Jun 3, 2019   SOURCE: PR NewsWire

Kyowa Kirin Presents Post-Hoc Analysis of Pivotal Trial for Poteligeo® (mogamulizumab-kpkc)

TOKYO, June 3, 2019 /PRNewswire/ -- Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) announces that a post-hoc analysis of the MAVORIC trial (Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL) is being presented today at the 2019 Annual Meeting of the American Society of Clinical Oncology (ASCO).

MAVORIC is the first pivotal trial in cutaneous T-cell lymphoma (CTCL) to use progression free survival (PFS) as a primary endpoint.(1 )In the Phase 3 trial, 372 adult patients with previously treated mycosis fungoides (MF) or Sézary syndrome (SS) stages IB to IV were randomized to either mogamulizumab (1 mg/kg dosed once weekly for the first 5 infusions, then once every 2 weeks) or vorinostat, dosed per prescribing information.(1 )Patients were treated until disease progression in any compartment (skin, blood, lymph, or viscera) or unacceptable toxicity. Mean PFS was 7.6 vs 3.1 months with mogamulizumab vs vorinostat, respectively, P<0.001.(1)

The study being presented at ASCO examined time to next treatment in patients with MF and SS to further explore the patient clinical experience. For this analysis, time to next treatment was defined as time to any therapy excluding topical steroids or focal radiation. In MF and SS, time to next treatment represents an additional measure of clinical benefit and disease control in patients who may have progressed based on strict protocol definitions of progression.(2)

The median time to next treatment for the full population of MAVORIC was longer with mogamulizumab at 11 months (95% CI, 8.8-12.6) compared to vorinostat at 3.5 months.(2) Median time to next treatment was also longer for patients treated with mogamulizumab versus vorinostat across disease stage grouping (IB/II: mogamulizumab, n=68, 7.0 months [4.9-10.1] vs. vorinostat n=72, 3.3 months [2.8-4.9]; III/IV: mogamulizumab, n=118, 12.9 months [10.6-16.7] vs. vorinostat n=114, 3.5 months [2.8-4.7]) or by disease type (MF: mogamulizumab, n=105, 8.8 months [6.1-11.55] vs. vorinostat, n=99, 4.1 months [3.1-5.2]; SS: mogamulizumab, n=81, 12.9 months [10.7-16.7] vs. vorinostat, n=87, 3.3 months [2.6-3.8]).(2)

"Cutaneous T-cell lymphomas like mycosis fungoides and Sézary syndrome are chronic skin malignancies characterized by relapsing and remitting behavior and progressive resistance to treatments. They are slow to progress and may require many lines of systemic therapy over the disease course," said Jeffrey S. Humphrey, M.D., President and Chief Medical Officer of Kyowa Kirin Pharmaceutical Development, Inc. "The data from this analysis further underscores the potential benefit of Poteligeo for patients living with these rare and serious diseases who have had at least one systemic therapy."

Poteligeo is approved in the United States for the treatment of adult patients with relapsed or refractory MF or SS after at least one prior systemic therapy. MF and SS are the most common subtypes of CTCL.(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%).

The full prescribing information can be found here: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761051s000lbl.pdf.

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).(4)

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.(3)

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.(1) The study was conducted in the U.S., Europe, Japan and Australia, and randomized 372 patients to receive either mogamulizumab or vorinostat.(1 )

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

©2019 Kyowa Hakko Kirin, Co., Ltd. All Rights Reserved.

(1) Kim Y, Bagot M, Pinter-Brown, L et al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncology. 2018. 1192-1204.
(2) Pro B, Kim Y, Ortiz-Romero P, et al. Time to Next Treatment in Patients with Previously Treated Cutaneous T-Cell Lymphoma (CTCL) Receiving Mogamulizumab or Vorinostat: A MAVORIC Post-Hoc Analysis. Data presented at: American Society of Clinical Oncology 2019 Annual Meeting: May 31-June 4, 2019; Chicago, Illinois.
(3) Leukemia & Lymphoma Society. Cutaneous T-Cell Lymphoma. https://www.lls.org/sites/default/files/file_assets/PS96_CTCL_Booklet_Final.pdf. Accessed May 1, 2019.
(4) National Cancer Institute. Mogamulizumab. https://www.cancer.gov/publications/dictionaries/cancer-drug/def/mogamulizumab. Accessed May 1, 2019.

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