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.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
131 enrolled.
Median follow-up 22.9 months
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective global response lasting at least 4 months (independent review)primary | Brentuximab vedotin | 64 | 56.3% | - | <0.0001 | link |
| Physician's choice (methotrexate or bexarotene) | 64 | 12.5% | ||||
| Grade 3-4 adverse events | Brentuximab vedotin | 66 | 41% | - | - | link |
| Physician's choice (methotrexate or bexarotene) | 62 | 47% |
Shares Randomised evidence for the T-cell lymphomas, including the ones that are not in Europe or North America, Takeda, Brentuximab vedotin, Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma) and the tag subtype-trials.
Shares Mycosis fungoides, Cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome), Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma) and the tag subtype-trials.
Shares Methotrexate and the tag subtype-trials.
Shares Pfizer (incl. Seagen) and the tag subtype-trials.
Shares Pfizer (incl. Seagen) and the tag subtype-trials.
Shares Antibody-drug conjugate (ADC) and the tag subtype-trials.
Shares Antibody-drug conjugate (ADC) and the tag subtype-trials.
Shares Antibody-drug conjugate (ADC) and the tag subtype-trials.