Genentech, Astellas announce results of Tarceva Phase III study against advanced NSCLC

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) and Astellas Pharma US, Inc. ("Astellas"), today announced results of EURTAC, the first Phase III study with Tarceva® (erlotinib) in Western patients with a genetically distinct type of advanced non-small cell lung cancer (NSCLC). EURTAC showed that first-line Tarceva nearly doubled the time people with NSCLC with EGFR activating mutations lived without their disease getting worse compared with chemotherapy (median progression-free survival or PFS: 9.7 months compared to 5.2 months). Tarceva significantly reduced the risk of the disease getting worse by 63 percent compared with standard chemotherapy.

The genetically distinct type of lung cancer studied in EURTAC (epidermal growth factor receptor, or EGFR, activating mutation-positive NSCLC) occurs in approximately 10 percent of lung cancer patients in the Western population and approximately 30 percent of Asian patients. Similar results were observed in another Phase III trial (OPTIMAL) conducted in Asian patients with this form of NSCLC.

"Two studies have now shown that Tarceva as a first-line therapy for EGFR mutation-positive advanced lung cancer increased the time people lived without cancer worsening compared with standard chemotherapy," said Hal Barron, M.D., chief medical officer and head, Global Product Development, Roche. "This is an important step forward in our goal of providing personalized options for people with advanced lung cancer."

"We are pleased with the results from the EURTAC study, which is promising for patients with this genetically distinct type of NSCLC," said Steve Ryder, president of Astellas Pharma Global Development. "The data from the EURTAC study reinforces the role that Tarceva may have in NSCLC patients with a once-a-day oral pill and a known toleration profile."



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