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Phase III AGENDA trial probably end of the road for Genasense

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Genta is assessing the impact on its strategic direction of negative top line Phase III results for its oncologic Genasense (oblimersen), the firm announced Oct. 29. Results of the AGENDA trial of Genasense in advanced melanoma showed no statistically significant benefit in the co-primary endpoint of progression-free survival or for secondary endpoints of overall response rate and disease control rate. "At this time, we cannot predict whether more mature data will reveal a benefit in either overall survival or durable response," CEO Raymond Warrell said in a release, adding that the firm will not be submitting the application to FDA this year. The Genasense bad news has been accumulating; Genta's appeal to a December 2008 FDA "complete response" letter arguing against the agency's request for another confirmatory trial of the drug for a chronic lymphocytic leukemia indication was denied earlier this year (1Pharmaceutical Approvals Monthly March 2009). The company said it plans to provide further updates in the near future and said it 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 melanoma. Quantitative details of the AGENDA results will be presented at the Nov. 15-19 "Molecular Targets and Cancer Therapeutics" conference in Boston
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