), as assessed by serotype-specific OPA GMTs 30 days
post-vaccination and the proportions of patients with a greater
than or equal to four-fold increase in OPA from Day 1 to Day 30.
- Immune responses were observed for serotype 15C in participants
receiving V116, but these did not meet criteria for statistical
superiority.
Cohort 2 enrolled participants 18-49 years of age (n=301) who
were randomized 2:1 to receive a single dose of either V116 or
comparator, PCV20. Results from primary endpoints showed immune
responses elicited by V116 in participants 18-49 years of age were
non-inferior (immunobridged) compared to participants 50-64 years
of age for all 21 serotypes, as assessed by serotype-specific OPA
GMTs 30 days post-vaccination.
Across both cohorts, V116 had a safety profile comparable to
PCV20. Participants administered V116 and PCV20 who reported at
least 1 adverse event (AE) were 61.7% and 67.2%, respectively.
There were no vaccine-related serious AEs or vaccine-related deaths
in the study.
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.
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 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 to address the specific
needs of different populations, including infants and children,
healthy adults and at-risk subgroups. 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 https://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” within the
meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline candidates that
the candidates will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of the global outbreak of novel coronavirus disease
(COVID-19); the impact of pharmaceutical industry regulation and
health care legislation in the United States and internationally;
global trends toward health care cost containment; technological
advances, new products and patents attained by competitors;
challenges inherent in new product development, including obtaining
regulatory approval; the company’s ability to accurately predict
future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign
risk; dependence on the effectiveness of the company’s patents and
other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s Annual
Report on Form 10-K for the year ended December 31, 2022 and the
company’s other filings with the Securities and Exchange Commission
(SEC) available at the SEC’s Internet site (www.sec.gov).
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