Analysis of Genasense(R) Trial Confirms Major Efficacy Variables in Patients with Advanced Melanoma
Multivariate Analysis Presented in Paris Defines Role of Prognostic Factors in Largest Randomized Trial
BERKELEY HEIGHTS, N.J., Feb. 2 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA) announced the presentation of analyses that confirmed the major efficacy variables from the Company's randomized Phase 3 trial of Genasense(R) (oblimersen) plus chemotherapy in patients with advanced
metastatic melanoma.
The data were presented in Paris, France at the 17th International Congress on Anticancer Treatment by Dr. Alexander Eggermont from the Daniel den Hoed Cancer Center, Erasmus University, Rotterdam, The etherlands.
Dr. Eggermont is the current president of the European
Organization on Research and Treatment of Cancer (EORTC).
Recent studies conducted by the EORTC and other groups have shown that levation of serum lactate dehydrogenase (LDH), a routine blood test, is the most powerful predictor of poor outcome in patients with advanced melanoma.
The Genasense 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.
The analysis of this trial with a minimum follow-up of 24 months on all patients comprised the basis of a Marketing Authorization Application (MAA) that has been submitted to the European Medicines Agency (EMEA).
A summary of safety and efficacy data from the MAA can be viewed at the Company's website: genta.com . An earlier analysis of this trial based on a minimum followup of 6 months comprised the basis of a New Drug Application in
the U.S. that was withdrawn by Genta in 2004.
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