Brentuximab Vedotin vs Physician’s Choice in CD30-Positive Cutaneous T-Cell Lymphoma
The phase III ALCANZA trial has shown that brentuximab vedotin (Adcetris) produces a higher global response rate vs physician’s choice of therapy in previously treated CD30-positive cutaneous T-cell lymphomas. These results were reported by Prince et al in The Lancet.
Study Details
In this open-label trial, 131 adult patients with CD30-positive mycosis fungoides or primary cutaneous anaplastic large cell lymphoma from 52 sites in 13 countries were randomized between August 2012 and July 2015 to receive brentuximab vedotin at 1.8 mg/kg intravenously once every 3 weeks for up to 16 3-week cycles (n = 66) or physician’s choice (n = 65) of oral methotrexate at 5 to 50 mg once per week or oral bexarotene (Targretin) at 300 mg/m2/d for up to 48 weeks. A total of 128 patients, consisting of 64 in each group, were included in the efficacy intention-to-treat analysis. The primary endpoint was the proportion of patients with objective global response lasting ≥ 4 months on independent review facility assessment in the intention-to-treat population.
Response Rates and Adverse Events
Median follow-up was 22.9 months. Objective global response of ≥ 4 months occurred in 56.3% of the brentuximab vedotin group vs 12.5% of the physician’s choice group (between-group difference = 43.8%, P < .0001).
Grade 3 or 4 adverse events occurred in 41% of the brentuximab vedotin group and 47% of the physician’s choice group. Peripheral neuropathy was reported in 67% of the brentuximab vedotin group (grade 2 in 32%, grade 3 in 9%) and 6% of the physician’s choice group. Four on-treatment deaths occurred in the brentuximab vedotin group, with one considered related to study treatment; no on-treatment deaths occurred in the physician’s choice group.
The investigators concluded: “Significant improvement in objective response lasting at least 4 months was seen with brentuximab vedotin versus physician’s choice of methotrexate or bexarotene.”
The study was funded by Millennium Pharmaceuticals Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd) and Seattle Genetics Inc.
H. Miles Prince, MD, of Peter MacCallum Cancer Centre, Melbourne, is the corresponding author of The Lancet article.
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