Amgen and Kyowa Kirin Report Positive One-Year Data on Rocatinlimab in Atopic Dermatitis

Amgen and Kyowa Kirin announced top-line results from the ASCEND trial, part of the global ROCKET Phase 3 program, evaluating rocatinlimab, an investigational OX40-targeting therapy, in adults and adolescents with moderate to severe atopic dermatitis (AD).

About the ASCEND Study

• Population: ~2,600 patients who previously completed a ROCKET trial (IGNITE, HORIZON, SHUTTLE, ASTRO, ORBIT, VOYAGER).
• Design: Evaluated rocatinlimab (150 mg, 300 mg) given every 4 or 8 weeks.
• Duration: Current analysis covers 32 weeks beyond initial 24-week ROCKET therapy, with ongoing follow-up up to 2.5 years.

Key Findings

Safety

• Primary endpoint: Long-term safety (descriptive).
• Most common adverse events (≥5/100 patient-years, >placebo):
  - Upper respiratory infections (including nasopharyngitis, pharyngitis)
  - Aphthous ulcers
  - Headache
  - Influenza
  - Cough
  - Rhinitis
• Discontinuation rate due to AEs: Low.
• GI ulceration events: <1/100 patient-years across Phase 3 program.

Efficacy

• Sub-population: Adults achieving clinical response (EASI 75 or vIGA-AD 0/1 without rescue at week 24 in IGNITE/HORIZON).
• Result: Majority maintained therapeutic benefit at 1 year with Q4W or Q8W monotherapy.
• Measures sustained: Skin clearance, itch relief, reduced disease extent and severity.

Expert Commentary

Dr. Jay Bradner, EVP, R&D, Amgen:

“These findings highlight rocatinlimab’s potential durability of response and role in addressing the underlying drivers of this chronic disease.”

Dr. Takeyoshi Yamashita, CMO, Kyowa Kirin:

“Rocatinlimab may offer sustained benefit with as little as every-eight-week dosing, potentially reducing treatment burden for patients.”

Disease Context

• Atopic Dermatitis (AD):
  - Chronic, inflammatory, intensely itchy skin condition.
  - Impacts 15–20% of children and up to 10% of adults worldwide.
  - Caused by T-cell imbalance, leading to unpredictable flare-ups, thickened skin, and infection risk.
• Unmet Need: Many moderate to severe patients lack adequate control with current therapies.

About Rocatinlimab

• Mechanism: Anti-OX40 monoclonal antibody → rebalances T cells by inhibiting/reducing pathogenic effector and memory T cells.
• Potential: First and only T-cell rebalancing therapy for AD.
• Pipeline: Also in trials for uncontrolled asthma, prurigo nodularis, and other T-cell-driven diseases.
• Partnership:
  - Discovered with La Jolla Institute for Immunology.
  - Amgen: Leads global development, manufacturing, commercialization (ex-Japan).
  - Kyowa Kirin: Retains Japan rights; may co-promote in US, EU, Asia.

Next Steps

• Full data to be presented at an upcoming medical congress or published in a peer-reviewed journal.
• ASCEND trial ongoing, evaluating outcomes up to 104 weeks.

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