Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician's choice in cutaneous T-cell lymphoma: Final data

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 symptomburdenwith no negative effects on quality of life.We report final data from ALCANZA (median follow-up, 45.9 months). Adults with previously treated CD30- expressingMF/C-ALCLwere randomly assigned to brentuximab vedotin (n564) or physician's choice (n 5 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 armwho experienced any-grade peripheral neuropathy, (grade 3, n 5 6; grade 4, n 5 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.