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Genasense(R) Data in Melanoma to be Presented in Opening Session at First Worldwide Melanoma Center Meeting of the European Association of Dermato-Oncology
Date:9/5/2007

a's lead anticancer drug, is a novel targeted therapy that blocks the production of Bcl-2, a protein that appears to be a fundamental cause of cancer treatment resistance. By knocking down Bcl-2, Genasense may enhance the effectiveness of chemotherapy in patients with advanced melanoma. Genasense in melanoma has Orphan Drug designations in Australia and the U.S., along with Fast Track designation in the U.S.

In its initial Phase 3 trial, Genta performed the largest randomized controlled trial that has ever been conducted in patients with advanced melanoma. In that trial, 771 patients were randomly assigned to receive chemotherapy with DTIC alone or in combination with Genasense. A scientific article that describes efficacy and safety results from this study can be accessed at: http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1.

In that trial, patients were prospectively stratified according to levels of a blood enzyme known as LDH. Further analysis of this study showed that maximum benefit accrued to patients whose LDH biomarker did not exceed 80% of the upper limit of normal. Efficacy results in this group of 274 patients, which are the focus of the confirmatory AGENDA trial, are displayed in the table below. (The hazard ratios indicate that the addition of Genasense to DTIC was associated with a 42% reduction in the risk of disease progression and a 36% reduction in risk of death.)

Endpoint Genasense/DTIC DTIC Hazard P

Ratio

Overall response 20.8 % 7.2 % 0.002

Durable response 10.7 % 2.4 % 0.007

Progression-free survival,

median 3.6 mos. 1.6 mos. 0.58 <0.0001

Overall survival, median 12.3 mos. 9.9 mos. 0.64 0.0009

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SOURCE Genta Incorporated
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