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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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More unappealing Genasense news for Genta: Genta's long campaign for approval of its oncologic Genasense (oblimersen) hit another roadblock with the failure of the company's appeal of a Dec. 3, 2008 "complete response" letter. The center-level appeal failed to overturn the Office of Oncology Drug Product's conclusion that approval of the drug in chronic lymphocytic leukemia would require an additional confirmatory trial (1Pharmaceutical Approvals Monthly December 2008, In Brief). Genta has been pursuing CDER's dispute resolution process since receiving a "not approvable" letter in December 2006, contesting FDA's preference for progression-free survival over the composite endpoint used in the pivotal CLL trial. Genta made some headway in early 2008, when FDA denied the appeal but accepted complete response as an appropriate endpoint. The company proceeded to file an amended NDA with five-year follow-up data from the original Phase III trial. Genta reported that after five years, "all patients who achieved a major response (either complete or partial remission) on the Genasense treatment arm achieved superior survival compared with responders treated with chemotherapy alone." Nonetheless, "CDER concluded that new information submitted by the company in its amended [NDA] was insufficient, and the agency has recommended conducting a confirmatory clinical trial," Genta stated March 6. "While disappointed with this decision, we appreciate FDA's clarification of the path to U.S. regulatory approval." With the CLL indication stalled, Genta has been talking up use of Genasense in advanced melanoma. It expects final PFS data from the AGENDA trial in the second half of the year, with NDA submission targeted by year-end

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