Updated combined analysis of two phase II studies of brentuximab vedotin in patients with mycosis fungoides and Sézary syndrome

Huen, Auris; Rahbar, Zahra; Talpur, Rakhshandra; Li, S.; Hong, Eric; Tetzlaff, Michael T.; Duvic, M.; Kim, Y.H.

doi:10.1016/j.ejca.2018.07.305

Cited by 2 publications

(1 citation statement)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…These findings therefore support the primary analysis of ALCANZA and are also consistent with the results of other smaller studies of brentuximab vedotin in relapsed/refractory CTCL. 6,15,19,20 These single-arm phase 2 studies included more CTCL subtypes not studied in ALCANZA such as Sézary syndrome (SS) and lymphomatoid papulosis (LyP), and lower CD30 levels, down to 0%. Brentuximab vedotin at the standard dose demonstrated significant clinical activity in treatment-refractory or advanced MF, SS, or LyP with a wide range of CD30 expression levels.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2021

View full text Add to dashboard Cite

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 randomized 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 next treatment was significantly longer with brentuximab vedotin than with physician's choice (14.2 vs 5.6 months; hazard ratio, 0.27; 95% CI, 0.17-0.42; P < .001). Of 44 patients in the brentuximab vedotin arm who experienced any-grade peripheral neuropathy (PN), (grade 3, n = 6; grade 4, n = 0), 86% (38/44) had complete resolution (26/44) or improvement to grade 1-2 (12/44). PN was ongoing in 18 patients (all grade 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/ct2/show/NCT01578499 as #NCT01578499.

show abstract

Section: Discussionmentioning

confidence: 99%