Kyowa Kirin Presents Additional Analyses of MAVORIC Trial

TOKYO, Dec. 3, 2018 /PRNewswire/ -- Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) announces that additional data from the MAVORIC trial (Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL) will be presented at the 60^th Annual Meeting of the American Society of Hematology (ASH), held in San Diego, California, on December 1-4.^1,2,3 Mogamulizumab is approved in the United States (U.S.) for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. MF and SS are the most common subtypes of cutaneous T-cell lymphoma (CTCL).⁴

Three Kyowa Kirin-sponsored posters featuring post-hoc analyses of the pivotal MAVORIC study will be presented during the ASH meeting. MAVORIC is the first pivotal trial to use progression free survival (PFS) as a primary endpoint and the largest randomized study to compare systemic therapies in CTCL.⁵ Secondary endpoints included proportion of patients achieving an overall response rate (ORR), duration of response (DOR) and safety.⁵

"Mycosis fungoides and Sézary syndrome may have a severe impact on patients, yet may be indolent in nature, making it challenging for both patients and physicians to control the diseases over decades," said Jeffrey S. Humphrey, M.D., President of Kyowa Kirin Development. "These additional analyses of MAVORIC provide further insight into these rare and serious diseases."

The studies being presented at ASH include:

• Abstract #3592: Evaluation of Symptom and Side Effect Bother in Cutaneous T-Cell Lymphoma Patients Treated with Mogamulizumab or Vorinostat (Hudgens S, Porcu P, Quaglino P, et al)¹
• Abstract #2910: Long-Term Clinical Benefit to Anti-CCR4 Mogamulizumab: Results from the Phase 3 MAVORIC Study in Previously Treated Cutaneous T-Cell Lymphoma (CTCL) (Bagot M, Dalle S, Sokol L, et al)²
• Abstract #1619: Efficacy of Mogamulizumab By Prior Systemic Therapy in Patients with Previously Treated Cutaneous T-Cell Lymphoma: Post Hoc Analysis from the Phase 3 MAVORIC Study (Zinzani, P, Horwitz S, Kim Y, et al)³

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

Please see Poteligeo indication and Important Safety Information below.

INDICATION
POTELIGEO^® (mogamulizumab-kpkc) 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.

About Kyowa Kirin
Kyowa Hakko Kirin Co., Ltd. is a research-based life sciences company, with special strengths in biotechnologies. In the core therapeutic areas of oncology, nephrology and immunology/allergy, Kyowa Hakko Kirin leverages leading-edge biotechnologies centered on antibody technologies, to continually discover innovative new drugs and to develop and market those drugs world-wide. In this way, the company is working to realize its vision of becoming a Japan-based global specialty pharmaceutical company that contributes to the health and wellbeing of people around the world. Kyowa Kirin International PLC is a wholly owned subsidiary of Kyowa Hakko Kirin and is a rapidly growing specialty pharmaceutical company engaged in the development and commercialization of prescription medicines for the treatment of unmet therapeutic needs in Europe and the United States. Kyowa Kirin International is headquartered in Scotland. You can learn more about the business at: www.kyowa-kirin.com.

About mogamulizumab
Mogamulizumab is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4), which is frequently expressed on leukemic cells of certain hematologic malignancies including CTCL (cutaneous T-cell lymphoma).⁶

About mycosis fungoides (MF) and Sézary Syndrome (SS)
MF and SS are the two most common subtypes of CTCL, a rare type of non-Hodgkin's lymphoma, which is characterized by localization of malignant T lymphocytes to the skin, and depending on the stage, the disease may involve skin, blood, lymph nodes, and viscera.⁵

About MAVORIC
MAVORIC is a Phase 3 open-label, multi-center, randomized study of mogamulizumab versus vorinostat in patients with MF and SS who have failed at least one prior systemic treatment.⁵ The study was conducted in the U.S., Europe, Japan and Australia, and randomized 372 patients to receive either mogamulizumab or vorinostat.⁵

Poteligeo® is a registered trademark of Kyowa Hakko Kirin, Co., Ltd.

©2018 Kyowa Hakko Kirin, Co., Ltd. All Rights Reserved.

¹ Hudgens S, Porcu P, Quaglino P, et al. Evaluation of Symptom and Side Effect Bother in Cutaneous T-Cell Lymphoma Patients Treated with Mogamulizumab or Vorinostat. Data presented at: American Society of Hematology 2018 Annual Meeting: December 1-4, 2018; San Diego, California.
² Bagot M, Dalle S, Sokol L, et al. Long-Term Clinical Benefit to Anti-CCR4 Mogamulizumab: Results from the Phase 3 Mavoric Study in Previously Treated Cutaneous T-Cell Lymphoma (CTCL). Data presented at: American Society of Hematology 2018 Annual Meeting: December 1-4, 2018; San Diego, California.
³ Zinzani P, Horwitz S, Kim Y, et al. Efficacy of Mogamulizumab By Prior Systemic Therapy in Patients with Previously Treated Cutaneous T-Cell Lymphoma: Post Hoc Analysis from the Phase 3 Mavoric Study. Data presented at: American Society of Hematology 2018 Annual Meeting: December 1-4, 2018; San Diego, California.
⁴ Leukemia & Lymphoma Society. Cutaneous T-Cell Lymphoma Facts. https://www.lls.org/sites/default/files/file_assets/cutaneoustcelllymphoma.pdf. Accessed May 2, 2018.
⁵ Kim YH, Bagot M, et al. Anti-CCR4 Monoclonal Antibody, Mogamulizumab, Demonstrates Significant Improvement in PFS Compared to Vorinostat in Patients with Previously Treated Cutaneous T-Cell Lymphoma (CTCL): Results from the Phase III MAVORIC Study. Data presented at: American Society of Hematology 2017 Annual Meeting: December 9-12, 2017; Atlanta, Georgia.
⁶ National Cancer Institute. Mogamulizumab. https://www.cancer.gov/publications/dictionaries/cancer-drug/def/mogamulizumab. Accessed May 2, 2018.

SOURCE Kyowa Hakko Kirin Co., Ltd.

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