Phase 2b study of pralatrexate for the treatment of advanced non-small cell lung cancer (NSCLC)

Allos Therapeutics announced the completion of patient enrollment in their Phase 2b trial comparing pralatrexate to Tarceva (erlotinib, from Genentech) in patients with advanced non-small cell lung cancer (NSCLC) who are, or have been, cigarette smokers who have failed treatment with at least one prior platinum-based chemotherapy regimen. This study is a randomized, open-label, international, multi-center trial comparing the efficacy of pralatrexate to that of Tarceva in 201 patients with Stage IIIB/IV NSCLC, including subsets of light and heavy smokers, as well as current and former smokers. Per the study protocol, the primary endpoint is overall survival. Response rate, progression-free survival and the safety and tolerability of pralatrexate will also be assessed. Patients were randomized 1:1 to receive either pralatrexate or erlotinib. Patients randomized to the pralatrexate arm received pralatrexate as an intravenous (IV) push administered on days 1 and 15 of a 28-day cycle. The initial dose of pralatrexate was 190 mg/m2. Patients randomized to the erlotinib arm received erlotinib 150 mg/day orally in a 28-day cycle. Patients in both arms received concurrent vitamin therapy of B12 and folic acid. The primary survival analysis will be performed when a pre-specified number of events have occurred in all randomized patients.

Pralatrexate is a targeted antifolate designed to accumulate preferentially in cells expressing RFC-1, a protein that is over-expressed on certain cancer cells. Once inside cancer cells, pralatrexate is efficiently polyglutamylated so that is essentially “trapped” inside cancer cells, making it less susceptible to efflux-based drug resistance.

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