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Genasense Plus Chemotherapy Is Associated With Prolonged Survival in Patients With Relapsed/Refractory CLL Who Achieve Complete Remission
Date:12/10/2007

ients who achieved CR in the Phase 3 trial. Previously, a survival benefit had been demonstrated only in CR patients who were prospectively stratified prior to randomization as being "non-refractory" to chemotherapy using a standard definition. (The prior data can be accessed at: http://www.genta.com/index.php?option=com_content&task=view&id=60&Itemid=73 &CI D=44&SHID=&COID=). (To view this Web site please cut and paste the URL into your browser.) The new data show that this superior survival benefit for Genasense-treated patients extends to all patients who achieved CR/nPR. These data are presented in the table below.

Survival Genasense/Flu/Cy Flu/Cy p-value

1 year 20 8 0.016

2 years 17 8 0.06

3 years 16 4 0.005

4 years 12 2 0.006

Safety

Grade 3 or Grade 4 adverse events that occurred during treatment or within 30 days from last treatment in an increased percentage of patients in the Genasense group included, but were not limited to, thrombocytopenia, nausea, and intravenous-catheter complications. Adverse events resulted in discontinuation of therapy in an equal percentage of patients in both groups. Nine patients in the Genasense group and 5 patients in the chemotherapy-alone group had adverse events that resulted in death, including two patients in the Genasense group who died from complications associated with tumor lysis and infusion-related reactions.

A scientific report of the safety and efficacy findings from this study was published earlier this year in the Journal of Clinical Oncology (25:1114, 2007).

Regulatory History of Genasense in CLL

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SOURCE Genta Incorporated
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