( o prove superiority versus placeboin e...)Ontak (denileukin diftitox) Achieves 49.1% Overall Response Rate in,Phase III Trial of Cutaneous T-Cell Lymphoma (CTCL),Health

o prove superiority versus placebo in eliciting a clinical response in patients with CTCL," commented Miles Prince, MD, Chair of Cancer Services at Peter MacCallum Cancer Centre, Melbourne, Australia, and a lead investigator of this trial. "This study also showed an extension in progression-free survival for these patients, a secondary trial endpoint."

In the trial, 144 patients with CTCL, whose malignant cells expressed the CD25 component of the IL-2 receptor, were randomized to receive either of two doses of ONTAK [9 mcg/kg/day (n=45) or 18 mcg g/kg/day (n=55)] or placebo (n=44) for up to eight cycles of therapy (median cycles for all patients = 6; range for all patients is 1-11). Per protocol, eligible patients had received three or less prior treatments and had stages Ia to III disease. Both ONTAK doses were superior to placebo in a dose-dependent fashion. The response rate was 37.8% (95% confidence interval: 23.8, 53.5) with the lower ONTAK dose (p=0.0297 vs. placebo), 49.1% (95% confidence interval: 35.4, 62.9) with the higher ONTAK dose (p=0.0015 vs. placebo) compared to 15.9% (95% confidence interval: 6.6, 30.1) with placebo. Whereas 11.1% of patients on the lower ONTAK dose and 9.1% of those on the higher ONTAK dose had either a complete response to treatment or clinical complete response, only 2.3% of patients receiving placebo experienced this benefit. The proportion of patients experiencing progressive disease were 26.7% for the lower ONTAK dose, 16.4% for the higher ONTAK dose and 52.3% for placebo. Both ONTAK doses were also better than placebo with regard to median time of progression-free survival: 794 days (95% confidence interval: 155.0, not estimable) for the lower ONTAK dose, greater than 971 days (median not reached) for the higher ONTAK dose, and 124 days (95% confidence interval: 92.0, 176.0) for placebo.

The most common adverse events in the ONTAK-treated patients included fever (56%), nausea (54%), fatigue (45%), rigors (45%),
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