Genta Incorporated (OTCBB:GETA) today announced preliminary results from AGENDA, the Company’s Phase 3 trial of Genasense® (oblimersen sodium) Injection in patients with advanced melanoma. AGENDA is a randomized, double-blind, placebo-controlled trial of dacarbazine (DTIC) administered with or without Genasense® in patients who have not previously received chemotherapy. As defined in a prior randomized trial, AGENDA uses a biomarker to define patients who might maximally benefit from treatment. These results are scheduled for oral presentation today by Prof. Celeste Lebbé, Hôpital St. Louis, Paris, France at an international conference, “Molecular Targets and Cancer Therapeutics”, at 5 PM ET in Boston, MA. The “Targets Meeting” is jointly sponsored by the American Association for Cancer Research (AACR), the U.S. National Cancer Institute (NCI), and the European Organization for Research and Treatment of Cancer (EORTC).
The results do not show a statistically significant benefit for the co-primary endpoint of progression-free survival, nor for secondary endpoints of overall response or disease-control. All observed differences in currently available endpoints numerically favor the group that received Genasense®.