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, evaluated the long-term safety and efficacy of rocatinlimab when administered every four or eight weeks in individuals who completed a previous ROCKET programme trial.
The primary endpoint of the study was to evaluate the long-term safety of rocatinlimab, and the discontinuation rate due to adverse effects was low across the adult rocatinlimab treated cohorts.
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 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,” said Jay Bradner, executive vice president of Research and Development at Amgen. “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.”
Takeyoshi Yamashita, Chief Medical Officer, Kyowa Kirin, said: “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 sharing further updates.”