Ongoing Studies are Evaluating Long-Term
Maintenance and Durability
THOUSAND
OAKS, Calif., and TOKYO, March 8,
2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Kyowa
Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) today announced new
results from the ongoing ROCKET Phase 3 clinical trial program
evaluating rocatinlimab, an investigational T-cell rebalancing
therapy targeting the OX40 receptor, in moderate to severe atopic
dermatitis (AD).
The IGNITE study, which evaluated two dose strengths of
rocatinlimab, met its co-primary endpoints and all key secondary
endpoints, achieving statistical significance for both rocatinlimab
dose strengths versus placebo. IGNITE was a 24-week, randomized,
placebo-controlled, double-blind study to assess the efficacy,
safety and tolerability of rocatinlimab monotherapy every 4 weeks
in 769 adults with moderate to severe AD, including patients
previously treated with a biologic or systemic Janus kinase (JAK)
inhibitor medication.
At week 24, 42.3% of patients in the higher dose group achieved
≥75% reduction from baseline in Eczema Area and Severity Index
score (EASI-75), a 29.5% difference vs. placebo (p < 0.001). In
the lower dose group, 36.3% of patients achieved EASI-75, a 23.4%
difference vs. placebo (p < 0.001).
In the higher dose group, 23.6% of patients achieved a validated
Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™)
score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction
from baseline (vIGA-AD 0/1) at week 24, representing a 14.9%
difference vs. placebo (p < 0.001). In the lower dose group,
19.1% of patients achieved this endpoint, a 10.3% difference vs.
placebo (p = 0.002).
In addition, IGNITE met the endpoint of revised Investigator's
Global Assessment (rIGA™) score of 0/1 with a ≥2-point reduction
from baseline, a more stringent measure of efficacy than vIGA-AD
0/1. At week 24, 22.7% of patients in the higher dose group
achieved this endpoint, a 14.4% difference vs. placebo (p <
0.001). In the lower dose group, 16.3% of patients achieved this
endpoint, an 8.0% difference vs. placebo (p = 0.01).
Across ROCKET program results to date, safety findings were
generally consistent with the safety profile of rocatinlimab
previously observed. The most frequent treatment-emergent adverse
events (≥5%) with higher observed proportion in rocatinlimab groups
were pyrexia, chills and headache. A higher number of patients
receiving rocatinlimab vs. placebo experienced gastrointestinal
ulceration events, with an overall incidence of less than
1%.1
"Many patients with moderate to severe atopic dermatitis
struggle with chronic, life-disrupting symptoms," said
Jay Bradner, M.D., executive vice
president of Research and Development at Amgen. "Even with
currently available therapies, they may fail to reach or maintain
treatment goals. We're pleased with ROCKET program results to date,
which support the potential of rocatinlimab as a new treatment
option."
"Looking ahead, the ASCEND trial will explore the effects of
rocatinlimab beyond 24 weeks, including maintenance of clinical
response with continued treatment or withdrawal, and the ASTRO
and ORBIT trials will evaluate rocatinlimab in adolescent
patients," said Takeyoshi Yamashita,
Ph.D., senior managing executive officer and chief medical officer
at Kyowa Kirin. "These findings will help define the full profile
of rocatinlimab and its potential to inhibit and reduce pathogenic
T cells."
The ROCKET program is also informed by the results of the
SHUTTLE and VOYAGER studies. The SHUTTLE study, which evaluated two
dose strengths of rocatinlimab in combination with topical
corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI)
in 746 adults using the same co-primary endpoints as IGNITE, met
its co-primary endpoints and all key secondary endpoints, achieving
statistical significance for both rocatinlimab dose strengths plus
TCS/TCI versus placebo plus TCS/TCI at week 24.
For EASI-75, 52.3% of patients in SHUTTLE's higher dose group
achieved the endpoint, a 28.7% difference vs. placebo (p <
0.001), while 54.1% of patients in the lower dose group achieved
the endpoint, a 30.4% difference vs. placebo (p<0.001).
For vIGA-AD 0/1, 26.1% of SHUTTLE patients in the higher dose
group achieved the endpoint, a 13.8% difference vs. placebo
(p<0.001). In the lower dose group, 25.8% of patients achieved
the endpoint, a 13.5% difference vs. placebo (p<0.001).
For rIGA 0/1, 23.3% of SHUTTLE patients in the higher dose group
achieved the endpoint, an 11.5% difference vs. placebo
(p<0.001). In the lower dose group, 22.7% of patients achieved
the endpoint, a 10.9% difference vs. placebo (p = 0.002). The
higher rocatinlimab dose used in IGNITE and SHUTTLE was identical
to the dose used in HORIZON.
The VOYAGER study successfully demonstrated that rocatinlimab
does not interfere with responses to tetanus and meningococcal
vaccinations.
HORIZON, top-line results of which were previously shared, will
be presented as a late-breaking abstract at the 2025 American
Academy of Dermatology Annual Meeting. Results from IGNITE, SHUTTLE
and VOYAGER will be presented at upcoming congresses or published
in peer-reviewed journals.
About the ROCKET Phase 3 Program
ROCKET is a
comprehensive, global Phase 3 clinical trial program comprised of
eight studies intended to establish the safety and efficacy profile
of rocatinlimab in adults and adolescents with moderate to severe
atopic dermatitis (AD) as well as multiple dosing regimens.
About Moderate to Severe Atopic Dermatitis
Atopic
dermatitis, the most common form of eczema, is a chronic
inflammatory disease that causes excessively dry, itchy skin that
can be painful.2 People with moderate to severe atopic
dermatitis experience chronic symptoms, intensified by
unpredictable flare-ups that can be painful and disruptive to
everyday life.3 More than half of these patients report
severe itching, leading to repeated scratching which can cause the
skin to thicken and become vulnerable to infection.4,5
Atopic dermatitis (all severities) affects 15-20% of children and
up to 10% of adults.5 T-cell imbalance is a root cause
of atopic dermatitis, contributing to clinical manifestations
including the disease's recurring, unpredictable
symptoms.6
About Rocatinlimab
Rocatinlimab is an anti-OX40 human
monoclonal antibody being investigated for the treatment of
moderate to severe atopic dermatitis. Rocatinlimab has the
potential to be the first and only T-cell rebalancing therapy that
inhibits and reduces pathogenic T cells by targeting the OX40
receptor. OX40 is a co-stimulatory receptor responsible for driving
systemic and local inflammatory responses in atopic dermatitis and
other conditions.3 It has been reported that effector T
cells expressing OX40 are present in the lesions of patients with
atopic dermatitis and are critical in the disease
pathophysiology.3,7
Rocatinlimab is also being studied for moderate to severe
uncontrolled asthma, prurigo nodularis and potentially other
conditions where T-cell imbalance is a root cause of inflammation.
The initial antibody was discovered in collaboration between Kyowa
Kirin and La Jolla Institute for Immunology.
Rocatinlimab is currently under clinical investigation, and its
safety and efficacy have not been evaluated by the U.S. FDA or any
other regulatory authority.
About Amgen
Amgen discovers, develops,
manufactures and delivers innovative medicines to help millions of
patients in their fight against some of the world's toughest
diseases. More than 40 years ago, Amgen helped to
establish the biotechnology industry and remains on the
cutting-edge of innovation, using technology and human genetic data
to push beyond what's known today. Amgen is advancing a
broad and deep pipeline that builds on its existing portfolio of
medicines to treat cancer, heart disease, osteoporosis,
inflammatory diseases and rare diseases.
In 2024, Amgen was named one of the "World's Most
Innovative Companies" by Fast Company and one of
"America's Best Large Employers" by Forbes, among
other external recognitions. Amgen is one of the 30
companies that comprise the Dow Jones Industrial
Average®, and it is also part of the Nasdaq-100
Index®, which includes the largest and most innovative
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Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on
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About Kyowa Kirin
Kyowa Kirin aims to discover and
deliver novel medicines and treatments with life-changing value. As
a Japan-based Global Specialty
Pharmaceutical Company, we have invested in drug discovery and
biotechnology innovation for more than 70 years and are currently
working to engineer the next generation of antibodies and cell and
gene therapies with the potential to help patients with high unmet
medical needs, such as bone & mineral, intractable
hematological diseases/hemato oncology, and rare diseases. A shared
commitment to our values, to sustainable growth, and to making
people smile unites us across the globe. You can learn more about
the business of Kyowa Kirin at: https://www.kyowakirin.com.
Amgen and Kyowa Kirin Collaboration
On June 1, 2021, Kyowa Kirin and Amgen entered into
an agreement to jointly develop and commercialize rocatinlimab.
Under the terms of the agreement, Amgen will lead the development,
manufacturing, and commercialization for KHK4083/AMG 451 for all
markets globally, except Japan,
where Kyowa Kirin will retain all rights. If approved, the
companies will co-promote the asset in the United States and Kyowa Kirin has opt-in
rights to co-promote in certain other markets including
Europe and Asia.
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CONTACT: Amgen, Thousand
Oaks
Kate Meyer, 872-867-0754 (media)
Elissa Snook, 609-251-1407
(media)
Justin Claeys, 805-313-9775
(investors)
CONTACT: Kyowa Kirin, Tokyo,
Japan
Hiroki Nakamura, +81-3-5205-7205
(Media, Global)
Subrenie Thomas-Smith 609-803-0539 (Media, US)
Ryohei Kawai, +81-3-5205-7206
(Investors)
References
- ROCKET results to date are from IGNITE, HORIZON, SHUTTLE
and VOYAGER trials.
- National Eczema Association. Atopic Dermatitis. Published
January 27, 2025. Accessed
March 6, 2025.
https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/
- Croft M, Esfandiari E, Chong C, et al. OX40 in the pathogenesis
of atopic dermatitis—a new therapeutic target. Am J Clin
Dermatol. 2024;25(3):447-461. doi:10.1007/s40257-023-00838-9.
Epub 2024 Jan 18. Erratum in: Am J Clin Dermatol.
2024;25(3):463. doi:10.1007/s40257-024-00850-7. PMID: 38236520;
PMCID: PMC11070399.
- National Eczema Association. Eczema Stats. Accessed
March 6,
2025. https://nationaleczema.org/research/eczema-facts/
- Ständer, M.D. Atopic Dermatitis. The New England Journal of
Medicine. 2021.
- Agrawal R, Wisniewski JA, Woodfolk JA. The role of regulatory T
cells in atopic dermatitis. Curr Probl Dermatol. 2011;41:112-124.
doi: 10.1159/000323305. Epub 2011 May 12. PMID: 21576952; PMCID:
PMC4547455.
- Furue M, Furue M. OX40L-OX40 Signaling in Atopic Dermatitis. J
Clin Med. 2021 Jun 11;10(12):2578. doi: 10.3390/jcm10122578. PMID:
34208041; PMCID: PMC8230615.
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