Investor Update

Basel, 02 June 2014

The combination of Roche's Avastin and Tarceva helped people with a specific form of lung cancer live longer without their disease worsening

  • Phase II study in Japanese patients with a specific type of lung cancer meets primary endpoint of improved progression-free survival with the combination of Avastin and Tarceva compared to Tarceva alone

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the phase II JO25567 study in which Avastin® (bevacizumab) was added to Tarceva® (erlotinib) as initial (first-line) treatment for people with advanced non-small cell lung cancer (NSCLC) characterised by activating mutations of the epidermal growth factor receptor (EGFR Mut+). Patients who received the combination in this study lived significantly longer without their disease getting worse (progression-free survival; PFS) compared to those given Tarceva alone. The results suggest that combining Avastin and Tarceva (anti-angiogenic and EGFR mutation-directed therapies) can provide significant clinical benefit beyond that provided by Tarceva alone for patients with EGFR Mut+ NSCLC.

The current first-line standard of care for EGFR Mut+ NSCLC is monotherapy with an EGFR mutation directed tyrosine kinase inhibitor (TKI) such as Tarceva. This specific form of lung cancer accounts for 30% of lung cancers in the Asian population.1 In JO25567, Japanese patients who received first-line Avastin plus Tarceva lived a median of 6.3 months longer without their disease progressing compared to those who received Tarceva alone; a 46% reduction in the risk of disease progression or death (16.0 vs. 9.7 months; HR=0.54, p=0.0015). No new Avastin or Tarceva safety events were observed.

Results from the JO25567 study will be presented today in an oral session of the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) by Dr. Terufumi Kato, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan (Abstract 8005, June 2nd at 16:12 PM CDT, E Hall D2).

About the JO25567 study

JO25567, sponsored by Chugai, is a randomised Phase II study investigating the safety and efficacy of first-line Avastin and Tarceva compared to Tarceva alone in 154 Japanese patients with EGFR Mut+ NSCLC. The primary endpoint is progression-free survival as assessed by an independent review committee. Secondary endpoints include Overall Survival (OS), Objective Response Rate (ORR), Disease Control Rate (DCR), Response duration, Quality of Life and Safety.

  • •Japanese patients who received Avastin plus Tarceva lived a median of 6.3 months longer without their disease progressing compared to those who received Tarceva alone; a 46% reduction in the risk of disease progression or death (16.0 vs. 9.7 months; HR=0.54, p=0.0015).
  • •No new Avastin or Tarceva safety events were observed.

About Lung cancer  

Lung cancer is the leading cause of cancer death globally. It kills more people than breast, colorectal and prostate cancers combined.2 Each year 1.59 million people die as a result of the disease,2 equating to more than 4,000 deaths a day worldwide, or three deaths every minute. NSCLC accounts for 85 percent of all lung cancers.3

About EGFR Mut+ NSCLC

EGFR is a protein that extends across the cell surface. Epidermal growth factor (EGF) binds to the part of the EGFR protein that sits on the outside of the cell. 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). Some NSCLC tumours have activating mutations in the EGFR gene, changing the structure of the EGFR proteins such that they have increased activity.

About Avastin – mechanism of action

An independent blood supply is critical for a tumour to grow beyond a certain size (2mm) and spread (metastasise) to other parts of the body. Tumours develop their own blood supply in a process called angiogenesis by releasing vascular endothelial growth factor (VEGF) – a key driver for tumour growth. Avastin is an antibody that precisely targets and inhibits VEGF. Precise VEGF inhibition by Avastin allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments with limited additional impact on the side effects of these therapies.

About Tarceva

Tarceva is a once-daily, oral non-chemotherapy medicine for the treatment of advanced or metastatic NSCLC. It has been shown to potently inhibit epidermal growth factor receptor (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 group of companies. Tarceva is developed and commercialised by Astellas Pharma U.S. in partnership with Genentech in the United States, Chugai in Japan and Roche in the rest of the world.

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, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
1. Mitsudomi T et al. biological and clinical implications of EGFR mutations in lung cancer. Int J Clin Oncol 2006;11:190-8
2. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012 http://globocan.iarc.fr/Pages/fact_sheets_population.aspx Last accessed May 2014
3. Barzi A and Pennell NA. Targeting angiogenesis in non-small cell lung cancer: agents in practice and clinical development. EJCMO (2010). 2(1):31-42