Key Insights:
- Phase 3 ASCEND trial shows promising long-term safety and sustained clinical benefit of rocatinlimab in moderate to severe atopic dermatitis.
- Majority of patients maintained improvement at one year with dosing flexibility up to every 8 weeks.
- Findings strengthen the case for OX40 inhibition as a next-generation therapeutic strategy in chronic inflammatory skin disease.
Breakthrough Data From ASCEND Long-Term Extension
Amgen and Kyowa Kirin released top-line results from the global Phase 3 ASCEND study, involving approximately 2,600 patients with moderate to severe atopic dermatitis. Rocatinlimab, an investigational anti-OX40 monoclonal antibody, demonstrated a favorable long-term safety profile with low discontinuation rates and treatment-emergent adverse events consistent with earlier studies. The trial is designed to evaluate safety and efficacy up to 104 weeks, underscoring its potential as a durable treatment option.
Durable Clinical Response Beyond Initial Therapy
Patients who previously responded to rocatinlimab in earlier ROCKET trials and continued in ASCEND reported sustained therapeutic benefits at one year. Clinical outcomes—including skin clearance, reduced itch, and disease severity improvements—were maintained with both every-four-week and every-eight-week dosing schedules. This suggests the potential for a less burdensome treatment pathway for patients managing chronic disease.
Strengthening the OX40 Inhibition Rationale
By targeting the OX40 receptor, rocatinlimab addresses T-cell imbalance, a core driver of atopic dermatitis. The ASCEND findings provide further evidence that OX40 inhibition can deliver long-term disease control, with a safety profile suitable for chronic use. As gastrointestinal ulceration events remained rare (<1 per 100 patient-years), confidence in its long-term viability is reinforced.
A Global Partnership to Expand Access
The Amgen–Kyowa Kirin collaboration leverages Amgen’s global commercialization leadership while retaining Kyowa Kirin’s rights in Japan. Together, the companies aim to advance rocatinlimab toward regulatory review and potential market introduction. If approved, rocatinlimab could emerge as the first T-cell rebalancing therapy for atopic dermatitis, offering a novel mechanism and dosing flexibility to address unmet needs across diverse patient populations.
About Amgen
Amgen (NASDAQ: AMGN), headquartered in Thousand Oaks, California, is a pioneer in biotechnology with more than 40 years of innovation. The company develops and delivers transformative medicines across oncology, cardiology, immunology, bone health, and rare diseases, supported by a pipeline leveraging genetics, AI, and advanced biologics. Amgen is part of the Dow Jones Industrial Average® and Nasdaq-100 Index®, with a mission to improve lives through science and innovation.
About Kyowa Kirin
Kyowa Kirin Co., Ltd. (TSE: 4151), based in Tokyo, is a global specialty pharmaceutical company dedicated to creating novel medicines in areas of high unmet need. With expertise in antibody engineering and next-generation therapeutics, Kyowa Kirin focuses on bone and mineral diseases, oncology, nephrology, immunology, and rare conditions. For over 70 years, the company has advanced biotechnology innovation, aiming to deliver life-changing value to patients worldwide.
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