Tarceva Phase III EURTAC study in NSCLC patients with EGFR activating mutations meets primary endpoint

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) and OSI Pharmaceuticals, a wholly owned subsidiary of Astellas U.S. Holding Inc., a holding company owned by Astellas Pharma Inc., today announced that an independent data monitoring committee has recommended that the Phase III EURTAC study be stopped early because the study met its primary endpoint. At a planned interim analysis it was shown that compared to platinum-based chemotherapy, Tarceva^® (erlotinib) significantly extended the time people with newly diagnosed advanced non-small cell lung cancer (NSCLC) with EGFR (epidermal growth factor receptor) 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 Tarceva. Data will be submitted for presentation at a future medical meeting.

“We are pleased that the EURTAC study so quickly revealed Tarceva may be a viable alternative to platinum-based chemotherapy in newly diagnosed NSCLC patients with EGFR activating mutations”

The European Randomized Trial of Tarceva vs. Chemotherapy (EURTAC), which has been designed and sponsored by the Spanish Lung Cancer Group (SLCG) 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 Tarceva as their initial treatment for advanced lung cancer," said Hal Barron, M.D., chief medical officer and head, Global Product Development, Roche. "We are encouraged by these results and look forward to discussing them with health authorities around the world."

"We are pleased that the EURTAC study so quickly revealed Tarceva may be a viable alternative to platinum-based chemotherapy in newly diagnosed NSCLC patients with EGFR activating mutations," said Naoki Okamura, chief executive officer, OSI Pharmaceuticals. "The interim analysis of the EURTAC study reinforces the role that Tarceva may have in treating patients beyond the Asian population, which has a historically higher instance of EGFR activating mutations."

In June 2010, Roche applied to the European Medicines Agency (EMA) to extend the current label for Tarceva 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 Tarceva label with the U.S. Food and Drug Administration (FDA). Roche and OSI will also collaborate regarding submissions with other health authorities. It is estimated that as many as one in 10 (10 percent) lung cancer patients in the Western population and one in three (30 percent) Asian patients with lung cancer have NSCLC with EGFR activating mutations.

Roche Molecular Systems and OSI are collaborating on the development of a PCR-based companion diagnostic test to identify people with NSCLC that harbors EGFR activating mutations.

SOURCE Genentech and OSI Pharmaceuticals