Hana Biosciences has reported positive interim data from an ongoing, multicenter
Phase I clinical study evaluating single agent Talotrexin (PT-523) in relapsed
or refractory advanced non-small cell lung cancer (NSCLC).
The multicenter, multinational study is an open-label, dose finding study that seeks to determine the maximum tolerated dose, dose-limiting toxicities, and obtain preliminary objective tumor response in NSCLC patients who failed at least two lines of standard chemotherapy and/or an epidermal growth factor receptor tyrosine kinase inhibitor.
Talotrexin was administered as a five minute intravenous infusion (IV) on Days 1 and 8 of a 21-day cycle with folic acid and B12 vitamin supplementation. Eligible patients with ECOG performance status of 0-2 were administered increasing doses of Talotrexin. At this interim analysis, 15 patients have received a total of 50 cycles of Talotrexin at doses of 27 mg to 270 mg per cycle. Thirteen patients had evaluable CT scans, and all evaluated have failed previous platinum therapy. Talotrexin administered on this schedule as a single agent has demonstrated acceptable tolerability with encouraging activity in patients with relapsed or refractory NSCLC.