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BEDMINSTER, N.J., July 22, 2021 /PRNewswire/ -- Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) a global specialty pharmaceutical company, today announced new data from the MAVORIC trial evaluating the response to treatment with POTELIGEO^® (mogamulizumab-kpkc) in adults with mycosis fungoides (MF) or Sézary syndrome (SS) based on the extent of blood involvement at baseline. The post-hoc analysis, published in the Journal of the European Academy of Dermatology and Venereology, showed that patients with higher levels of blood involvement in MF or SS saw improved outcomes when treated with mogamulizumab compared to vorinostat.¹

"Managing any type of cutaneous T-cell lymphoma can be complex as the initial presentation and treatment is focused on the skin but the disease can travel into the blood," said study author Lauren C. Pinter-Brown MD, FACP, Chao Family Comprehensive Cancer Center, University of California, Irvine. "This latest analysis shows the need to be vigilant in monitoring a patient's blood so that the appropriate treatment can be used in patients with blood involvement to help improve outcomes."

The MAVORIC (Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL) trial is a pivotal open-label, international, Phase 3, randomized controlled trial that evaluated the safety and efficacy of mogamulizumab versus standard-of-care vorinostat in patients with previously treated MF or SS, the two most common types of cutaneous T-cell lymphoma (CTCL). It is the largest randomized study to compare systemic therapies in these subtypes of CTCL, a rare form of non-Hodgkin's lymphoma that can affect the skin, blood, lymph nodes and internal organs. The trial included CTCL patients at varying blood classification stages from those with no blood involvement (B0) to intermediate (B1) to the most severe patients (B2).² Blood involvement can occur in both SS and MF, especially in advanced disease, although it may also occur in early stages.³

The analysis showed that investigator-assessed progression-free survival (PFS) was significantly longer for patients treated with mogamulizumab compared to vorinostat, at 7.7 months and 3.1 months, respectively (P<0.0001). When data were stratified by blood classification, PFS was found to be significantly longer for mogamulizumab compared to vorinostat in patients with any blood involvement (B1 and B2 levels).¹

Overall response rate (ORR) was also higher with mogamulizumab than with vorinostat in the overall trial population (28.0% vs 4.8%, respectively; P < 0.0001) and significantly so for those with the highest level of blood involvement (B2: 37.4% vs 3.2%; P < 0.0001). Additionally, the difference in time-to-next-treatment was significantly longer for patients treated with mogamulizumab versus vorinostat with B1 (12.63 vs 3.07 months, P=0.0018) and B2 (13.07 vs 3.53 months, P<0.0001) level blood involvement.¹

Over the first 12 cycles of treatment, 81 patients treated with mogamulizumab (43.5%) had a ?50% improvement in skin response (modified Severity-Weighted Assessment Tool), versus 41 patients (22.0%) with vorinostat. In the mogamulizumab arm, complete or partial skin responses occurred more often among patients with B1 (14/31 [45.2%]) and B2 (51/91 [56.0%]) level blood involvement, compared to B0 (16/64 [25.0%]). Additionally, 16/91 (17.6%) mogamulizumab-treated patients with B2 level blood involvement had a 100% improvement compared to 3/93 (3.2%) patients treated with vorinostat.¹ Drug-related treatment-emergent adverse events were similar in patients regardless of blood involvement.¹

"Insights from this MAVORIC analysis drive home the importance of identifying and closely monitoring for blood involvement in patients with either MF or SS, to ensure treatment approaches are tailored as the disease evolves," said Eslie Dennis, M.D., SVP, Chief Medical Officer at Kyowa Kirin Inc. "These data demonstrate POTELIGEO provides benefit over vorinostat in all patients with this rare cancer, particularly for patients with blood involvement who are thought to have a worse prognosis."

Please see POTELIGEO Indication and Important Safety Information below.

U.S. Indication

POTELIGEO (mogamulizumab-kpkc) injection for intravenous infusion is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome 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/safety/medwatch/.

Please click here for full U.S. prescribing information.

About POTELIGEO (mogamulizumab-kpkc)

POTELIGEO is a humanized monoclonal antibody that recruits the body's own immune cells to kill CCR4+ (CC chemokine receptor 4) malignant T-cells.^4,5 CCR4 is overexpressed in Sézary syndrome and in mycosis fungoides at all stages.^6,7 POTELIGEO was produced using Kyowa Kirin's proprietary POTELLIGENT^® technology platform, which is associated with enhanced antibody-dependent cellular cytotoxicity.⁸

About Mycosis Fungoides and Sézary Syndrome

Mycosis fungoides and Sézary syndrome are the most common subtypes of cutaneous T-cell lymphoma.⁹ Most people with CTCL have MF (50%-70%), with some (~12%) experiencing rapid progression (or disease worsening) to advanced-stage MF.^10,11 In the early stages, many people only experience skin symptoms, which may include redness, rashes, and smaller patches.¹¹ If skin symptoms progress, larger areas of the skin will be affected with more intense redness, scaling, and lesions.⁹ In some people, CTCL can spread to other parts of the body such as the blood and lymph nodes.¹² SS is a rare (~3%), serious form of CTCL that affects the skin and blood with the most noticeable symptom being a red, itchy rash covering large portions of the body. ^13,14 Sometimes, it can spread to the lymph nodes and internal organs.^13,14

About Kyowa Kirin

Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with a more than 70-year heritage, the company applies cutting-edge science including an expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions – Japan, Asia Pacific, North America and EMEA/International – we focus on our purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity.  Since 2018, the company has received approval from the U.S. Food and Drug Administration for three first-in-class medicines. You can learn more about the business of Kyowa Kirin North America at kkna.kyowakirin.com.

References

1. R. Cowan, J.J. Scarisbrick et al. Efficacy and safety of mogamulizumab by patient baseline blood tumour burden: a post hoc analysis of the MAVORIC trial. Journal of the European Academy of Dermatology and Venerology. 2021. doi:10.1111/jdv.17523
2. Kim YH, 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 Oncol. 2018;19(9):1192-1204.
3. Scarisbrick JJ, Hodak E, Bagot M, et al. Blood classification and blood response criteria in mycosis fungoides and Sézary syndrome using flow cytometry: recommendations from the EORTC cutaneous lymphoma task force. Eur J Cancer. 2018;93:47-56. doi:10.1016/j.ejca.2018.01.076
4. POTELIGEO package insert. Kyowa Kirin Inc., Bedminster, NJ USA.
5. Ishida T, Iida S, Akatsuka Y, et al. The CC chemokine receptor 4 as a novel-specific molecular target for immunotherapy in adult T-cell leukemia/lymphoma. Clin Cancer Res. 2004;10:7529-7539.
6. Ferenczi K, Fuhlbrigge RC, Pinkus J, et al. Increased CCR4 expression in cutaneous T cell lymphoma. J Invest Dermatol. 2002;119:1405-1410.
7. Kallinich T, Muche JM, Qin S, et al. Chemokine receptor expression on neoplastic and reactive T cells in the skin at different stages of mycosis fungoides. J Invest Dermatol. 2003;121:1045-1052.
8. National Cancer Institute. Mogamulizamab. https://www.cancer.gov/publications/dictionaries/cancer-drug/def/mogamulizumab. Accessed October 2020.
9. Cutaneous T-Cell Lymphoma. Leukemia & Lymphoma Society. https://www.lls.org/sites/default/files/file_assets/PS96_CTCL_Booklet_Final.pdf.   
10. Talpur R, Singh L, Daulat S, et al. Long-term Outcomes of 1,263 Patients with Mycosis Fungoides and Sezary Syndrome from 1982 to 2009. Clin Can Res. 2012;18(18):5051-5060. doi:10.1158/1078-0432.ccr-12-0604.
11. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) - Primary Cutaneous Lymphomas. https://www.nccn.org/store/login/login.aspx?ReturnURL=https://www.nccn.org/professionals/physician_gls/pdf/primary_cutaneous.pdf.
12. Pulitzer M. Cutaneous T-cell Lymphoma. Clin in Laboratory Med. 2017;37(3):527-546. doi:10.1016/j.cll.2017.06.006.
13. Willemze R, Cerroni L, Kempf W, et al. The 2018 update of the WHO-EORTC classification for primary cutaneous lymphomas. Blood. 2019;133(16):1703-1714. doi:10.1182/blood-2018-11-881268
14. Olsen E, Vonderheid E, Pimpinelli N, et al. Revisions to the staging and classification of mycosis fungoides and Sézary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood. 2007;110(6):1713-1722. doi:10.1182/blood-2007-03-055749.

Contact:

Susan Thiele

Director, Brand Advocacy and Communications

Mobile:   +1 (908) 328-7117

susan.thiele.38@kyowakirin.com

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SOURCE Kyowa Kirin, Inc.