20 Aug FDA Approves Poteligeo® (mogamulizumab-kpkc) for T-Cell Lymphoma of the Skin
MedicalResearch.com Interview with:
Jeffrey S. Humphrey, MD
President of Kyowa Kirin Pharmaceutical Development, Inc
MedicalResearch.com: What is the background for this announcement? Would you briefly explain what is meant by Mycosis Fungoides and Sézary Syndrome?
Response: Kyowya Kirin has received FDA approval for Poteligeo (mogamulizumab), based on findings from the MAVORIC trial. Mogamulizumab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets CC chemokine receptor 4 (CCR4), for the treatment of the most common subtypes of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) and Sézary syndrome (SS).
MF and SS may have a profound and severe impact on quality of life, including a patient’s functional, emotional and social well-being, as symptoms may include a scaly red rash or light or dark patches in areas of the body that are not usually exposed to the sun; thin, reddened, eczema-like rash; thickened scaly, red skin (or plaques) or psoriasis-like rash; more advanced disease can include tumors (with significant thickness) on the skin, which may develop ulcers and become infected. Because CTCL manifests in skin lesions, it is often mistaken for other skin conditions (early stage MF and SS can be diagnosed as other skin conditions), which can delay conclusive diagnosis and treatment options.
MF is the most common subtype of CTCL, affecting 50-70% of individuals. In most patients diagnosed with early stage MF, the skin involvement does not progress, but in some patients, it will slowly progress. SS accounts for approximately 3% of CTCL cases and is a more aggressive, leukemic form of CTCL, affecting the blood, skin, lymph nodes and visceral organs
MedicalResearch.com: What should readers take away from your report?
Response: Patients with mycosis fungoides and Sézary syndrome may face years of disease management and the goal of treatment is to improve progression free survival. Current treatment options for CTCL include skin directed therapies consisting of phototherapy, radiation (local and entire skin surface), topical therapy and systemic therapies (affecting the entire body) including biologics, immune therapies and chemotherapies. The pivotal trial for Poteligeo, MAVORIC, demonstrated response across three of the four disease compartments of CTCL (skin, blood and lymph nodes).
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: With recent FDA approval, Poteligeo becomes an important new treatment option for patients living with MF and SS. Efficacy has been demonstrated via the results of the MAVORIC study—the largest randomized study of systemic treatment for CTCL to date and the first pivotal trial in CTCL using progression free survival (PFS) as the primary endpoint against an active comparator.
MedicalResearch.com: Is there anything else you would like to add?
Response: You can view a detailed breakdown of the MAVORIC findings as published in the most recent edition of Lancet Oncology HERE. The results showed that mogamulizumab demonstrated significantly superior PFS at a median of 7.7 months [95% CI, 5.7, 10.3] compared to 3.1 months with vorinostat [95% CI, 2.9, 4.1; hazard ratio 0.53, 95% CI 0.41– 0.6969; p<0.0001]. In addition to meeting the primary endpoint, ORR [28%; 95% CI, 21.6, 35.0 vs. 4.8%; 95% CI, 2.2, 9.0], median DOR [14.1 months, IQR 8.4-19.2 vs. 9.1 months (IQR 5.6 – not estimable)] and response by disease compartment were higher for patients assigned to mogamulizumab than for patients assigned to vorinostat.
August 8 2018
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Last Updated on August 20, 2018 by Marie Benz MD FAAD