Princeton, NJ, Nov. 18, 2025 (GLOBE NEWSWIRE) -- Kyowa Kirin, Inc., a wholly owned subsidiary of Kyowa Kirin Co. Ltd (TSE: 4151), today announced new clinical study data spotlighting the potential for mogamulizumab in the treatment of relapsed or refractory mycosis fungoides and Sézary syndrome, and other mature T-cell lymphomas, will be featured in three poster presentations at the American Society of Hematology (ASH) 2025 annual meeting in Orlando, FL.

The presentations will include new findings on mogamulizumab’s therapeutic benefit, safety, and pharmacodynamic profile, and insight into alternative dosing strategies, real-world treatment patterns, and relevant biomarker-associated outcomes that may serve as early indicators for treatment response.

“The breadth of data being presented at ASH reflects our progress in furthering understanding of mogamulizumab’s therapeutic potential across T-cell lymphomas,” said Daniela van Eickels, MD, PhD, MPH, Chief Medical Officer, Kyowa Kirin North America. “These analyses contribute important insights into mogamulizumab’s clinical and biological effects, knowledge that will help guide future research and treatment strategies in these difficult-to-treat blood cancers.”

ASH Presentations:

A Phase 2, multicenter, open-label, single-arm study assessing a 4-weekly dosing schedule for mogamulizumab in patients with mycosis fungoides/Sézary syndrome (MOGA-2MG-Q4W)
Poster Session I; West Halls B3-B4
Saturday, December 6, 5:30-7:30 PM ET
Poster #1875

Integrated analysis of mogamulizumab trials for mature T-cell lymphomas, investigating differences in longitudinal effects between responders and non-responders
Poster Session I; West Halls B3-B4
Saturday, December 6, 5:30-7:30 PM ET
Poster #1867

Real-world monotherapy and combination usage of mogamulizumab among patients with mycosis fungoides or Sézary syndrome in the United States
Poster Session II; West Halls B3-B4
Sunday, December 7, 6:00-8:00 PM ET
Poster #4522

U.S. POTELIGEO (mogamulizumab-kpkc) Indication

POTELIGEO injection for intravenous infusion is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

Important Safety Information

WARNINGS AND PRECAUTIONS

Dermatologic toxicity: Monitor patients for rash throughout the course of treatment. For patients who experienced dermatologic toxicity in Trial 1, the median time to onset was 15 weeks, with 25% of cases occurring after 31 weeks. Interrupt POTELIGEO for moderate or severe rash (Grades 2 or 3). Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN).

Infusion reactions: Most infusion reactions occur during or shortly after the first infusion. Infusion reactions can also occur with subsequent infusions. Monitor patients closely for signs and symptoms of infusion reactions and interrupt the infusion for any grade reaction and treat promptly. Permanently discontinue POTELIGEO for any life-threatening (Grade 4) infusion reaction.

Infections: Monitor patients for signs and symptoms of infection and treat promptly.

Autoimmune complications: Interrupt or permanently discontinue POTELIGEO as appropriate for suspected immune-mediated adverse reactions. Consider the benefit/risk of POTELIGEO in patients with a history of autoimmune disease.

Complications of allogeneic HSCT after POTELIGEO: Increased risks of transplant complications have been reported in patients who received allogeneic HSCT after POTELIGEO. Follow patients closely for early evidence of transplant-related complications.

ADVERSE REACTIONS

The most common adverse reactions (reported in ≥10% of patients) with POTELIGEO in the clinical trial were rash, including drug eruption (35%), infusion reaction (33%), fatigue (31%), diarrhea (28%), drug eruption (24%), upper respiratory tract infection (22%), musculoskeletal pain (22%), skin infection (19%), pyrexia (17%), edema (16%), nausea (16%), headache (14%), thrombocytopenia (14%), constipation (13%), anemia (12%), mucositis (12%), cough (11%), and hypertension (10%).

You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see additional Important Safety Information in full Prescribing Information as well as Patient Information.

About Kyowa Kirin

Kyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hemato-oncology, and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across the globe. 

You can learn more about Kyowa Kirin North America at: kkna.kyowakirin.com or LinkedIn: Kyowa Kirin Inc. U.S. 

Susan Thiele - Product and Therapeutic Communications, North America
Kyowa Kirin
susan.thiele.38@kyowakirin.com