Safety of mogamulizumab in mycosis fungoides and sezary syndrome: final results from the Phase 3 Mavoric Study
Kim, Y. Bagot, M. Zinzani, P. L. Morris, S. Ortiz-Romero, P. Magnolo, N. Scarisbrick, J. Dalle, S. Quaglino, P. Dreno, B.
Kim, Y.
Bagot, M.
Zinzani, P. L.
Morris, S.
Ortiz-Romero, P.
Magnolo, N.
Scarisbrick, J.
Dalle, S.
Quaglino, P.
Dreno, B.
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Abstract
Purpose: MAVORIC was an open-label, phase3 study evaluating safety and efficacy of mogamuli-zumab vs vorinostat in previously-treated mycosis fungoides/Sézary syndrome (NCT01728805). This report provides final safety results (January 3, 2019).Methods: Patients were randomized 1:1 to mo-gamulizumab 1.0 mg/kg intravenously on Days 1, 8, 15, 22 of the first-cycle and Days 1 and 15 of subsequent cycles or vorinostat 400 mg orally once daily. Patients could crossover from vorinostat to mogamulizumab upon progression/intolerable toxicity. Results: 372 patients were randomized, and 370 included for safety analysis (mogamulizumab:184; vorinostat:186). Median follow-up was 34.5 months in the randomized part of the study. Types and frequencies of adverse events (AEs) attributable to mogamulizumab (per Investigator assessment) included infusion-related reaction (33.2%[61/184]), drug erup-tion(23.9%[44/184]), and fatigue(18.5%[34/184]); and for vori-nostat, diarrhea(55.4%[103/186]), nausea(38.2%[71/186]), and fatigue(33.3%[62/186]). In cross-over patients, the most frequently reported AEs attributable to mogamulizumab were infusion-related reaction(37.8%[51/135]), drug eruption(24.4%[33/135]), fatigue(7.4%[10/135]), increased alanine aminotransfe-rase(7.4%[10/135]), and increased aspartate aminotransfe-rase(7.4%[10/135]). Discontinuation rates due to AEs were: mogamulizumab(21.7%[40/184]); vorinostat(23.7%[44/186]); crossover(25.9%[35/135]). The most common AEs leading to discontinuation were drug eruption with mogamulizu-mab(7.1%[13/184]), and fatigue with vorinostat(4.3%[8/186]). Rates of drug-related serious treatment-emergent adverse events (TEAEs) were mogamulizumab(19.6%[36/184]); vori-nostat(16.7%[31/186]); crossover(11.9%[16/135]. After data cutoff for the primary analysis, 2 patients experienced TEAEs with an outcome of death, all considered unrelated to study treatment per Investigator: 1 patient randomized to mogamulizumab (de-creased appetite, general health deterioration, hypoalbuminemia) and 1 crossover patient (cerebral hemorrhage).Conclusions: Mogamulizumab was generally well-tolerated. Longer follow-up and treatment exposure did not identify any new safety signals.
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Date
2022
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Meetings and Proceedings
Citation
Kim Y, Bagot M, Zinzani PL, Morris S, Ortiz-Romero P, Magnolo N, et al. Safety of Mogamulizumab in Mycosis Fungoides and Sezary Syndrome: Final Results from the Phase 3 Mavoric Study. Acta Dermato-Venereologica. 2022;102:40-1. PubMed PMID: WOS:000813311700103.