AAD25: Amgen makes its OX40 case in atopic dermatitis

Efficacy Results

In the Phase 3 IGNITE study, rocatinlimab met its co-primary endpoints and all key secondary endpoints at 24 weeks1 6.
42.3% of patients receiving the higher 300 mg dose achieved EASI-75 (≥75% improvement in Eczema Area and Severity Index score), compared to 12.8% for placebo6 14.
23.6% of patients on the higher dose achieved vIGA-AD 0/1 (clear/almost clear skin), compared to 8.7% for placebo14.
The lower dose group also showed significant improvements over placebo, but not as strong as the higher dose14.

Safety Profile

Safety findings were generally consistent with previous studies14.
Most common adverse events were pyrexia (fever), chills, and headache14.
There was a slightly higher incidence of gastrointestinal ulceration events with rocatinlimab, but overall incidence was less than 1%14.

Mechanism of Action

Rocatinlimab is an anti-OX40 monoclonal antibody that aims to rebalance T cells by targeting the OX40 receptor6 14.
It has the potential to be the first T-cell rebalancing therapy for atopic dermatitis14.

Ongoing Development

The ROCKET Phase 3 program includes 8 studies evaluating rocatinlimab in adults and adolescents14.
Upcoming trials will assess longer-term efficacy, maintenance of response, and use in adolescents14.

While the efficacy results appear improved from earlier studies, analysts note rocatinlimab's efficacy still seems to lag behind some competing therapies like Dupixent4 8. However, Amgen sees potential for rocatinlimab as a novel mechanism of action for patients who don't respond to or lose response to current therapies4 10.