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Oral Talactoferrin Alfa Improves Overall Survival in Patients With Refractory Non-Small Cell Lung Cancer: Final Phase 2 Study Results Presented at the 8th Annual Targeted Therapies for the Treatment Of Lung Cancer Meeting
Date:2/26/2008

l development of talactoferrin as a single agent in patients with NSCLC who have failed two or more previous therapies. In addition, favorable Scientific Advice was received from the European Medicines Agency (EMEA) indicating that the planned single pivotal Phase 3 global trial with talactoferrin monotherapy in patients who have failed two or more previous therapies can also support a Marketing Authorization Application (MAA) in the European Union.

Final Phase 2 Study Results

The Phase 2 trial was a double-blind, placebo-controlled, single-agent study evaluating the safety and activity of oral talactoferrin monotherapy in 100 patients with stage IIIB/IV NSCLC whose cancer had progressed after previous chemotherapy. Patients received standard supportive care and were randomly assigned to receive either oral talactoferrin (1.5 g; n=47) or placebo (n=53) twice a day. Patients did not receive any other anti-cancer therapy while on the trial. Treatment was administered in 14-week cycles (12 weeks on, two weeks off) for up to three cycles or until disease progression. All 100 patients were included in the intent-to-treat (ITT) population. The 81 patients who had at least one CT scan after initiating treatment were prospectively defined as the evaluable population. The primary endpoint was overall survival in the 100-patient ITT population.

The study met its pre-specified primary endpoint - improvement in overall survival. In the 100-patient ITT population, median overall survival was 65% higher in the talactoferrin group compared to the placebo group - 6.1 months versus 3.7 months (hazard ratio=0.68; p=0.0404). In the 81-patient prospectively-defined evaluable population, the median overall survival was 80% higher in the talactoferrin group compared to the placebo group - 7.9 months versus 4.4 months (hazard ratio=0.59; p=0.0171). The six-month survival rate in the ITT population was also significantly better in the talactoferrin group (49%) compared
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SOURCE Agennix
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