Genta unveils long-term Genasense trial data

USA-based biopharmaceutical company Genta says that data from a Phase III trial of its anticancer agent Genasense (oblimersen sodium), used as a treatment for advanced melanoma, are consistent with trends observed in earlier analyses. The company added that the long-term follow-up results form the basis for a Marketing Authorization Application currently under review by the European Medicines Agency (EMEA).

Genta said that the trial, which was conducted at 139 sites in nine countries, enrolled 771 patients with advanced forms of the disease. Participants were initially stratified on the basis of their level of the enzyme lactate dehydrogenase, which previous trials have linked to poor treatment outcome. They were then randomized to receive Genasense plus dacarbazine-based chemotherapy or chemotherapy alone.

The results of the 24-month study showed that combined Genasense and DTCI produced an overall response rate of 13.5%, versus 7.5% in the chemotherapy-alone group. The company added that, when LDH levels were taken into account, overall response rate in the combination arm was 17.2%, compared with 9.3% in the group who received dacarbazine treatment.