Kyowa Kirin has announced the global discontinuation of all ongoing clinical trials for rocatinlimab, an anti-OX40 monoclonal antibody under investigation for moderate-to-severe atopic dermatitis (AD), prurigo nodularis, and moderate-to-severe asthma.
The decision to suspend the rocatinlimab clinical trial programme follows a planned safety review.
The recent safety update from the global clinical programme led Kyowa Kirin and Amgen to conclude that potential risks may outweigh the benefits for the patient populations studied.
This assessment considered emerging safety information, which included previously reported risks.
Over the past several weeks, a safety review raised concerns about malignancies possibly linked to viral or immune-related mechanisms. The review identified one new confirmed case and one suspected case of Kaposi’s sarcoma, besides a previously confirmed case.
These findings suggest a potential mechanistic connection to OX40 pathway modulation. Although the overall number of malignancies is still lower than anticipated background levels, the attributes of these cases present a plausible biological concern that cannot be disregarded.
Kyowa Kirin's president and chief operating officer Abdul Mullick said: “This is deeply disappointing news, as we had hoped to bring a safe and effective treatment to patients. Rocatinlimab has demonstrated durable and clinically meaningful efficacy in moderate-to-severe atopic dermatitis in the ROCKET programme.
“However, the safety profile has evolved, and as patient safety remains our highest priority, we have taken this decisive and cautious step.”
Both Kyowa Kirin and Amgen are notifying regulatory authorities and trial investigators about the decision.
All studies will be formally terminated after participants complete the required safety follow-up visits. The companies will jointly analyse the full dataset and plan to provide further updates after data assessments are completed.
In September 2025, Amgen and Kyowa Kirin announced initial top line findings from the Phase III ASCEND trial of rocatinlimab for treating adults and adolescents with moderate to severe AD.
