In the Phase 2b/3 trial, clesrovimab reduced
RSV-associated hospitalizations (secondary endpoint) and
RSV-associated lower respiratory infection hospitalizations
(tertiary endpoint) by more than 84% and 90%, respectively, through
5 months
Clesrovimab has the potential to become the
first and only approved immunization designed to protect infants
with the same single dose regardless of weight for the duration of
their first RSV season
Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, today announced the presentation of positive results from
the Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab,
the company’s investigational prophylactic monoclonal antibody
designed to protect infants from respiratory syncytial virus (RSV)
disease during their first RSV season. The results, along with
interim findings from the ongoing Phase 3 trial (MK-1654-007) of
clesrovimab, were presented during IDWeek 2024, held October 16-19
in Los Angeles, California.
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Figure 1 (Graphic: Business Wire)
Results from MK-1654-004, a placebo-controlled Phase 2b/3
pivotal trial evaluating a single dose of clesrovimab administered
to healthy preterm and full-term infants (birth to 1 year of age)
met all prespecified endpoints, with consistent results through
both the 5-month and 6-month time points. The incidence of adverse
events (AEs) and serious AEs were comparable between the
clesrovimab and placebo groups, and there were no treatment or
RSV-related deaths during the study.
“RSV continues to be a widespread seasonal infection that can
affect both healthy and at-risk infants and is the leading cause of
hospitalization for infants,” said Dr. Octavio Ramilo, chair of the
Department of Infectious Diseases at St. Jude’s Children’s Research
Hospital and investigator for the MK-1654-004 and MK-1654-007
trials. “The MK-1654-004 study evaluated a broad spectrum of RSV
disease ranging from mild outpatient illness to severe disease
requiring hospitalization. These promising results demonstrating
decreased incidence of RSV disease, including hospitalizations,
highlight the potential for clesrovimab to play an important role
in helping to alleviate the continued burden of RSV on infants and
their families.”
The primary efficacy endpoint of the trial, the reduction in
incidence of RSV-associated medically attended lower respiratory
infections (MALRI) requiring ≥ 1 indicator of lower respiratory
infection (LRI) or severity compared to placebo through Day 150 (5
months) postdose, was 60.4% (95% CI: 44.1, 71.9, p<0.001).
Clesrovimab also reduced RSV-associated hospitalizations (secondary
endpoint) and RSV-associated LRI hospitalizations (tertiary
endpoint) through Day 150 (5 months) compared to placebo by 84.2%
(95% CI: 66.6, 92.6, p<0.001) and 90.9% (95% CI: 76.2, 96.5),
respectively. Clesrovimab reduced the incidence of severe MALRI
(tertiary endpoint) by 91.7% (95% CI: 62.9, 98.1).
In addition, in a post hoc analysis, the reduction in incidence
of MALRI requiring ≥ 2 indicators of LRI and severity (an endpoint
of more severe MALRI than the primary MALRI endpoint), was 88.0%
(95% CI: 76.1, 94.0) through Day 150 (5 months).
Additional details on the data from the MK-1654-004 trial across
RSV disease burden are presented in order of decreasing disease
severity endpoints in Figure 1 above.
Merck also announced data from a planned interim analysis of the
MK-1654-007 trial, a Phase 3 trial evaluating the safety and
efficacy of clesrovimab versus palivizumab in infants and children
at increased risk for severe RSV disease. The primary endpoint of
the study is the safety and tolerability of clesrovimab in infants
entering their first RSV season. Interim results showed clesrovimab
had a comparable safety profile to palivizumab, and no drug-related
serious AEs were reported to date. Incidence rates of
RSV-associated MALRI requiring ≥ 1 indicator of LRI or severity and
RSV-associated hospitalizations (secondary endpoints) were also
comparable between clesrovimab (3.6% and 1.3%, respectively) and
palivizumab (3.0% and 1.5%, respectively) through Day 150 (5
months).
“The breadth of data presented at IDWeek highlight the potential
for clesrovimab to help lessen the significant impact RSV can have
on infants and their families, as well as the strain on healthcare
systems due to high infection and hospitalization rates,” said Dr.
Paula Annunziato, senior vice president, infectious diseases and
vaccines, Global Clinical Development, Merck Research Laboratories.
“These clinically meaningful findings also reinforce the potential
for clesrovimab to be the first and only immunization designed to
protect both healthy and at-risk infants using the same dose,
regardless of weight. We look forward to continuing to discuss
these data with health authorities around the world with the goal
of making clesrovimab available for infants as early as the 2025-26
RSV season.”
About MK-1654-004 MK-1654-004 (NCT04767373) is a Phase
2b/3 double-blind, randomized, placebo-controlled clinical trial to
evaluate the safety and efficacy of clesrovimab in healthy preterm
and full-term infants from birth to 1 year of age entering their
first RSV season. The study enrolled 3,632 participants who were
randomized 2:1 to receive either a single fixed dose of clesrovimab
(105 mg intramuscular injection (IM)) or placebo on Day 1. Primary
endpoints included the incidence of participants with
RSV-associated medically attended lower respiratory infection
(MALRI) from Day 1 (postdose) to Day 150 as compared to placebo and
safety. The MALRI definition required >1 indicator of LRI or severity. RSV-associated
hospitalization through Day 150 and MALRI requiring >1 indicator of LRI or severity to Day 180,
were prespecified secondary endpoints. Prespecified tertiary
endpoints included acute respiratory infection, RSV-associated
lower respiratory infection hospitalizations and incidence of
severe MALRI through Day 150. In a post hoc analysis, more severe
forms of RSV-associated MALRI (>2
indicators of LRI and severity) were assessed. Across endpoints,
additional measures of efficacy were assessed through Day 180.
Safety measures included the percentage of participants with
solicited injection-related adverse events (AEs), AEs of special
interest (AESIs) solicited systemic AEs or serious adverse events
(SAEs).
About MK-1654-007 MK-1654-007 (NCT04938830) is a Phase 3,
multicenter, randomized, partially blinded, controlled study to
evaluate the safety, efficacy, and pharmacokinetics of clesrovimab
in infants and children at increased risk for severe RSV disease
compared to palivizumab. The study enrolled participants who were
entering their first RSV season and recommended to receive
palivizumab due to prematurity (≤35 weeks gestational age), chronic
lung disease (CLD) of prematurity, or hemodynamically significant
congenital heart disease (CHD). Participants were randomized 1:1 to
receive clesrovimab (105 mg IM on Day 1, placebo on Day 28) or
monthly palivizumab in their first season, and eligible
participants received clesrovimab (210 mg IM) in the second RSV
season. At this interim analysis, 901 participants were enrolled in
the trial. The primary endpoint is safety and tolerability of
clesrovimab versus palivizumab in the first season. Secondary
endpoints include the incidence of RSV-associated medically
attended lower respiratory infections (MALRI) requiring ≥1
indicator of LRI or severity and of RSV-associated hospitalization
through Day 150.
About clesrovimab (MK-1654) Clesrovimab (MK-1654) is an
investigational, extended half-life monoclonal antibody (mAb)
developed as a passive immunization for the prevention of RSV.
Clesrovimab is designed to be administered as the same single dose,
regardless of birth weight, and is being studied in healthy
preterm, full-term and at-risk infants to provide direct, rapid,
and durable protection through their first RSV season against mild,
moderate and severe RSV.
About RSV Respiratory syncytial virus (RSV) is a
contagious virus that causes widespread seasonal infections like
the flu, with a worldwide burden in infants and older adults. There
is high unmet need for preventative options in both healthy and
high-risk infants. Globally, RSV is the leading cause of
hospitalization for healthy infants under a year old. RSV can lead
to serious respiratory conditions like bronchiolitis and pneumonia,
causing an estimated 101,000 deaths a year worldwide in children
under five. According to the CDC, RSV season starts in the fall and
peaks in the winter in most regions of the United States, but
timing and severity in a given community or region can vary year to
year.
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.
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