Early success of Roche drug vs lung cancer cited

SWITZERLAND — Roche announced this week that an independent data monitoring committee has recommended that the phase III EURTAC study be stopped early because the study has met its primary endpoint.

At a planned interim analysis, it was shown that compared to platinum-based chemotherapy Roche’s drug erlotinib significantly extended the time people with newly diagnosed advanced non small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations lived without their disease getting worse (progression-free survival or PFS).

A preliminary safety analysis showed the safety profile was consistent with previous studies of erlotinib.

The European Randomized Trial of Tarceva vs Chemotherapy (EURTAC), which has been designed and sponsored by the Spanish Lung Cancer Group and conducted together with investigators from France and Italy in cooperation with Roche, is the first phase III study in a Western population with this distinct form of lung cancer.

A similar study, OPTIMAL, has been carried out in an Asian population.

“The EURTAC study demonstrates that testing for EGFR activating mutations can identify people who may be candidates to receive erlotinib as their initial treatment for advanced lung cancer,” said Dr. Hal Barron, chief medical officer and head of global product development.

“We are encouraged by these results and look forward to discussing them with health authorities around the world,” Barron said.

In June 2010, Roche applied to the European Medicines Agency to extend the current label for erlotinib to include the first-line treatment of people with advanced NSCLC whose tumors harbor EGFR activating mutations.

Based on the EURTAC study data, OSI and Genentech plan to discuss similar updates to the erlotinib label with the US Food and Drug Administration.