Brentuximab vedotin (BV) significantly prolonged progression-free survival (PFS) with higher response rates compared with methotrexate or bexarotene among patients with cutaneous T cell lymphoma (CTCL), according to the results of the ALCANZA study (ClinicalTrials.gov Identifier: NCT01578499) published in the Lancet.1
Methotrexate and bexarotene are commonly used for systemic treatment of CTCL, but the response rate is about 30% and lasts for about 4 to 6 months. BV is currently approved for the treatment of systemic anaplastic large-cell lymphoma and relapsed/refractory Hodgkin lymphoma.
The international, open-label, phase 3 ALCANZA trial randomly assigned 131 patients with previously treated CTCL to receive BV or physician’s choice of oral methotrexate or oral bexarotene for up to 48 weeks.
The median CD30 expression level at baseline was 31.3% (range, 12.5 to 60.0). Patients had mycosis fungoides (76%) or cutaneous anaplastic large-cell lymphoma (24%).
The objective response rate (ORR) lasting at least 4 months was significantly higher in the BV arm with a rate of 56.3% compared with 12.5% among patients receiving physician’s choice (difference, 43.8%; 95% CI, 29.1-58.4; P < .0001).
The PFS per US Food and Drug Administration (FDA) criteria among the intention-to-treat population was significantly longer with BV, with a median of 17.2 months compared with 3.5 months with physician’s choice (hazard ratio, 0.181; 95% CI, 0.101-0.324; P < .0001).
The median duration of response among responders was 15.1 months (95% CI, 9.7-25.5 months) with BV compared with 18.3 months (95% CI, 3.5-18.4 months) with physician’s choice.
Patient-reported symptoms were also lower with BV compared with physician’s choice.
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The adverse event (AE) that occurred most frequently with BV was peripheral sensory neuropathy (45%), a known AE associated with BV. The rates of serious AEs were similar between arms (29% in both). Discontinuation due to AEs occurred among 24% of patients in the BV arm and 8% in the physician’s choice arm.
According to the authors, “these data provide compelling evidence favoring BV over methotrexate or bexarotene for the treatment of relapsed or refractory CD30-positive CTCL.”
- Prince HM, Kim YH, Horwitz SM, et al. Brentuximab vedotin or physician’s choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Jun 6. doi: 10.1016/S0140-6736(17)31266-7 [Epub ahead of print]