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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

to the placebo group (28%; p=0.0276). Overall survival improvement trends were consistently observed across subsets of patients grouped by major prognostic factors, including disease stage, performance status, and line of therapy. Positive trends were also observed on the secondary endpoints including progression-free survival (PFS) and disease control rate.

In addition to the efficacy improvements, oral talactoferrin was well tolerated in this group of patients with previously treated NSCLC. Adverse events (AEs) were generally mild, and no drug-related serious AEs were reported. There were 26% fewer AEs and 48% fewer Grade 3/4/5 AEs in the talactoferrin group relative to the placebo group (p=0.0037 and p=0.0024, respectively).

"These exciting data hold promise for the historic battle being conducted to find effective treatments for the most lethal forms of cancer," said Dr. Peter Traber, President of Baylor College of Medicine, where talactoferrin was first produced in the laboratory. "It is our sincere hope that the Phase 3 trials of talactoferrin will be successful and this drug can eventually be used globally."

About the Phase 3 NSCLC Monotherapy Study

Building on the results of the two positive Phase 2 studies, preparations are underway for Phase 3 trials with talactoferrin in two NSCLC indications: (i) first-line in combination with chemotherapy, and (ii) monotherapy in patients who have failed two or more previous therapies.

The pivotal Phase 3, multinational, randomized, double-blind, placebo- controlled monotherapy study will enroll 720 patients with Stage IIIB or IV NSCLC who have failed two or more previous therapies. Patients will receive standard supportive care and be randomly assigned (2:1) to receive single- agent treatment with either oral talactoferrin or placebo until disease progression. Overall survival will be the primary endpoint for approval. Secondary endpoints include adverse event reductions, progression
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SOURCE Agennix
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