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www.fdanews.com/articles/84309-analysis-of-genasense-trial-confirms-major-efficacy-variables-in-patients-with-advanced-melanoma

ANALYSIS OF GENASENSE TRIAL CONFIRMS MAJOR EFFICACY VARIABLES IN PATIENTS WITH ADVANCED MELANOMA

February 3, 2006

Genta has announced results from a randomized Phase III trial of Genasense (oblimersen) plus chemotherapy in patients with advanced metastatic melanoma.

The study -- the largest randomized trial ever conducted in patients with advanced melanoma -- randomly assigned 771 patients to receive standard chemotherapy using dacarbazine with or without Genasense. Prior to randomization, patients were stratified on the basis of performance status, sites of metastatic disease, and baseline levels of LDH.

Consistent with prior studies, the multivariate analysis confirmed that each of the three stratification factors was significantly correlated with survival in the Genasense trial, whether examined alone or in a Cox multivariate model. However, LDH was the only factor that showed a statistically significant interaction with treatment. Furthermore, the analysis also showed that Genasense was significantly superior to chemotherapy alone in major efficacy variables after accounting for prognostic factors. The maximal benefit of Genasense was observed in patients without elevation in baseline LDH, a group that comprised approximately two-thirds of the study population, or more than 500 patients.