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TREANDA Significantly Improves Clinical Outcomes in Patients with Chronic Lymphocytic Leukemia Compared to Chlorambucil
Date:12/10/2007

Data from Pivotal Study Show Bendamustine Produced a Significant Increase

in Overall Response Rate and Progression Free Survival

FRAZER, Pa., Dec. 10 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) announced today that in a pivotal study of treatment-naive patients with chronic lymphocytic leukemia (CLL), those who received TREANDA (bendamustine HCl) had better clinical outcomes compared to patients treated with chlorambucil, an FDA-approved therapy for patients with CLL. TREANDA(R) is a novel investigational chemotherapy that is currently under priority review by the U.S. Food and Drug Administration (FDA). CLL is a slowly progressing blood and bone marrow disease with an estimated 15,000 new cases diagnosed every year in the United States, according to the National Cancer Institute. The final data from this large, international, multi-center study were presented at the 49th Annual Meeting of the American Society of Hematology (ASH) in Atlanta, GA [Poster # 233-II; Abstract #2043].

"In this study, bendamustine was more effective than chlorambucil in achieving remissions in treatment-naive patients with CLL," said Dr. Wolfgang Knauf, Onkologische Gemeinschaftspraxis, Frankfurt, Germany and lead investigator of this study. "On the basis of these positive results, bendamustine could be an important first-line chemotherapy option for patients with CLL."

Bendamustine demonstrated significantly better outcomes in both of the primary endpoints: overall response rate and progression-free survival (PFS). Overall response rate was significantly higher with bendamustine than with chlorambucil (68% vs. 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
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SOURCE Cephalon, Inc.
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