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00925njm 22002777a 4500 dc Horwitz, Steven M. author Scarisbrick, Julia J. author Dummer, Reinhard author Whittaker, Sean author Duvic, Madeleine author Kim, Youn H. author Quaglino, Pietro author Zinzani, Pier Luigi author Bechter, Oliver author Eradat, Herbert author Pinter-Brown, Lauren author Akilov, Oleg E. author Geskin, Larisa author Sanches, Jose A. author Ortiz Romero, Pablo Luis author Weichenthal, Michael author Fisher, David C. author Walewski, Jan author Trotman, Judith author Taylor, Kerry author Dalle, Stephane author Stadler, Rudolf author Lisano, Julie author Bunn, Veronica author Little, Meredith author Prince, H. Miles author 2021-12-06 The primary analysis of the phase 3 ALCANZA trial showed significantly improved objective responses lasting ≥4 months (ORR4; primary endpoint) and progression-free survival (PFS) with brentuximab vedotin vs physician's choice (methotrexate or bexarotene) in CD30-expressing mycosis fungoides (MF) or primary cutaneous anaplastic large-cell lymphoma (C-ALCL). Cutaneous T-cell lymphomas often cause pruritus and pain; brentuximab vedotin improved skin symptom burden with no negative effects on quality of life. We report final data from ALCANZA (median follow-up, 45.9 months). Adults with previously treated CD30-expressing MF/C-ALCL were randomly assigned to brentuximab vedotin (n = 64) or physician's choice (n = 64). Final data demonstrated improved responses per independent review facility with brentuximab vedotin vs physician's choice: ORR4; 54.7% vs 12.5% (P < .001); complete response, 17.2% vs 1.6% (P = .002). Median PFS with brentuximab vedotin vs physician's choice was 16.7 months vs 3.5 months (P < .001). Median time to the next treatment was significantly longer with brentuximab vedotin than with physician's choice (14.2 vs 5.6 months; hazard ratio, 0.27; 95% confidence interval, 0.17-0.42; P < .001). Of 44 patients in the brentuximab vedotin arm who experienced any-grade peripheral neuropathy, (grade 3, n = 6; grade 4, n = 0), 86% (38 of 44) had complete resolution (26 of 44) or improvement to grades 1 and 2 (12 of 44). Peripheral neuropathy was ongoing in 18 patients (all grades 1-2). These final analyses confirm improved, clinically meaningful, durable responses and longer PFS with brentuximab vedotin vs physician's choice in CD30-expressing MF or C-ALCL. This trial was registered at https://www.clinicaltrials.gov as #NCT01578499. Horwitz SM, Scarisbrick JJ, Dummer R, Whittaker S, Duvic M, Kim YH, et al. Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician’s choice in cutaneous T-cell lymphoma: final data. Blood Advances 2021;5:5098–106. https://doi.org/10.1182/bloodadvances.2021004710. 2473-9529 2473-9537 10.1182/bloodadvances.2021004710 https://hdl.handle.net/20.500.14352/131094 https://doi.org/10.1182/BLOODADVANCES.2021004710 https://ashpublications.org/bloodadvances/article/5/23/5098/476861/Randomized-phase-3-ALCANZA-study-of-brentuximab Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician’s choice in cutaneous T-cell lymphoma: final data