PNEU-WAY (V114-018) and PNEU-FLU (V114-021)
Part of Broad Phase 3 Clinical Program
Filing Planning Underway with Regulatory
Authorities
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced results from two initial Phase 3 studies
evaluating the safety, tolerability and immunogenicity of V114, the
company’s investigational 15-valent pneumococcal conjugate vaccine.
Results from the PNEU-WAY (V114-018) study in adults 18 years of
age or older living with Human Immunodeficiency Virus (HIV) showed
that V114 elicited an immune response to all 15 serotypes included
in the vaccine, including serotypes 22F and 33F. Results from the
PNEU-FLU (V114-021) study in healthy adults 50 years of age or
older showed that V114 can be given concomitantly with the
quadrivalent influenza vaccine. These data, in addition to results
from V110-029, a study evaluating PNEUMOVAX ® 23 (Pneumococcal
Vaccine Polyvalent) in healthy adults 50 years of age or older,
were published via the International Symposium on Pneumococci and
Pneumococcal Diseases (ISPPD) online digital library.
“Certain populations are at greater risk for pneumococcal
disease, reinforcing the importance of investigating new
interventions focused on their specific needs,” said Dr. Luwy
Musey, executive director in biologics, vaccine clinical research,
Merck Research Laboratories. “Results from these first two Phase 3
studies of V114 are encouraging and we look forward to sharing
additional data in the future from our ongoing clinical development
program, including our pivotal studies assessing the immunogenicity
of V114 and its potential to protect against the serotypes most
likely to cause invasive disease.”
The V114 Phase 3 clinical development program is comprised of 16
trials investigating the safety, tolerability and immunogenicity of
V114 in a variety of populations who are at increased risk for
pneumococcal disease including both healthy older adult and healthy
pediatric populations, as well as people who are immunocompromised
or have certain chronic conditions. An overview of the late-stage
development program is available here. The company plans to
continue to work with the U.S. Food and Drug Administration (FDA)
and other regulatory authorities around the world on filing plans
for licensure of this vaccine as additional data from the Phase 3
program become available.
About PNEU-WAY PNEU-WAY was a Phase 3, multicenter,
randomized, double-blind, active comparator-controlled study to
evaluate the safety, tolerability and immunogenicity of V114
followed by administration of PNEUMOVAX 23 eight weeks later in
adults 18 years of age or older living with HIV. A total of 302
participants were randomized 1:1 to receive V114 (N=152) or the
currently available 13-valent pneumococcal conjugate vaccine
(PCV13) (N=150) followed by PNEUMOVAX 23.
V114 met its primary immunogenicity objective as measured by
serotype-specific opsonophagocytic activity (OPA) Geometric Mean
Titers (GMTs) and Immunoglobulin G (IgG) Geometric Mean
Concentrations (GMCs) for all 15 serotypes contained in the vaccine
at 30 days post-vaccination. In an exploratory comparative
analysis, the OPA GMTs and IgG GMCs for the 13 shared serotypes
between V114 and PCV13 were generally comparable between the two
groups. Additionally, immune responses were higher in the V114
group compared with the PCV13 group for the two serotypes unique to
V114 (22F and 33F). The safety profile of V114 was generally
comparable with PCV13.
About PNEU-FLU PNEU-FLU was a Phase 3, multicenter,
randomized, double-blind, placebo-controlled study to evaluate the
safety, tolerability and immunogenicity of V114 when administered
concomitantly or non-concomitantly with the influenza vaccine in
healthy adults 50 years of age or older (N=1,200). Participants
randomized to the concomitant group received V114 and the
quadrivalent influenza vaccine (QIV) on Day 1 and received placebo
approximately 30 days later at Visit 2. Participants randomized to
the non-concomitant group received placebo and QIV on Day 1 and
received V114 approximately 30 days later at Visit 2.
The study met both of its primary immunogenicity objectives.
V114 administered concomitantly with QIV was noninferior compared
to V114 administered non-concomitantly with QIV, based on the
serotype-specific OPA GMTs at 30 days post-vaccination with V114.
Additionally, QIV administered concomitantly with V114 was
noninferior to QIV administered non-concomitantly with V114, based
on the influenza strain-specific hemagglutination inhibition (HAI)
GMTs at 30 days post-vaccination with QIV. The safety profiles were
generally comparable between the two vaccination groups based on
the cumulative safety data.
About V114 V114 is Merck’s investigational 15-valent
pneumococcal conjugate vaccine in Phase 3 development for the
prevention of pneumococcal disease in adults and children. V114
consists of pneumococcal polysaccharides from 15 serotypes
conjugated to a CRM197 carrier protein and includes serotypes 22F
and 33F, which are commonly associated with invasive pneumococcal
disease worldwide and are not contained in the pneumococcal
conjugate vaccine currently licensed for use in adults.
About Pneumococcal Disease The global prevalence of
pneumococcal disease, an infection caused by bacteria called
Streptococcus pneumoniae, is evolving. Highly aggressive strains,
or serotypes, threaten to put more people at risk for non-invasive
pneumococcal illnesses such as pneumonia (when it is confined to
the lungs), sinusitis, and otitis media (middle ear infection); and
invasive pneumococcal illnesses such as bacteremia (infection in
the bloodstream), bacteremic pneumonia (pneumonia with bacteremia)
and meningitis. While healthy adults and children can suffer from
pneumococcal disease, patient populations particularly vulnerable
to infection include children under the age of 2, older adults such
as those 65 years of age and older, and people with
immunosuppressive or certain chronic health conditions.
Indication for PNEUMOVAX 23 (Pneumococcal Vaccine
Polyvalent) PNEUMOVAX 23 is a vaccine indicated for active
immunization for the prevention of pneumococcal disease caused by
the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F,
8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F
and 33F).
PNEUMOVAX 23 is approved for use in persons 50 years of age or
older and persons aged ≥2 years who are at increased risk for
pneumococcal disease.
PNEUMOVAX 23 will not prevent disease caused by capsular types
of pneumococcus other than those contained in the vaccine.
Select Safety Information for PNEUMOVAX 23 Do not
administer PNEUMOVAX 23 to individuals with a history of a
hypersensitivity reaction to any component of the vaccine.
Defer vaccination with PNEUMOVAX 23 in persons with moderate or
severe acute illness.
Use caution and appropriate care in administering PNEUMOVAX 23
to individuals with severely compromised cardiovascular and/or
pulmonary function in whom a systemic reaction would pose a
significant risk.
Available human data from clinical trials of PNEUMOVAX 23 in
pregnancy have not established the presence or absence of a
vaccine-associated risk.
Since elderly individuals may not tolerate medical interventions
as well as younger individuals, a higher frequency and/or a greater
severity of reactions in some older individuals cannot be ruled
out.
Persons who are immunocompromised, including persons receiving
immunosuppressive therapy, may have a diminished immune response to
PNEUMOVAX 23.
PNEUMOVAX 23 may not be effective in preventing pneumococcal
meningitis in patients who have chronic cerebrospinal fluid (CSF)
leakage resulting from congenital lesions, skull fractures or
neurosurgical procedures.
The most common adverse reactions, reported in >10% of
subjects vaccinated with PNEUMOVAX 23 in clinical trials, were:
injection-site pain/soreness/tenderness, injection-site
swelling/induration, headache, injection-site erythema, asthenia
and fatigue, and myalgia.
For subjects aged 65 years or older in a clinical study,
systemic adverse reactions which were determined by the
investigator to be vaccine-related were higher following
revaccination than following initial vaccination.
Vaccination with PNEUMOVAX 23 may not offer 100% protection from
pneumococcal infection.
Merck’s Commitment to Infectious Diseases For more than
100 years, Merck has contributed to the discovery and development
of novel medicines and vaccines to combat infectious diseases. In
addition to a combined portfolio of vaccines and antibacterial,
antiviral and antifungal medicines, Merck has multiple programs
that span discovery through late-stage development. To learn more
about Merck’s infectious diseases pipeline, visit
www.merck.com.
About Merck For more than 125 years, Merck, known as MSD
outside of the United States and Canada, has been inventing for
life, bringing forward medicines and vaccines for many of the
world’s most challenging diseases in pursuit of our mission to save
and improve lives. We demonstrate our commitment to patients and
population health by increasing access to health care through
far-reaching policies, programs and partnerships. Today, Merck
continues to be at the forefront of research to prevent and treat
diseases that threaten people and animals – including cancer,
infectious diseases such as HIV and Ebola, and emerging animal
diseases – as we aspire to be the premier research-intensive
biopharmaceutical company in the world. For more information, visit
www.merck.com and connect with us on Twitter, Facebook, Instagram,
YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA This news release of Merck & Co.,
Inc., Kenilworth, 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 products that the products 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 recent 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 2019
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
Before administering PNEUMOVAX® 23, please read the
accompanying Prescribing Information. The Patient Information also
is available.
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