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.
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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.”
Reference
- 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]
