Amgen and Kyowa Kirin have announced preliminary top-line results from the ASCEND study evaluating Rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in adults and adolescents with moderate to severe Atopic Dermatitis (AD).

The ongoing ASCEND study, which includes approximately 2,600 patients, is designed to evaluate the long-term safety and efficacy of Rocatinlimab (150 mg and 300 mg) administered every four or eight weeks in individuals who completed a previous ROCKET programme trial (IGNITE, HORIZON, SHUTTLE, ASTRO, ORBIT or VOYAGER). This analysis focused on adults who completed the first 24 weeks of therapy in a previous ROCKET trial and continued in ASCEND for an additional 32 weeks.

The primary endpoint of the study was to evaluate the long-term safety of Rocatinlimab, and is descriptive in nature. The most frequent treatment-emergent Adverse Events (AEs) in adults (≥ 5 per 100 patient-years in any of the Rocatinlimab groups and greater than placebo), included upper respiratory infections (including nasopharyngitis and pharyngitis), aphthous ulcers, headache, influenza, cough and rhinitis, which were observed in previous ROCKET trials. The discontinuation rate due to AEs was low across the adult Rocatinlimab-treated cohorts.

Across the Phase-III ROCKET programme, including ASCEND, the incidence of gastro-intestinal ulceration events with Rocatinlimab to date is less than one per 100 patient-years. The ASCEND study is ongoing and continues to evaluate the long-term safety and efficacy of Rocatinlimab up to 104 weeks in adult and adolescent patients with moderate to severe AD.

The secondary endpoints of the study were evaluated in adults who achieved a clinical response (EASI 75 or vIGA-AD 0/1 without rescue use at week 24) in either the HORIZON or IGNITE trials and were re-randomised in the ASCEND study. The majority of patients in this sub-population, who continued receiving Rocatinlimab monotherapy either with Q4W or Q8W dosing, reported continued therapeutic benefit at one year of treatment across measures of improvement in skin clearance, itch, disease extent and severity.

“Atopic Dermatitis is a heterogeneous disease where many patients still lack adequate control with current therapies. These findings add to our understanding of the role OX40 inhibition can play in addressing the underlying drivers of this chronic disease and provide further information on Rocatinlimab’s durability of response and long-term safety profile, which we will continue to monitor,” said Jay Bradner, MD, Executive Vice President—Research and Development, Amgen.

The companies plan to share full results at an upcoming congress, or in a peer-reviewed publication.

“People with moderate to severe Atopic Dermatitis are looking for new options to help them achieve and sustain their treatment goals. These results mark an important milestone in furthering our understanding of Rocatinlimab. The findings from ASCEND characterise Rocatinlimab’s ongoing therapeutic benefit at one-year of treatment in adult patients with moderate to severe AD, with possible maintenance dosing as infrequently as every eight weeks, following initial 24-week dosing, an approach that may lessen the ongoing burden of treatment. We look forward to share further updates,” said Takeyoshi Yamashita, Ph.D., Chief Medical Officer, Kyowa Kirin.