An Australian-led trial has shown a new drug works in almost five times as many patients, and has more durable benefits, compared to standard therapy for a rare skin-related cancer. The multi-centre Phase 3 clinical trial involved patients with cutaneous T-cell lymphoma, a cancer which causes debilitating and worsening skin problems and for which there is no known cure.
Around 130 patients across 52 international trial sites, including at Peter Mac, were enrolled in the trial and randomly assigned into groups treated with either the new drug - brentuximab vedotin - or standard therapy.
More than half (56.3%) of those treated with brentuximab vedotin went on to show a beneficial response lasting four months or more. This was compared to 12.5% for patients who received a standard therapy.
Longer-term follow-up also showed a major improvement in progression-free survival – at 16.7 months for patients treated with the new drug compared to 3.5 months for standard therapy.
A paper describing the trial and these outcomes is published online in The Lancet today.
“We saw both a large increase in the number of patients who responded well to the new drug and, importantly, their responses were durable and lasted a lot longer than expected for this hard-to-treat cancer,” says Professor Miles Prince, trial leader and specialist haematologist at Peter MacCallum Cancer Centre.
“These impressive results point to a new and more effective treatment option for these patients, whom standard therapies have to date offered only unreliable or short-term benefits.”
The new drug was not associated with any new or unexpected toxicities compared to standard therapy. Brentuximab vedotin is already approved for use in other lymphomas including the more common Hodgkins lymphoma, potentially fast-tracking its approval for use in cutaneous T-cell lymphoma.