Genasense Ph III trial progressing on target

US drug developer Genta has reported encouraging interim data from an ongoing Phase III trial of Genasense (oblimersen sodium) Injection, its lead oncology product, in patients with advanced melanoma.

A pooled analysis of data from a late-stage study, which remains blinded, was compared with the company's previous data from a similarly designed randomized trial. The comparative analysis demonstrated that, to date, AGENDA has enrolled patients with similar demographics, and has also shown that the aggregate incidence of serious adverse events is comparable.

The randomized, double-blind, placebo-controlled trial aims to support global registration of Genasense for patients with advanced melanoma and is designed to confirm certain safety and efficacy results from Genta's prior randomized study of Genasense combined with dacarbazine in patients identified by a biomarker who have not previously received chemotherapy. The co-primary endpoints are progression-free survival and overall survival. To date, 60% of the planned 300 patients have been accrued.