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Aptosyn fails NSCLC Phase III

June 11, 2004 7:00 AM UTC

OSI (OSIP) said its Aptosyn exisulind plus Taxotere docetaxel missed the primary endpoint of improving overall survival versus Taxotere plus placebo in a Phase III trial in non-small cell lung cancer (NSCLC). Aptosyn also missed the secondary endpoints of improving one-year survival, progression-free survival and response rate.

Median survival in the double-blind trial in 610 patients with locally advanced NSCLC was 6.9 months for both treatment groups. The one-year survival rate for the Aptosyn group was 30.7%, compared with 29.5% for control. Median progression-free survival for Aptosyn and control groups was 13 weeks and 12 weeks, respectively, and the respective response rates were 9.2% and 7.2%. ...