Early successful readout of Tarceva study in a distinct form of lung cancer

EURTAC is the first phase III study to show progression-free survival benefit of first-line Tarceva in a Western population with advanced lung cancer with EGFR mutations

Roche (SIX: RO, ROG; OTCQX: RHHBY) 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.

The European Randomised 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. "We are encouraged by these results and look forward to discussing them with health authorities around the world."

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 tumours harbour 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. Following approvals, identifying these people would give doctors the option to start Tarceva early with the aim of gaining maximum impact from its use. This approach of personalised healthcare opens up the prospect of further improving care. It is estimated that as many as one in ten (10%) lung cancer patients in the Western population and one in three (30%) Asian patients with lung cancer have NSCLC with EGFR activating mutations.1,2

Tarceva is the only EGFR inhibitor approved by both the EMA and FDA for use after first-line treatment to help keep the disease process under control (maintenance therapy) and in the second-line setting for the treatment of patients with advanced or metastatic NSCLC irrespective of EGFR mutation status. The safety and efficacy profile of Tarceva is well characterised in both maintenance and second-line settings based on data from clinical studies and use in more than 400,000 patients worldwide.

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

About the EURTAC study
EURTAC is a prospective, randomised, controlled phase III trial evaluating the first-line use of Tarceva versus platinum-based chemotherapy in patients with advanced NSCLC with EGFR activating mutations.
The primary end point is progression free survival. Secondary endpoints include overall survival; one-year survival; objective response rate and safety profile.
The platinum-based chemotherapy regimens used are cisplatin/gemcitabine; cisplatin/docetaxel; carboplatin/gemcitabine; and carboplatin/docetaxel.
About EGFR in lung cancer
EGFR is a protein that extends across the cell membrane. The epidermal growth factor (EGF) binds to the part of the EGFR protein that sits on the outside of the cell.3 Binding leads to activation of the EGFR protein which triggers a complex signalling cascade inside the cell that leads to events including accelerated cell growth and division and development of metastases (tumour growth and spread to other parts of the body).4,5 Some NSCLC tumours have activating mutations in the EGFR gene, changing the structure of the EGFR proteins such that they have increased activity.

About Tarceva
Tarceva is a once-daily, oral non-chemotherapy treatment for the treatment of advanced or metastatic NSCLC. It has been shown to potently inhibit EGFR, a protein involved in the growth and development of cancers.

Tarceva is developed and commercialized by OSI in partnership with Genentech in the United States, Chugai in Japan and Roche in the rest of the world.

About SLCG
The Spanish Lung Cancer Group is a multicenter, multidisciplinary cooperative working group. SLCG affiliates are based in 135 centres in Spain including basic researchers, thoracic surgeons, pathologists, radiotherapists and medical oncologists. SLCG is committed to independent academic research and has included more than 10,000 patients in different studies and trials. In SLCG trials translational research and customized treatment based on genetics are the main priorities.

About OSI Pharmaceuticals
OSI Pharmaceuticals is committed to "shaping medicine and changing lives" by discovering, developing and commercialising high-quality, novel and differentiated targeted medicines designed to extend life and improve the quality of life for patients with cancer and diabetes/obesity. Tarceva was discovered by a collaboration between OSI and a third party pharmaceutical company.

In June 2010, OSI Pharmaceuticals, Inc. became a wholly owned subsidiary of Astellas US Holding, Inc., which is part of the Astellas US group of companies (Astellas). For additional information about OSI, please visit http://www.osip.com.

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80'000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.