AMGEN AND KYOWA KIRIN ANNOUNCE TOP-LINE RESULTS FROM ROCATINLIMAB PHASE 3 ASCEND LONG-TERM EXTENSION STUDY IN ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS

THOUSAND OAKS, Calif. and TOKYO, Sept. 8, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced preliminary top-line results from the ASCEND study evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in adults and adolescents with moderate to severe atopic dermatitis (AD).

The ongoing ASCEND study, which includes approximately 2,600 patients, is designed to evaluate the long-term safety and efficacy of rocatinlimab (150 mg and 300 mg) administered every four or eight weeks in individuals who completed a previous ROCKET program trial (IGNITE, HORIZON, SHUTTLE, ASTRO, ORBIT or VOYAGER). This analysis focused on adults who completed the first 24 weeks of therapy in a previous ROCKET trial and continued in ASCEND for an additional 32 weeks.

The primary endpoint of the study was to evaluate the long-term safety of rocatinlimab and is descriptive in nature. The most frequent treatment-emergent adverse events (AEs) in adults (≥ 5 per 100 patient-years in any of the rocatinlimab groups and greater than placebo), included upper respiratory infections (including nasopharyngitis and pharyngitis), aphthous ulcers, headache, influenza, cough and rhinitis, which were observed in previous ROCKET trials. The discontinuation rate due to AEs was low across the adult rocatinlimab treated cohorts.

Across the Phase 3 ROCKET program including ASCEND, the incidence of gastrointestinal ulceration events with rocatinlimab to date is less than 1 per 100 patient-years. The ASCEND study is ongoing and continues to evaluate the long-term safety and efficacy of rocatinlimab up to 104 weeks in adult and adolescent patients with moderate to severe AD.

The secondary endpoints of the study were evaluated in adults who achieved a clinical response (EASI 75 or vIGA-AD 0/1 without rescue use at week 24) in either the HORIZON or IGNITE trials and were re-randomized in the ASCEND study. The majority of patients in this sub-population, who continued receiving rocatinlimab monotherapy either with Q4W or Q8W dosing, reported continued therapeutic benefit at one year of treatment across measures of improvement in skin clearance, itch, disease extent and severity.

"Atopic dermatitis is a heterogeneous disease where many patients still lack adequate control with current therapies," said Jay Bradner, M.D., executive vice president of Research and Development at Amgen. "These findings add to our understanding of the role OX40 inhibition can play in addressing the underlying drivers of this chronic disease and provide further information on rocatinlimab's durability of response and long-term safety profile, which we will continue to monitor."

"People with moderate to severe atopic dermatitis are looking for new options to help them achieve and sustain their treatment goals," said Takeyoshi Yamashita, Ph.D., Chief Medical Officer, Kyowa Kirin. "These results mark an important milestone in furthering our understanding of rocatinlimab. The findings from ASCEND characterize rocatinlimab's ongoing therapeutic benefit at one-year of treatment in adult patients with moderate to severe AD, with possible maintenance dosing as infrequently as every eight weeks, following initial 24-week dosing, an approach that may lessen the ongoing burden of treatment. We look forward to sharing further updates."

Amgen and Kyowa Kirin plan to share full results at an upcoming congress or in a peer-reviewed publication.

About the ASCEND Study and ROCKET Phase 3 Program

The ongoing ASCEND study will continue to evaluate the long-term safety and efficacy of rocatinlimab in adult and adolescent patients with moderate to severe AD for up to two and a half years (inclusive of time in parent studies).

ASCEND is part of the larger ROCKET Phase 3 clinical program. ROCKET is a comprehensive, global Phase 3 clinical program composed of eight studies intended to establish the safety and efficacy profile of multiple dosing regimens of rocatinlimab in adults and adolescents with moderate to severe AD as well as multiple dosing regimens.

About Moderate to Severe Atopic Dermatitis

Atopic dermatitis, the most common form of eczema¹, 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 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 effector and memory 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.^3,6

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 non-financial companies listed on the Nasdaq Stock Market based on market capitalization.

For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube and Threads.

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 leads the development, manufacturing, and commercialization for rocatinlimab 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.

Amgen Forward-Looking Statements

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CONTACT:

Amgen, Thousand Oaks

Elissa Snook, 609-251-1407 (media)

Adam Elinoff, 805-313-9775 (investors) 

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:

1. National Eczema Association. Atopic Dermatitis. Published January 27, 2025. Accessed March 6, 2025. https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/ 
2. 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. 
3. National Eczema Association. Eczema Stats. Accessed March 6, 2025. https://nationaleczema.org/research/eczema-facts/ 
4. Ständer, M.D. Atopic Dermatitis. The New England Journal of Medicine. 2021.
5. 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.
6. 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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