Amgen and Kyowa Kirin Reveal Phase 3 Rocatinlimab Results for Atopic Dermatitis

Amgen and Kyowa Kirin Co., Ltd. have announced promising results from the ROCKET Phase 3 clinical trial program, which focuses on the experimental therapy rocatinlimab for the treatment of moderate to severe atopic dermatitis (AD). Rocatinlimab is designed to rebalance T-cells by targeting the OX40 receptor, a vital element in the inflammatory processes associated with AD.

One of the key studies within this program, IGNITE, explored two dosing levels of rocatinlimab to evaluate its effectiveness, safety, and tolerability. The study was conducted over 24 weeks with a randomized, double-blind, placebo-controlled framework, involving 769 adults suffering from moderate to severe AD. Participants included those previously treated with biologic agents or systemic Janus kinase (JAK) inhibitors. IGNITE successfully met its co-primary endpoints and several key secondary endpoints, indicating statistical significance for both dose levels compared to placebo.

By the end of the 24-week period, 42.3% of patients in the higher dose group achieved a 75% reduction in their Eczema Area and Severity Index score (EASI-75), which was significantly better than the placebo group by 29.5 percentage points. In the lower dose group, 36.3% of patients achieved the EASI-75 endpoint, a noteworthy difference of 23.4 percentage points versus placebo. Additionally, the study revealed that in the higher dose group, 23.6% of patients reached a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD™) score of 0 (clear) or 1 (almost clear), showcasing a 14.9% improvement compared to the placebo group. The lower dose group observed a 19.1% achievement in this endpoint, with a difference of 10.3 percentage points compared to placebo.

IGNITE also achieved success with a more stringent measure called the revised Investigator's Global Assessment (rIGA™) score. In the higher dose group, 22.7% of patients reached the rIGA score of 0/1 with a 14.4% difference from placebo, while for the lower dose group, 16.3% achieved this endpoint with an 8.0% difference from placebo.

From a safety perspective, the ROCKET program findings were consistent with previous observations of rocatinlimab's safety profile. Some common treatment-related adverse events observed in the rocatinlimab groups were fever, chills, and headaches. Gastrointestinal ulceration was noted among a few patients receiving rocatinlimab, though the overall incidence remained below 1%.

Jay Bradner, M.D., from Amgen, emphasized the challenges faced by patients with moderate to severe AD, pointing out that existing treatments often fail to maintain goals. The ROCKET results illustrate the potential for rocatinlimab to emerge as a novel therapeutic option. Takeyoshi Yamashita, Ph.D., from Kyowa Kirin, highlighted future directions, including the ASCEND trial, which will investigate the effects of rocatinlimab beyond the 24-week mark. Additionally, the ASTRO and ORBIT trials aim to assess the therapy's impact on adolescent patients.

The ROCKET program is further supported by the SHUTTLE and VOYAGER studies. The SHUTTLE study, which tested rocatinlimab in conjunction with topical corticosteroids and calcineurin inhibitors, also achieved its co-primary and secondary endpoints with significant results, demonstrating rocatinlimab's efficacy in combination therapies. The VOYAGER study confirmed rocatinlimab does not adversely affect responses to vaccinations, such as tetanus and meningococcal vaccines.

Overall, the ROCKET Phase 3 program encompasses eight studies designed to establish a comprehensive safety and efficacy profile for rocatinlimab in treating moderate to severe AD in both adults and adolescents. These developments mark a significant step forward in addressing the unmet needs of patients with AD, offering hope for improved management of this chronic and often debilitating condition.