Kyowa Kirin Launches New Efforts to Educate and Engage Physicians and Patients with Rare Forms of Cutaneous T-Cell Lymphoma About Treatment with POTELIGEO® (mogamulizumab-kpkc)

- Treat the Blood. Treat the Skin. physician campaign reinforces importance of regular blood monitoring and a tailored treatment approach in mycosis fungoides and Sézary syndrome

- POTELIGEO ambassadors address patients' need to learn from others with similar, rare diagnosis(1)

BEDMINSTER, N.J., Sept. 23, 2021 /PRNewswire/ -- Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company, today announced the launch of two efforts focused on increasing understanding of mycosis fungoides (MF) and Sézary syndrome (SS), two subtypes of cutaneous T-cell lymphoma (CTCL),² and the role of POTELIGEO^® (mogamulizumab-kpkc) in treating them.³ Aimed at physicians, the new Treat the Blood. Treat the Skin. omni-channel campaign seeks to educate about the importance of measuring and monitoring blood involvement to inform treatment and potentially impact patient outcomes in MF and SS. To reach patients, POTELIGEO patient ambassadors will share their CTCL journeys and experiences on treatment through video testimonials and other educational programming. The launch of both initiatives coincides with Blood Cancer Awareness Month.

"To have a profound impact in a rare disease like CTCL, it's important to invest in education and programming that helps to advance disease awareness, recognition and management," said Sue Smith, Vice President, North American Oncology Franchise Head, Kyowa Kirin, Inc. "With increasing blood burden linked to poorer prognosis in both mycosis fungoides and Sézary syndrome, it's critical that the blood is monitored for disease progression and response to treatment. Our physician effort is focused on increasing understanding of the value of routine blood testing, and the proven efficacy of POTELIGEO in treating MF and SS symptoms."^3,4-6

CTCL is a rare type of blood cancer that affects the body's T cells. Because it first appears on the skin, it is often mistaken for common skin conditions like eczema or psoriasis, which can delay diagnosis by years or even decades.⁷ Most patients have mycosis fungoides, a chronic and typically slow growing cancer that initially manifests in the skin but can spread within the skin or to other areas, including the blood, in 30% of cases.^2,5,8,10 Sézary syndrome is a rare (<5%), serious form of CTCL that affects the skin and blood from the start.¹¹ Increasing blood burden in CTCL has been associated with worsening overall survival, disease-specific survival, and an increased risk of disease progression.^5,8,12

Encouraging Physicians to Test More
The new Treat the Blood. Treat the Skin. campaign explains the value of understanding patients' blood burden when determining appropriate treatment selection in MF and SS. Given that skin inflammation is often focused on as the source of discomfort and visible sign of disease, the campaign aims to call attention to the potential risk associated with blood involvement in MF and SS patients.^7,13 A recent post-hoc analysis of data from the phase 3 MAVORIC trial published in the Journal of the European Academy of Dermatology and Venereology, evaluated the efficacy and safety of POTELIGEO in MF and SS across all levels of blood classifications compared to vorinostat.⁴

The campaign will reach healthcare professionals through a targeted mix of personal, print and digital communications supported by a new healthcare professional website (www.poteligeohcp.com) that reviews POTELIGEO's efficacy and safety in MF and SS patients with varying levels of blood involvement.^1,4 Peer-to-peer education featuring experts in the field is planned to further extend the reach of the initiative is planned for early 2022.

Bringing Real Patient Experiences to Life
Additional efforts are being made to educate patients about POTELIGEO as a treatment option.¹ Given CTCL is a rare disease, patients are eager to connect with and learn from others who share the same diagnosis. Research indicates they rely heavily on advocacy groups and online forums for information when assessing and evaluating treatment options.² To address the need for more information about patient experiences on treatment, educational content and programming has been created featuring the stories of real POTELIGEO patients – including their journey to diagnosis, experiences on treatment and what motivates them to never give up.

Jeff, POTELIGEO patient ambassador living with MF

"I wanted to share my story to encourage others to never give up, to keep pushing for answers," said Jeff, POTELIGEO ambassador living with mycosis fungoides. "It's easy to feel overwhelmed, to say it's just not going to work and to give up. By learning how to advocate for myself, I was able to finally find the right specialists, the right diagnosis and ultimately, the right treatment for me."

Jeff's and other patient stories will be viewable on www.poteligeo.com, and other online channels. Additional events with patient speakers are planned for 2022.

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.^1,14 CCR4 is overexpressed in Sézary syndrome and in mycosis fungoides at all stages.^15,16 POTELIGEO was produced using Kyowa Kirin's proprietary POTELLIGENT^® technology platform, which is associated with enhanced antibody-dependent cellular cytotoxicity.¹⁶

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. POTELIGEO 3D Patient Journey Research. Data on file. Kyowa Kirin Inc., Bedminster, NJ USA.
2. Cutaneous T-Cell Lymphoma. Leukemia & Lymphoma Society. https://www.lls.org/sites/default/files/file_assets/PS96_CTCL_Booklet_Final.pdf.  
3. POTELIGEO package insert. Kyowa Kirin Inc., Bedminster, NJ USA.
4. 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
5. Agar NS, Wedgeworth E, Crichton S, et al. Survival outcomes and prognostic factors in mycosis fungoides/ Sézary syndrome: validation of the revised Internal Society for Cutaneous Lymphomas/European Organisation for Research and Treatment of Cancer staging proposal. J. Clin Oncol. 2010;28(31):4730-4739.
6. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Primary Cutaneous Lymphomas. V.1.2021. National Comprehensive Cancer Network, Inc. 2021. https://www.nccn.org/login?ReturnURL=https://www.nccn.org/professionals/physician_gls/pdf/primary_cutaneous.pdf.
7. Cutaneous Lymphoma Foundation. Understanding My Diagnosis, Mycosis Fungoides. Accessed 9.9.21  https://www.clfoundation.org/cutaneous-t-cell-lymphoma.
8. 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.
9. A Patient's Guide to Understanding Cutaneous Lymphoma. Cutaneous Lymphoma Foundation. 2021. Accessed 9.9.21 https://www.clfoundation.org/sites/default/files/2017-08/2013_guide.pdf.
10. Amorim GM, Niemeyer-Corbellini JP, Quintella DC, Cuzzi T, Ramos-E-Silva M. Clinical and epidemiological profile of patients with early-stage mycosis fungoides. An Bras Dermatol. 2018;93(4):546-552.
11. Cutaneous Lymphoma Foundation. Understanding My Diagnosis, Sézary syndrome. Accessed 9.9.21. https://www.clfoundation.org/sezary-syndrome.
12. 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.
13. National Organization for Rare Disorders. Rare Disease Database, Mycosis Fungoides. Accessed 9.9.21 https://rarediseases.org/rare-diseases/mycosis-fungoides/
14. 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.
15. Ferenczi K, Fuhlbrigge RC, Pinkus J, et al. Increased CCR4 expression in cutaneous T cell lymphoma. J Invest Dermatol. 2002;119:1405-1410.
16. 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.

SOURCE Kyowa Kirin, Inc.