New Data from MAVORIC Trial Sheds Light on Key Characteristics of Long-term POTELIGEO® (mogamulizumab-kpkc) Responders with Specific Subtypes of Cutaneous T-cell Lymphoma
New Data from MAVORIC Trial Sheds Light on Key Characteristics of Long-term POTELIGEO® (mogamulizumab-kpkc) Responders with Specific Subtypes of Cutaneous T-cell Lymphoma - Separate analyses provide insight into the characteristics of patients who respond long-term and management of drug-related rash |
[06-December-2020] |
BEDMINSTER, N.J., Dec. 6, 2020 /PRNewswire/ -- Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) a global specialty pharmaceutical company, today announced data from two post-hoc analyses of the MAVORIC (Mogamulizumab anti-CCR4 Antibody Versus ComparatOR In CTCL) trial. The first evaluated the clinical and demographic characteristics of mogamulizumab-treated patients based on their duration of overall response (ORR), while the second explored the characteristics of patients who experienced mogamulizumab-associated rash. The findings showed patients who achieved a long-term (> 12 months) response with mogamulizumab treatment were more likely to have Sézary syndrome (stage IVA1) or blood involvement compared to patients with an ORR of shorter duration. Further, among those who experienced treatment-related rash (n=44), the data show 80% were able to continue treatment for >6 months following the resolution of initial rash. MAVORIC was 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 mycosis fungoides (MF), or Sézary syndrome (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. "Since CTCL is a chronic condition that is typically managed over time, how and when we sequence therapies is critical," said study author, Youn Kim, M.D., from the Stanford Cancer Center. "These data contribute to our understanding of mogamulizumab treatment in patients who have SS or advanced MF with blood involvement. Further, it shows that with proper evaluation and management of treatment-related rash, it may allow some patients to continue with treatment with durable responses." Patient Characteristics of Long-term Responders to Mogamulizumab: Results from the MAVORIC Study (Abstract 2082) Among patients randomized to mogamulizumab (n=186), ORRs lasting ≥4, ≥6, ≥8, and ≥12 months were seen in 25.3%, 21.0%, 16.1%, and 10.8%, respectively. Mogamulizumab treatment resulted in significantly higher long-term overall response rates in both blood and skin measures compared to vorinostat. Responses in blood and skin lasting ≥6 months were seen in 49.2% and 27.4% of mogamulizumab-treated patients, respectively, compared with 5.6% and 7.5% with vorinostat. When compared with patients with shorter responses, patients who achieved long-term responses were more likely to have SS (stage IVA1) or blood involvement. Characterization and Outcomes in Patients with Mogamulizumab-Associated Skin Reactions in the MAVORIC Trial (Abstract 1169) Among mogamulizumab-treated patients, 24% (44/184) reported treatment-emergent rash, the majority Grade 1/2, leading to discontinuation in 13 patients.1 Patients who experienced mogamulizumab-associated rash were more likely to be diagnosed with SS (25/44, 56.8%) than MF (19/44, 43.2%). The proportion of patients with SS who responded to mogamulizumab and experienced rash (14/25, 56%) was significantly higher than the proportion of responders without rash (16/54, 30%) (P=0.02). Overall, 80% of patients (35/44) were able to continue treatment with a median duration of exposure of >6 months after resolution of their initial rash. Please see POTELIGEO Indication and Important Safety Information below. U.S. Indication Important Safety Information Warnings and Precautions:
Adverse Reactions:
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) About Mycosis Fungoides Sézary Syndrome About Kyowa Kirin 1 Kim YH, et al. Lancet Oncol. 2018;19(9):1192-204 2 POTELIGEO package insert. Kyowa Kirin Inc., Bedminster, NJ USA. 3 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. 4 Ferenczi K, Fuhlbrigge RC, Pinkus J, et al. Increased CCR4 expression in cutaneous T cell lymphoma. J Invest Dermatol. 2002;119:1405-1410. 5 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. 6 National Cancer Institute. Mogamulizamab. https://www.cancer.gov/publications/dictionaries/cancer-drug/def/mogamulizumab. Accessed October 2020. 7 Cutaneous T-Cell Lymphoma. Leukemia & Lymphoma Society. https://www.lls.org/sites/default/files/file_assets/PS96_CTCL_Booklet_Final.pdf. 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 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. 10 Pulitzer M. Cutaneous T-cell Lymphoma. Clin in Laboratory Med. 2017;37(3):527-546. doi:10.1016/j.cll.2017.06.006. 11 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 12 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. SOURCE Kyowa Kirin, Inc. | ||
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