March 31st, 2010

Ontak Delays Progression of Patients with Cutaneous T-cell Lymphoma


Among patients with cutaneous T-cell lymphoma, treatment with the drug Ontak® (denileukin diftitox) slows disease progression. These results were reported in the Journal of Clinical Oncology.

T-cell lymphoma, a type of non-Hodgkin’s lymphoma, originates in immune cells called T-cells. Cutaneous T-cell lymphoma (CTCL) is a type of T-cell lymphoma that affects the skin.

Ontak is a biologic agent that is approved for the treatment of cutaneous T-cell lymphoma. Ontak is comprised of two separate proteins: a toxin and interleukin-2 (IL-2), a protein produced by the immune system. The IL-2 segment of Ontak binds preferentially to CTCL cells and delivers the toxin into the cell. Once inside, the toxin destroys the cell.

This recent Phase III trial involved 144 patients with CTCL who had received up to three prior treatments. Participants were divided into three groups: those receiving 9 micrograms (lower dose) of Ontak; those receiving 18 micrograms (higher dose); and those receiving placebo. Ontak was delivered for five days at a rate of one infusion per day for up to eight courses every three weeks. Treatment was stopped if disease progressed or side effects were unacceptable.

  • Overall response rates were higher for the two groups receiving Ontak compared with the placebo group, with the highest response among patients receiving the higher dose: 49% for the higher-dose group, 38% for the lower-dose group, and 16% for the placebo group.
  • Risk of disease progression was reduced by 73% among patients in the higher-dose group compared with the placebo group, making progression-free survival longer among patients receiving Ontak.
  • Ontak was associated with more side effects than placebo, but, overall, severe side effects were relatively low.

The researchers concluded that Ontak extends progression-free survival and is relatively safe for patients with CTCL.

Reference: Prince HM, Duvic M, et al. Phase III Placebo-Controlled Trial of Denileukin Diftitox for Patients With Cutaneous T-Cell Lymphoma. Journal of Clinical Oncology [early online publication]. March 8, 2010.

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