Phase 3 Trial of Genasense in Advanced Melanoma Does Not Show Significant Increase in Overall Survival

Genta Incorporated

today announced that overall survival for patients treated with Genasense Injection plus chemotherapy in AGENDA, the Company's Phase 3 trial of Genasense® in patients with advanced melanoma, was not significantly superior compared with patients treated with chemotherapy alone. AGENDA was a randomized, double-blind, placebo-controlled trial of dacarbazine administered with or without Genasense® in patients who had not previously received chemotherapy. As defined in a prior randomized trial, AGENDA employed a biomarker to define patients who might maximally benefit from such treatment. In the trial, median survival was 13.5 months in the Genasense group® and 13.1 months in the chemotherapy-only group (P=0.73). The durable response rate (i.e., the proportion of patients who achieved a major objective response that persists at least 6 months) was 10.8% and 7.6%, respectively (P=0.32). The safety profile of Genasense® in AGENDA was consistent with prior studies, as previously released.