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In the Phase 3 trial, 241 patients with relapsed or refractory CLL wererandomly assigned to receive chemotherapy with fludarabine pluscyclophosphamide (Flu/Cy) with or without Genasense. This study achieved itsprimary endpoint, which was a statistically significant increase in theproportion of patients who achieved a complete or nodular partial response(CR) with the addition of Genasense to the Flu/Cy regimen. (17% vs. 7%;P=0.025). In addition, the median duration of CR was also significantlylonger for patients treated with Genasense (median not reached but estimatedto exceed 36 months vs. 22 months).
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Previous analyses showed a significant benefit in overall survival accruedto patients who attained CR. Extended followup has shown that all majorresponses (CR+PR) achieved with Genasense have now been associated withsignificantly increased overall survival compared with all major responsesachieved with chemotherapy alone (median = 56 months vs. 38 months,respectively). At 5 years, 22 of 49 (45%) responders in the Genasense groupremain alive compared with 13 of 54 (24%) responders in the chemotherapy-onlygroup (HR = 0.6; P = 0.038).
Moreover, with 5 years of follow-up, 12 of 20 patients (60%) in theGenasense group who achieved CR are alive, 5 of these patients remain incontinuous CR without relapse, and 2 additional patients have relapsed buthave not required additional therapy. By contrast, only 3 of 8 CR patients inthe chemotherapy-only group are alive, all 3 have relapsed, and all 3 haverequired additional anti-leukemic treatment.
The Company has requested a meeting with the Center for Drug Evaluationand Research (CDER) at the Food and Drug Administration (FDA) to review thisnew information.
A scientific report of the initial safety and efficacy findings from thisstudy was recently published (Journal of Clinical Oncology 25:1114, 2007).
About Chronic Lymphocytic Leukemia
CLL is the most common form of leukemia in adults. According to theAmerican Cancer Society, approximately 8,000 patients will be diagnosed thisyear. More than 60,000 people in the U.S. currently have CLL. The diseasearises in lymphocytes, a type of white blood cell that normally producesantibodies and serves important immune functions. Patients with CLL typicallydevelop symptoms that may progress over a period of years, ultimatelyproducing a generalized depression of immunity, marked increases in the sizeof spleen, liver and lymph nodes, and impaired production of other normalblood cells. Eventually, these problems may cause life-threateningcomplications, such as overwhelming infections and fatal bleeding. Moreinformation about CLL can be accessed at the website for the Lymphoma ResearchFoundation at: http://www.lymphoma.org .
About Genasense
Genasense inhibits production of Bcl-2, a protein made by cancer cellsthat is thought to block chemotherapy-induced apoptosis (programmed celldeath). By reducing the amount of Bcl-2 in cancer cells, Genasense mayenhance the effectiveness of current anticancer treatment. Genta is pursuing abroad clinical development program with Genasense evaluating its potential totreat various forms of cancer.
About Genta
Gent
