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Amgen and Kyowa Kirin Announce Phase 3 Rocatinlimab Results

In a significant advancement for treating atopic dermatitis, Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (TSE: 4151) have revealed the preliminary top-line outcomes from their ongoing ASCEND study. This research focuses on rocatinlimab, an investigational therapy that targets T-cell rebalancing via the OX40 receptor, primarily aimed at adults and adolescents suffering from moderate to severe atopic dermatitis (AD).

The study, which has enrolled about 2,600 patients, is designed to assess the long-term safety and effectiveness of rocatinlimab given at dosages of 150 mg and 300 mg, administered every four or eight weeks. Notably, this trial involved individuals who had previously completed the ROCKET trial. The ASCEND study particularly examined those who continued treatment for an additional 32 weeks, following an initial 24 weeks of therapy.

Key Findings

The primary goal of this analysis was to monitor the safety of rocatinlimab over a prolonged period. Initial findings indicated that common treatment-emergent adverse events (AEs), such as upper respiratory infections (including nasopharyngitis and pharyngitis), aphthous ulcers, headaches, influenza, cough, and rhinitis, were consistent with those recorded in previous ROCKET trials. Importantly, the rate of discontinuation due to AEs was found to be low among patients taking rocatinlimab. Additionally, during the Phase 3 ROCKET program—including ASCEND—the occurrence of gastrointestinal ulceration events with rocatinlimab was less than 1 per 100 patient-years.

The study aims to continue evaluating the long-term safety and efficacy of rocatinlimab for up to 104 weeks, thereby extending its review into the therapeutic benefits related to moderate to severe AD.

Secondary Endpoints and Patient Feedback

For secondary endpoints, the researchers evaluated adults who exhibited a clinical response (EASI 75 or vIGA-AD 0/1 without rescue treatment at week 24) during either the HORIZON or IGNITE trials. Those patients who continued rocatinlimab monotherapy with either the Q4W or Q8W dosing regimens predominantly reported sustained therapeutic outcomes at one year. Improvement was noted across various parameters, including skin clearance, itch reduction, and the severity of the disease.

Dr. Jay Bradner, Amgen's Executive Vice President of Research and Development, emphasized the uniqueness of atopic dermatitis as a complex condition, suggesting that many patients struggle to find adequate relief through current treatments. He stated, “These findings enhance our comprehension of how OX40 inhibition can tackle the disease's underlying drivers and offer insightful data about rocatinlimab's durability and long-term safety.”

Dr. Takeyoshi Yamashita, Chief Medical Officer at Kyowa Kirin, underscored that individuals with moderate to severe atopic dermatitis are in search of innovative treatment options to achieve and maintain their therapeutic goals. He remarked that the ASCEND findings mark a crucial milestone in understanding rocatinlimab and noted the potential for maintenance dosing that could occur as infrequently as every eight weeks post the initial 24-week dosage.

Ongoing Evaluations and Future Directions

As the ASCEND study remains in process, it will continue to focus on the long-term impacts of rocatinlimab for individuals dealing with moderate to severe atopic dermatitis for an inclusive period of up to two and a half years, summing up the time spent in earlier studies. The ASCEND trial is part of the larger ROCKET Phase 3 clinical program, which comprises eight studies dedicated to establishing the overall safety and efficacy profile of various rocatinlimab dosing schedules.

Context on Atopic Dermatitis

Atopic dermatitis, recognized as the most prevalent type of eczema, is a chronic inflammatory skin condition characterized by excessively dry, itchy skin, often causing significant discomfort. Individuals with moderate to severe symptoms frequently undergo painful flare-ups that disrupt their daily lives. Over 50% report suffering from severe itching, potentially leading to skin complications due to incessant scratching.

About Rocatinlimab

Rocatinlimab represents a pioneering anti-OX40 monoclonal antibody currently under investigation for treating moderate to severe atopic dermatitis. Its unique mechanism aims to correct T-cell imbalances responsible for the disease's symptoms, thereby presenting a potential first-of-its-kind T-cell rebalancing therapy. Alongside its focus on AD, rocatinlimab is also being explored for applications in other conditions like uncontrolled asthma and prurigo nodularis, where T-cell imbalance contributes to inflammation.

With this announcement, Amgen and Kyowa Kirin are set to present extensive findings at an upcoming conference or through a peer-reviewed publication, marking a significant step forward in the quest for effective atopic dermatitis treatments.