Safety of mogamulizumab in mycosis fungoides and sezary syndrome: final results from the Phase 3 Mavoric Study
dc.contributor.author | Kim, Y. | |
dc.contributor.author | Bagot, M. | |
dc.contributor.author | Zinzani, P. L. | |
dc.contributor.author | Morris, S. | |
dc.contributor.author | Ortiz-Romero, P. | |
dc.contributor.author | Magnolo, N. | |
dc.contributor.author | Scarisbrick, J. | |
dc.contributor.author | Dalle, S. | |
dc.contributor.author | Quaglino, P. | |
dc.contributor.author | Dreno, B. | |
dc.contributor.author | Beylot-Barry, M. | |
dc.contributor.author | Caballero, D. | |
dc.contributor.author | Cowan, Richard A | |
dc.contributor.author | Dummer, R. | |
dc.contributor.author | Iversen, L. | |
dc.contributor.author | Vermeer, M. | |
dc.contributor.author | Nicolay, J. | |
dc.date.accessioned | 2022-08-17T09:45:49Z | |
dc.date.available | 2022-08-17T09:45:49Z | |
dc.date.issued | 2022 | en |
dc.identifier.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. | en |
dc.identifier.uri | http://hdl.handle.net/10541/625487 | |
dc.description.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. | en |
dc.language.iso | en | en |
dc.title | Safety of mogamulizumab in mycosis fungoides and sezary syndrome: final results from the Phase 3 Mavoric Study | en |
dc.type | Meetings and Proceedings | en |
dc.contributor.department | Stanford Cancer Center, Stanford, Ca | en |
dc.identifier.journal | Acta Dermato-Venereologica | en |
dc.description.note | en] |