Allos Therapeutics Initiates Study In Patients With Non-small Cell Lung Cancer

Allos Therapeutics initiates patient enrollment in a Phase 2b, randomized, multi-center study comparing PDX (pralatrexate) and Tarceva (erlotinib) in patients with Stage IIIB/IV 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.

"We are pleased to advance the development of PDX in solid tumors," said Pablo J. Cagnoni, M.D., Chief Medical Officer of Allos. "Advanced non-small cell lung cancer represents an area of high unmet medical need. Based on PDX's preclinical and clinical profile in non-small cell lung cancer, we believe that PDX has the potential to offer a new treatment option for patients with this challenging disease."

The objective of the Phase 2b study is to compare the efficacy of PDX to that of Tarceva. The primary endpoint of the study is overall survival (OS). Secondary endpoints include response rate and progression-free survival (PFS), both compared to Tarceva, and the safety and tolerability of PDX. The study will seek to enroll approximately 160 patients in up to 50 investigative sites worldwide. Karen Kelly, Deputy Director, The University of Kansas Cancer Center, will serve as the study chair.

In this study, patients will be randomized 1:1 to either the PDX arm or the Tarceva arm. Patients randomized to the PDX arm will receive PDX as an intravenous (IV) push administered on days 1 and 15 of a 4-week/28 day cycle. The initial dose of PDX will be 230 mg/m2, which, based on defined criteria, may be increased to 270 mg/m2 or reduced in 40 mg/m2 decrements. Patients randomized to the Tarceva arm will receive Tarceva 150 mg/day orally daily for the 4-week/28 day cycle. Patients in both arms will receive concurrent vitamin therapy of B12 and folic acid.