Aptosyn fails Phase III NSCLC trial
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Survival in OSI's Phase III study of Aptosyn (exisulind) in combination with Taxotere (docetaxel) "was essentially indistinguishable" from Taxotere plus placebo, the company reports. The advanced non-small cell lung cancer study also did not meet secondary endpoints of one-year survival, progression-free survival and response rate. OSI inherited the 610-patient study when it acquired the apoptosis technology platform from Cell Pathways in June 2003. "The lack of supporting Phase II data in advanced NSCLC made the prospects for success in the current study relatively low," the company maintains. OSI will continue to investigate the selective apoptotic anti-neoplastic drug platform "particularly in early stage and pre-cancerous conditions"...