Genta Incorporated (OTCBB: GETA) today announced top-line 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 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.
AGENDA did not show a statistically significant benefit for its co-primary endpoint of progression-free survival. Secondary endpoints of overall response rate and disease control rate (which includes complete and partial responses, plus stable disease ≥ 3 months duration) also did not show a statistically significant benefit. According to the prespecified analysis plan, the statistical significance of durable response – a secondary endpoint that measures the proportion of patients who achieved a complete or partial response that lasts ≥ 6 months – is too early to evaluate. The observed differences in progression-free survival, overall response, disease control and durable response all numerically favored the group that received Genasense®.
Overall survival – the other co-primary endpoint in AGENDA – is too early to evaluate, as prospectively specified. An analysis for futility, which was defined as ≥ 50% conditional power to observe a statistically significant benefit of Genasense under the prospectively assumed hazard ratio of 0.69, has been conducted for the co-primary endpoint of overall survival. AGENDA has passed this futility analysis. The prospectively specified analyses for both overall survival and durable response will be conducted when the data are mature. The safety profile of Genasense in AGENDA was consistent with prior studies.
Quantitative details of the today’s announced results will be presented at the international conference, “Molecular Targets and Cancer Therapeutics”, that will be held November 15-19, 2009 in Boston, MA. The AGENDA results will be featured in an oral session on Monday November 15, 2009 at 5:00 PM ET. 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)
“At this time, we cannot predict whether more mature data will reveal a benefit in either overall survival or durable response,” said Dr. Raymond P. Warrell., Jr., Genta’s Chief Executive Officer. “However, the immediate failure to confirm a significant improvement in progression-free survival will preclude our submission of a regulatory application this year. Management and the Board are currently assessing the impact of these data on the Company’s strategic direction. The Company plans to provide further updates in the near future. Genta is very grateful for the tireless dedication of our employees and for the contributions of the many physicians, patients, and families who have worked to advance Genasense for the treatment of melanoma.”