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THOUSAND OAKS/TOKYO - Amgen (NASDAQ:AMGN) and Kyowa Kirin (TSE:4151) announced preliminary results from their ASCEND study evaluating rocatinlimab in moderate to severe atopic dermatitis patients, showing continued therapeutic benefit after one year of treatment. According to InvestingPro data, Kyowa Kirin, with a market capitalization of $12.3 billion and revenue growth of 5.26% in the last twelve months, is currently trading near its 52-week high of $15.67.
The ongoing study, which includes approximately 2,600 patients, evaluated rocatinlimab (150 mg and 300 mg) administered every four or eight weeks in adults who completed 24 weeks of therapy in a previous ROCKET program trial and continued in ASCEND for an additional 32 weeks.
According to the companies, the primary endpoint focused on long-term safety. The most frequent treatment-emergent adverse events included upper respiratory infections, aphthous ulcers, headache, influenza, cough, and rhinitis. The discontinuation rate due to adverse events was reported as low across the adult treatment groups. InvestingPro analysis shows Kyowa Kirin maintains a "GOOD" Financial Health score of 2.54, suggesting strong operational stability.
The incidence of gastrointestinal ulceration events with rocatinlimab across the Phase 3 ROCKET program, including ASCEND, was less than 1 per 100 patient-years, the companies stated.
For secondary endpoints, the majority of patients who continued receiving rocatinlimab monotherapy maintained therapeutic benefit at one year of treatment across measures of skin clearance, itch, disease extent and severity.
"These findings add to our understanding of the role OX40 inhibition can play in addressing the underlying drivers of this chronic disease," said Jay Bradner, executive vice president of Research and Development at Amgen, in a statement based on the press release.
The ASCEND study will continue to evaluate rocatinlimab’s long-term safety and efficacy for up to two and a half years. Rocatinlimab is an investigational anti-OX40 monoclonal antibody that targets T-cell imbalance, which is considered a root cause of atopic dermatitis. For investors interested in deeper analysis of pharmaceutical companies like Kyowa Kirin, InvestingPro offers exclusive insights, including 12 additional ProTips and comprehensive financial metrics that can help evaluate investment potential in the biotech sector.
The companies plan to share full results at an upcoming medical congress or in a peer-reviewed publication. Rocatinlimab has not been approved by any regulatory authority.
In other recent news, Kura Oncology, Inc. and Kyowa Kirin Co., Ltd. announced promising results from their KOMET-007 trial. The trial tested the combination of ziftomenib with standard chemotherapy for newly diagnosed acute myeloid leukemia (AML) patients. The clinical data indicated high response rates, with 92% of the 71 response-evaluable patients achieving composite complete remission. Specifically, the treatment was 93% effective in patients with NPM1 mutations and 89% effective in those with KMT2A rearrangements. These findings were presented at the European Hematology Association 2025 Congress in Milan. The results are considered a significant development in the treatment of AML, offering potential new options for patients with specific genetic mutations.
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