Genentech Inc and OSI Pharmaceuticals Inc announced the initiation of a phase IIIB clinical study of the investigational therapy Tarceva (erlotinib HCl) in patients with second- and third-line non-small cell lung cancer (NSCLC) who have previously received chemotherapy.

The clinical trial, called the ACT (Access to Care, Tarceva) trial, is a multi-centre, open-label study of once-daily oral Tarceva, with endpoints of survival and response rate.

The NDA filing is based on a pivotal Phase III double-blind, placebo-controlled trial, which included 731 patients and that compared Tarceva to placebo in the treatment of patients with advanced NSCLC after failure of at least one prior chemotherapy regimen. Detailed results of the trial were presented in June at the 40th Annual American Society of Clinical Oncology (ASCO) meeting in New Orleans, a company release said.

The study will enrol a patient population consistent with the pivotal Tarceva trial, which is the basis for the New Drug Application (NDA) that was filed with the US FDA earlier this year.

Tarceva is an investigational product designed to block tumour cell growth by inhibiting the tyrosine kinase activity of the epidermal growth factor receptor (HER1/EGFR), thereby blocking the HER1/EGFR signalling pathway inside the cell. Tarceva is currently being evaluated in an extensive clinical development programme by a global alliance of Genentech, OSI Pharmaceuticals and Roche.

In July 2004, OSI filed an NDA for Tarceva with the FDA as a monotherapy for patients with advanced NSCLC after failure of at least one standard chemotherapy regimen. The FDA designated Tarceva Pilot 1 status under its Pilot 1 Programme for Continuous Marketing Applications, a new programme designed for investigational products that have been granted Fast Track status such as Tarceva, and that have demonstrated significant promise in clinical trials as a therapeutic advance over available therapy for a disease or condition. Tarceva is the first and only targeted therapy to demonstrate an improvement in survival for advanced NSCLC patients.