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Genta's Genasense fails to meet co-primary endpoint of Phase III advanced melanoma trial
Friday, November 06 2009 | CommentsGenta Inc.'s investigational cancer agent Genasense (oblimersen sodium) failed to meet the co-primary endpoint of progression-free survival in a Phase III study that included patients with advanced melanoma.
The double-blind AGENDA trial included treatment-naive individuals with unresectable, progressive melanoma. All of the participants had low-normal baseline levels of the biomarker lactate dehydrogenase, a parameter associated with improved outcomes in a previous trial. The patients were randomized to receive dacarbazine plus Genasense or placebo.
Treatment with Genasense did not demonstrate statistical significance on the co-primary endpoint of progression-free survival, Genta said, adding that not enough time had passed to evaluate the other primary endpoint of overall survival. However, the company said that the study passed a futility analysis for overall survival.
The drug also failed to meet the secondary endpoints of overall response rate and disease control rate; more data are needed before durable response, also a secondary endpoint, can be assessed, the firm added.
"The prospectively specified analyses for both overall survival and durable response will be conducted when the data are mature," Genta noted.
The company could not predict whether more mature data would demonstrate a benefit in overall survival or durable response but said the findings for progression-free survival would hinder it from submitting an application for marketing approval this year.
Genta is conducting an ongoing evaluation of the AGENDA data and the data's affect on the company's strategic direction. It plans to provide more detailed study findings in Boston at next month's Molecular Targets and Cancer Therapeutics conference, which is jointly sponsored by the American Association for Cancer Research, the National Cancer Institute and the European Organisation for Research and Treatment of Cancer.
Shares of Genta closed at $0.20, down $0.46, or 70 percent, in heavy volume on the OTC Bulletin Board.
This information concerns a use that has not been approved by the Food and Drug Administration.
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