Results show Genta’s cancer drug is effective

The phase III study randomly assigned 771 patients to receive standard chemotherapy using dacarbazine with or without Genasense (oblimersen).

Prior to randomization, patients were stratified on the basis of performance status, sites of metastatic disease, and baseline levels of serum lactate dehydrogenase (LDH). Previous studies have shown elevation of LDH to be a powerful predictor of poor outcome in patients with advanced melanoma.

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 that has been submitted to the European Medicines Agency (EMEA). An earlier analysis of this trial based on a minimum follow up of six months comprised the basis of a new drug application in the US that was withdrawn by Genta in 2004.