Kyowa Kirin discontinues all rocatinlimab trials for atopic dermatitis, asthma, and prurigo nodularis over emerging malignancy risks, including Kaposi’s sarcoma cases. Anti-OX40 antibody showed atopic dermatitis efficacy, but safety concerns end program. Full details.
Written By: Marka Sheshi PharmD and Nikita Chaudhari BPharm
Reviewed By: Pharmacally Editorial Team
Kyowa Kirin Co. Ltd. a Japan-based global specialty pharmaceutical company announced today the discontinuation of all ongoing clinical trials for rocatinlimab, an investigational anti-OX40 monoclonal antibody. The drug was under evaluation for moderate-to-severe atopic dermatitis, moderate-to-severe uncontrolled asthma, and prurigo nodularis.
Following Amgen’s recent exit from the rocatinlimab collaboration driven by a strategic portfolio reprioritization and announced alongside Kyowa Kirin’s takeover of complete global control of the rocatinlimab program both companies jointly reviewed the latest safety data and agreed that emerging risks outweigh potential benefits for these patient populations.
Safety Update Triggers Decision
The move follows a planned safety review from the global rocatinlimab program, conducted in collaboration with partner Amgen. Both companies determined that potential risks now outweigh benefits for the studied patient populations. This reflects emerging safety data, including previously reported risks and recent concerns over malignancies with possible viral or immune-related links.
Key findings from the latest review include:
- One new confirmed case of Kaposi’s sarcoma.
- One suspected case of Kaposi’s sarcoma.
- A previously confirmed case, suggesting a mechanistic link to OX40 pathway modulation.
While overall malignancy rates remain below expected background levels, the case characteristics raise plausible biological concerns that could not be ruled out.
“This is deeply disappointing news, as we had hoped to bring a safe and effective treatment to patients,” said Abdul Mullick, Ph.D., President and Chief Operating Officer of Kyowa Kirin. “Rocatinlimab has demonstrated durable and clinically meaningful efficacy in moderate-to-severe atopic dermatitis in the ROCKET program. However, the safety profile has evolved, and as patient safety remains our highest priority, we have taken this decisive and cautious step.”
Mullick added that insights from the program will advance broader understanding of the OX40 pathway and inform future research.
Next Steps for Trials and Data Analysis
Kyowa Kirin and Amgen are notifying clinical trial investigators and regulatory authorities worldwide, including the FDA and EMA. Participants will complete required safety follow-up visits before formal trial termination. The companies plan a comprehensive analysis of the full dataset, with further updates to follow.
This development underscores ongoing challenges in immunomodulatory therapies for inflammatory diseases, where OX40 inhibition showed promise but highlighted safety hurdles.
Reference
Kyowa Kirin Announces Discontinuation of Rocatinlimab Clinical Trials, 03 March 2026, https://ir.kyowakirin.com/en/news/news-2560625228719159862/main/0/link/e20260303_01.pdf
Kyowa Kirin Takes Full Global Control of Rocatinlimab After Amgen Exit, 10 February 2026, https://pharmacally.com/kyowa-kirin-takes-full-global-control-of-rocatinlimab-after-amgen-exit/
About Writer
Marka Sheshi | Doctor of Pharmacy
Driven by a deep commitment to clinical excellence, research integrity, and impactful medical writing. With a strong foundation in pharmacotherapy and patient safety, specializes in transforming complex scientific evidence into authoritative, publication-ready content. Passionate about advancing healthcare through precise, evidence-based communication that informs practice, strengthens research visibility, and improves patient outcomes.
About Writer
Nikita Santosh Chaudhari, B.Pharm
She is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, particularly inclined towards publication writing and scientific content development. In her words, she is enthusiastic about scientific documentation and publication writing, aiming to contribute to accurate, ethical, and evidence-based medical communication.
