Genta's Genasense disappoints in Ph III melanoma study

USA-based Genta (OTCBB: GNTA) received a blow yesterday, when it announced that overall survival for patients treated with Genasense (oblimersen sodium) Injection plus chemotherapy in AGENDA, the company's Phase III trial of the drug in patients with advanced melanoma, was not significantly superior compared with subjects 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 (ie, the proportion of patients who achieved a major objective response that persists at least six 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.