Nirsevimab significantly protected infants against RSV disease in
Phase 3 trial
Nirsevimab significantly protected infants
against RSV disease in Phase 3 trial
- Nirsevimab showed a 74.5% reduction
in lower respiratory tract infections caused by RSV requiring
medical care in healthy infants1,2
- Nirsevimab is the first
investigational immunization designed to protect all infants across
the RSV season with a single dose
- Pivotal Phase 3 results published
in The New England Journal of Medicine
Paris,
March 3, 2022.
The New England Journal of Medicine (NEJM) today published detailed
results from a Phase 3 trial evaluating nirsevimab, the first
investigational long-acting antibody designed to protect all
infants across the respiratory syncytial virus (RSV) season with a
single dose. The trial involved healthy infants born at term or
late preterm (35 weeks gestational age or greater) entering their
first RSV season and met the primary endpoint, reducing the
incidence of medically attended lower respiratory tract infections
(LRTI), such as bronchiolitis or pneumonia, caused by RSV by 74.5%
(95% CI 49.6 to 87.1; P<0.001) compared to placebo.1,2A
prespecified pooled analysis of RSV-associated hospitalizations in
both the Phase 3 and Phase 2b trials was also conducted. In term
and preterm infants (greater than 28 weeks gestational age), the
proposed dose of nirsevimab demonstrated efficacy of 77.3% (95% CI
50.3 to 89.7; P<0.001) against RSV-associated
hospitalizations.1-3 In the Phase 3 MELODY trial alone, a numerical
reduction of the risk of RSV-associated hospitalizations was
observed, although not statistically significant (62.1%, 95% CI:
-8.6 to 86.8; P=0.07).1,2 In the nirsevimab arm, six of 994 infants
were hospitalized for RSV LRTI, while eight of 496 infants were
hospitalized in the placebo arm.1,2 Nirsevimab is being developed
by Sanofi and AstraZeneca.
Dr. William MullerAssociate
Professor, Pediatrics, Northwestern University Feinberg School of
Medicine and Scientific Director, Clinical and Community Trials,
Ann & Robert H. Lurie Children’s Hospital of Chicago,
Illinois“We know that RSV has seen a resurgence with the easing of
COVID-19 public health measures. This shows us a broad immunization
approach is needed to help mitigate the substantial global burden
RSV places on infants, their families and healthcare services.
These exciting data show that nirsevimab has the potential to offer
RSV protection for all infants, which would be a paradigm shift in
the approach to this disease.”
The results of the Phase 3 and Phase 2/3
clinical trials, combined with the Phase 2b trial and conducted in
different trial populations, demonstrate nirsevimab’s potential to
protect all infants across the RSV season with a single
dose.1-6
Jean-François ToussaintGlobal
Head of Research and Development Vaccines, Sanofi “With three
pivotal late-stage trials, our research has been focused on
delivering a first-in-class RSV prevention for all infants. Our
Phase 3 MELODY results in healthy late preterm and term infants
represent a major milestone toward that goal. We are pleased
nirsevimab has the potential to become the first immunization to
protect all infants across the RSV season, with only a single
dose.”
Potential to provide rapid protection
Nirsevimab is the first investigational
long-acting antibody designed to protect all infants during their
first RSV season. With nirsevimab, the goal is to provide rapid and
direct protection to the infant through a single immunization. It
is the first potential immunization to show protection against RSV
in infants in a Phase 3 trial.1,2 RSV is the most common cause of
LRTI, including bronchiolitis and pneumonia, and a leading cause of
hospitalizations in all infants.7-9
Mene PangalosExecutive Vice
President, BioPharmaceuticals R&D, AstraZeneca“Respiratory
syncytial virus is a leading cause of lower respiratory tract
infections, such as bronchiolitis or pneumonia, as well as
hospitalizations in infants. These data show for the first time,
the potential to significantly protect all infants through their
first RSV season with a single-dose immunization and we look
forward to working with health authorities to bring nirsevimab to
infants as quickly as possible.”
The safety and tolerability of nirsevimab
compared to palivizumab was evaluated in the Phase 2/3 trial, which
demonstrated nirsevimab had a similar safety and tolerability
profile compared to palivizumab when administered to infants with
congenital heart disease, chronic lung disease and prematurity (35
weeks gestational age or fewer) entering their first RSV season.5,6
Safety was assessed by monitoring the occurrence of all treatment
emergent adverse events (TEAEs) and treatment emergent serious
adverse events (TESAEs) through 360 days post-dose. The serum
levels of nirsevimab following dosing at Day 151 in this trial were
comparable with those observed in the Phase 3 trial, indicating
similar protection in this population to that in the healthy term
and late preterm infants is likely.1,2,5,6 Details from the Phase
2/3 trial were also published in NEJM. The study is ongoing, and
topline results were presented at RSVVW’21.
Regulatory submissions have begun in the first
half of 2022.
About the Phase 3 trial
MELODY is a randomized, placebo-controlled Phase
3 trial conducted across 21 countries designed to determine the
incidence of medically attended LRTI due to RSV confirmed by
reverse transcriptase polymerase chain reaction testing through 150
days after dosing, versus placebo, in healthy infants entering
their first RSV season.1,2 Healthy late preterm and term infants
(35 weeks gestational age or greater) were randomized (2:1) to
receive a single 50mg (in infants weighing <5kg) or 100mg (in
infants weighing ≥5kg) intramuscular injection of nirsevimab or
placebo. Between July 2019 and February 2021, 1,490 infants were
randomized to either nirsevimab or placebo at the RSV season
start.1,2 Pooled analyses of the RSV LRTI hospitalization endpoint
from both of the MELODY and the Phase 2b trials were prespecified
under a multiplicity-protected hierarchical testing strategy. The
overall safety profile of nirsevimab in the trial remains
consistent with previously reported results. No clinically
meaningful differences in safety results between the nirsevimab and
placebo groups were seen in MELODY and Phase 2b.1-4
The evaluation of the primary endpoint in the
MELODY trial was conducted earlier than anticipated. Global public
health measures to control COVID-19 had reduced the circulation of
all respiratory viruses, including RSV, at the time of trial
enrollment. Sufficient cases had been accrued prior to the pandemic
to evaluate nirsevimab’s ability to prevent RSV LRTI versus
placebo. An additional 1,500 infants have been enrolled in the
Northern and Southern Hemispheres to provide additional safety
information.1,2
About the Phase 2/3 trial
MEDLEY is a Phase 2/3, randomized, double-blind,
palivizumab-controlled trial with the primary objective of
assessing safety and tolerability for nirsevimab in preterm infants
and infants with congenital heart disease (CHD) and/or chronic lung
disease of prematurity (CLD) eligible to receive palivizumab.5,6
Between July 2019 and May 2021, approximately 918 infants entering
their first RSV season were dosed with either nirsevimab or
palivizumab. Safety is assessed by monitoring the occurrence of
TEAEs and TESAEs through 360 days post-dose.5,6
The evaluation of the safety and tolerability of
nirsevimab in the MEDLEY trial was carried out earlier than
anticipated. A primary analysis was conducted to allow earlier
assessment of nirsevimab’s safety and tolerability versus
palivizumab based on a sufficient number of infants being enrolled
and followed through their first RSV season.
The results of MEDLEY, MELODY, and the Phase 2b
trial demonstrate that nirsevimab provides protection against RSV
in all infants with a single dose.1-6 This all-infant population
includes preterm, healthy late preterm and term infants, as well as
infants with CLD and CHD.
These trials form the basis of regulatory
submissions that have begun in first half of 2022.
About RSV RSV is a common,
contagious virus that causes seasonal epidemics of lower
respiratory tract infections (LRTI), leading to bronchiolitis and
pneumonia in infants.10-12 It is also a leading cause of
hospitalizations in all infants.8,9 Globally, in 2015, there were
approximately 30 million cases of acute lower respiratory
infections leading to more than three million hospitalizations, and
it was estimated that there were 60,000 in-hospital deaths of
children younger than five years.12,13 In recent months, there has
been a resurgence of RSV following the easing of COVID-19 public
health measures.14,15 Most hospitalizations for RSV occur in
otherwise healthy infants born at term.16,17 Medically attended
LRTIs are associated with increased costs to the healthcare
system.18
About nirsevimab
Nirsevimab is an investigational long-acting
antibody designed to protect all infants through their first RSV
season with a single dose. Due to its extended half-life
technology, nirsevimab is being developed as a single dose for all
infants experiencing their first RSV season and infants with
specific conditions, such as congenital heart disease or chronic
lung disease, entering their first and second RSV season.2,6,19
Nirsevimab is an immunization designed to
provide direct prophylactic RSV protection to all infants via an
antibody to help prevent LRTI caused by RSV. Monoclonal antibodies
do not require the activation of the immune system to help offer
rapid and direct protection against disease.20
In March 2017, Sanofi and AstraZeneca announced
an agreement to develop and commercialize nirsevimab. Under the
terms of the agreement, AstraZeneca leads all development and
manufacturing activities and Sanofi will lead commercialization
activities and record revenues. Under the terms of the global
agreement, Sanofi made an upfront payment of €120m, has paid a
development milestone of €30m and will pay up to a further €465m
upon achievement of certain development and sales-related
milestones. The two companies share all costs and profits. Revenue
from the agreement is reported as Collaboration Revenue in the
Company’s financial statements.
Nirsevimab has been granted regulatory
designations to facilitate expedited development by several
regulatory agencies around the world. These include Breakthrough
Therapy Designation by The China Center for Drug Evaluation under
the National Medical Products Administration; Breakthrough Therapy
Designation from the US Food and Drug Administration; access
granted to the European Medicines Agency PRIority MEdicines scheme;
Promising Innovative Medicine designation by the UK Medicines and
Healthcare products Regulatory Agency; and named “a medicine for
prioritized development” under the Project for Drug Selection to
Promote New Drug Development in Pediatrics by the Japan Agency for
Medical Research and Development (AMED). Nirsevimab is currently
under clinical investigation and its safety and efficacy have not
been reviewed by any regulatory authority.
About SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
potentially life-changing treatment options and life-saving vaccine
protection to millions of people globally, while putting
sustainability and social responsibility at the center of our
ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
Media RelationsSandrine
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| nicolas.obrist@sanofi.comVictor
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| victor.rouault@sanofi.comKate
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1 508 364 4931 | kate.conway@sanofi.com
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Prevention of RSV in Healthy Late -Preterm and Term Infants. N Engl
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and Term Infants (MELODY).
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