During its review, the data monitoring board (DMB) evaluated safety data from the study and conducted an analysis for futility. With more than half of the initially planned number of patients now enrolled, the board recommended that the trial continue to completion of full enrollment.
Agenda is a Phase III, randomized, double-blind, placebo-controlled trial that is intended to support global registration of Genasense for patients with advanced melanoma.
The study is designed to confirm certain safety and efficacy results from Genta’s prior randomized trial of Genasense combined with dacarbazine in patients identified by a biomarker who have not previously received chemotherapy. The co-primary endpoints of Agenda are progression-free survival and overall survival. A total of 300 patients are expected to enroll in Agenda.
Loretta Itri, president of pharmaceutical development at Genta, said: “We remain quite pleased with the high investigator enthusiasm for Agenda. We currently anticipate that accrual will complete in the first quarter of 2009.”