ALCANZA
ALCANZA showed that brentuximab vedotin produced lasting improvement in the skin disease of far more people with CD30-positive cutaneous T-cell lymphoma than the standard tablets methotrexate or bexarotene.
Overview
ALCANZA was an open-label phase 3 trial of 131 patients with CD30-expressing mycosis fungoides or primary cutaneous anaplastic large cell lymphoma who had received at least one prior systemic therapy. They were randomised to brentuximab vedotin every three weeks for up to 16 cycles or to the physician's choice of oral methotrexate or bexarotene. The primary endpoint was the rate of objective response lasting at least four months.
The durable response rate was several times higher with brentuximab vedotin, with longer progression-free survival and better symptom scores, at the cost of more peripheral neuropathy. It was approved in the United States in November 2017 for these two cutaneous T-cell lymphomas after prior systemic therapy, the first new drug for the disease shown superior to a standard in a randomised trial.
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