Ontak outdoes placebo in phase III trial for some CTCL (MF & Sezary) patients

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Results from a multi-center phase III trial examiniing the safety and efficacy of two doses of denileukin diftitox (Ontak) in patients with biopsy-confirmed CD25 assay-positive cutaneous T-cell lymphoma (CTCL), including both mycosis fungoides and Sezary Syndrome suggest merely that this recombinant protein can outperform a placebo.

Participating patients had received at least three prior therapies, and the trial's primary end point was overall response rate, meaning the total number of patients who responded to the therapy, to any degree.

For patients getting the denileukin diftitox, the ORR was 44%. Placebo, 15.9%.

Researcher's conclusion: "Denileukin diftitox had a significant and durable effect on ORR and PFS with an acceptable safety profile in patients with early- and late-stage CTCL".

By Ross Bonander

- Phase III Placebo-Controlled Trial of Denileukin Diftitox for Patients With Cutaneous T-Cell Lymphoma
- HemOncToday

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