Media Release

Basel, 03 June 2011

Tarceva nearly doubled the time people with a genetically distinct type of lung cancer lived without their disease getting worse

Roche (SIX: RO, ROG; OTCQX: RHHBY) 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 with 5.2 months). Tarceva significantly reduced the risk of the disease getting worse by 63 percent compared with standard chemotherapy (hazard ratio=0.37, p<0.0001). The safety profile for Tarceva was consistent with previous studies in NSCLC. These new data are being presented at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO) taking place in Chicago, June 3 to 7, 2011. 1

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.2 Similar results were observed in another Phase III trial (OPTIMAL) conducted in Asian patients with this form of NSCLC. 3

“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. “This is an important step forward in our goal of providing personalised options for people with advanced lung cancer.”

Roche has applied to the European Medicines Agency (EMA) to extend the current EU label for Tarceva to include first-line use in people with advanced EGFR activating mutation-positive NSCLC. Discussions are ongoing with the U.S. Food and Drug Administration (FDA) regarding a submission that will include the use of a companion diagnostic test to help identify patients with activating EGFR mutations who are appropriate candidates for Tarceva.

Tarceva is a proven and well established treatment for advanced lung cancer following platinum-based chemotherapy. It is the only EGFR inhibitor approved by both the EMA and U.S. FDA in people with advanced or metastatic NSCLC, irrespective of EGFR mutation status, for use immediately after initial (first-line) chemotherapy treatment to help keep the disease process under control (maintenance therapy) and in people whose disease has progressed following at least one course of chemotherapy (second- or third-line). The safety and efficacy profile of Tarceva is well characterised based on data from clinical studies and use in more than 400,000 patients worldwide.

About the EURTAC Study

  • EURTAC (European Randomised Trial of Tarceva vs. Chemotherapy) was designed and sponsored by the Spanish Lung Cancer Group (SLCG) and conducted together with investigators from France and Italy in cooperation with Roche.
  • From February 2007 to January 2011, 1,275 patients were screened for EGFR activating mutations and 174 patients were randomly assigned to receive Tarceva or platinum-based chemotherapy. The primary endpoint was investigator-assessed PFS. Secondary endpoints included response, overall survival (OS) and toxicity profiles.
  • The trial was stopped at a pre-planned interim analysis because the study met its primary endpoint.
  • Updated data showed that Tarceva nearly doubled median PFS compared with platinum-based chemotherapy (9.7 months compared with 5.2 months respectively) and reduced the risk of lung cancer getting worse by 63 percent (hazard ratio=0.37, p<0.0001; a hazard ratio of less than one indicates a decreased risk of disease progression and a p-value of less than 0.05 indicates statistical significance).
  • The safety profile for Tarceva in the EURTAC study was consistent with previous studies of Tarceva in NSCLC.

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.4 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).5,6 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 a registered trademark of OSI Pharmaceuticals, LLC, a member of the Astellas global group of companies.

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 Astellas

Astellas Pharma US, Inc., located in Deerfield, Illinois, is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. In the U.S., Astellas markets products in the areas of Anti-Infectives, Cardiology, Dermatology, Neuroscience, Transplant, Oncology and Urology. For more information about Astellas Pharma US, Inc., please visit our website at www.astellas.us or follow us on Twitter at www.Twitter.com/AstellasUS.

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 over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 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.

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References
1) Rosell R et al. ASCO 2011; Abstract 7503
2) Rosell R et al. NEJM 361; 1 – 10: 2009.
3) Zhou C et al. ESMO 2010; Abstract LBA13
4) http://www.cancer.gov/ncicancerbulletin/NCI_Cancer_Bulletin_051308/page3. Accessed 30 November 2010.
5) Prenzel N et al. Endocrine-Related Cancer 8; 11–31:2001.
6) Britten CD. Mol Cancer Ther 3; 1335-42:2004.