Core Insights - Amgen and Kyowa Kirin announced preliminary top-line results from the ASCEND study, which evaluates rocatinlimab, a T-cell rebalancing therapy targeting the OX40 receptor, for treating moderate to severe atopic dermatitis [1][2] Study Overview - The ASCEND study involves approximately 2,600 patients and assesses the long-term safety and efficacy of rocatinlimab administered at doses of 150 mg and 300 mg every four or eight weeks [2] - The primary endpoint focuses on the long-term safety of rocatinlimab, with a descriptive nature [3] - The study is part of the larger ROCKET Phase 3 clinical program, which includes eight studies aimed at establishing the safety and efficacy profile of rocatinlimab [8][7] Safety and Efficacy Findings - The most common treatment-emergent adverse events in adults included upper respiratory infections, aphthous ulcers, headache, influenza, cough, and rhinitis, with a low discontinuation rate due to adverse events [3][4] - The incidence of gastrointestinal ulceration events with rocatinlimab is less than 1 per 100 patient-years [4] - Secondary endpoints showed that patients who achieved a clinical response in previous trials reported continued therapeutic benefits after one year of treatment [5] Expert Commentary - Amgen's executive vice president highlighted the importance of understanding OX40 inhibition in addressing atopic dermatitis and emphasized the durability of rocatinlimab's response and long-term safety profile [6] - Kyowa Kirin's Chief Medical Officer noted that the results represent a significant milestone in understanding rocatinlimab's ongoing therapeutic benefits, with potential maintenance dosing every eight weeks [6] Future Plans - Amgen and Kyowa Kirin plan to present full results at an upcoming congress or in a peer-reviewed publication [6]