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news.Cephalon has reported that Treanda was able to demonstrate its efficacy against chronic lymphocytic leukemia and indolent non-Hodgkin's lymphoma in two different clinical studies.
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In the randomized, international, multicenter, open-label Phase III clinical trial that evaluated the safety and efficacy of bendamustine compared to chlorambucil in previously untreated patients with B- chronic lymphocytic leukemia (CLL), Treanda (bendamustine) demonstrated significantly better outcomes in both of the primary endpoints: overall response rate and progression-free survival (PFS).
Overall response rate was higher with bendamustine than with chlorambucil (68% versus 39%) (p<0.0001) with a strong complete response rate of 30% compared to 2%, a nodular partial response of 10% compared to 3%, and a partial response of 28% compared to 34%, respectively. Bendamustine significantly improved PFS compared to chlorambucil (median PFS 21.7 months vs. 9.3 months (p<.0001)). The median duration of response in the patients treated with bendamustine was 18.9 months compared to 6.1 months for those patients treated with chlorambucil. Bendamustine demonstrated a manageable tolerability profile. The other Phase III, multicenter, single-arm study evaluated the efficacy and safety of single-agent bendamustine in 100 patients with indolent non-Hodgkin's lymphoma (NHL) whose disease has progressed during or following treatment with rituximab. In this second pivotal study that involved 100 patients with indolent NHL whose disease has progressed during or following treatment with rituximab, or a rituximab-containing regimen, as assessed by an independent radiological committee, 75 patients had a response. Of those patients who responded to treatment, 14 had a complete response and three had an unconfirmed complete response. The median duration of response was 9.2 months. Bendamustine demonstrated a manageable tolerability profile. Treanda is a novel investigational chemotherapy that is currently under priority review by the FDA. Lesley Russell, executive vice president, worldwide medical and regulatory operations, Cephalon, said: "If approved, we believe Treanda will be an important new treatment option for patients with CLL."