Kyowa Kirin Discontinues Rocatinlimab Clinical Trials

Kyowa Kirin announced the discontinuation of all ongoing clinical trials for rocatinlimab, an investigational anti-OX40 monoclonal antibody being evaluated for potential indications in moderate-to-severe atopic dermatitis, prurigo nodularis, and moderate-to-severe asthma. This decision was informed by a recent planned safety update from the global rocatinlimab clinical program. Based on this update, Kyowa Kirin and Amgen have concluded that the potential risks may outweigh the benefits for the studied patient populations. This determination reflects the totality of emerging safety information, including previously reported safety risks. The most recent safety review conducted over the last several weeks identified emerging concerns of malignancies with possible viral or immune-related links. This included one new confirmed case and one suspected case of Kaposi's sarcoma, in addition to the previously confirmed case, suggesting a potential mechanistic link to OX40 pathway modulation. While the overall number of malignancy cases across the program remains below expected background rates, the characteristics of these cases raise a plausible biological concern that cannot be excluded. Both companies are currently notifying clinical trial investigators and regulatory authorities. After trial participants complete required safety follow-up visits, all studies will be formally terminated. The companies will work together to conduct a comprehensive analysis of the full dataset and are committed to providing further updates once data assessments are complete.