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.
