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Investor Update

Basel, 14 November 2008

Tarceva-Avastin combination doubles time that patients with advanced lung cancer live without their disease progressing

BeTa Lung phase III data point to new chemotherapy-free treatment option in patients with advanced lung cancer

Results of the phase III BeTa Lung study investigating the addition of Avastin (bevacizumab) to Tarceva (erlotinib) for the treatment of patients with relapsed non-small cell lung cancer (NSCLC), presented today at the Multidisciplinary Symposium in Thoracic Oncology in Chicago, confirmed substantial improvements in progression-free survival (PFS) compared with Tarceva monotherapy. For the first time, a chemotherapy-free combination of Avastin and Tarceva showed the ability to increase response rates and to delay tumor progression in the second-line treatment of patients with advanced lung cancer.

Roche recently reported that the primary endpoint of the BeTa Lung study, an increase in overall survival in the second line treatment of NSCLC, was not met with median survival being similar in both arms of the study. However, the study showed that adding Avastin to Tarceva doubles the time that patients with advanced NSCLC live without their disease getting worse. Progression-free survival was 3.4 months for the Avastin/Tarceva combination versus 1.7 months for Tarceva only (hazard ratio 0.62, p<0.0001). Likewise, the objective tumour response rate more than doubled in this heavily pretreated patient population, increasing from 6.2% in the Tarceva monotherapy arm to 12.6% in the Avastin combination arm.

Analysis of subsequent lines of treatment  after disease progression showed that more patients in the Tarceva monotherapy arm received post-protocol therapies including Avastin-containing regimens than patients in the Avastin-Tarceva combination arm.  This may explain why the significant PFS benefit observed did not translate into an overall survival benefit.

No new safety signals for Avastin or Tarceva were reported, and the adverse events were similar to those observed in previous NSCLC clinical trials.

Both Avastin and Tarceva are already available for the treatment of patients with advanced NSCLC in the US and Europe. Avastin used first-line in combination with chemotherapy is proven to deliver the longest survival times for untreated patients while Tarceva as a monotherapy in second line was the first targeted therapy to significantly improve survival in previously treated patients.

The evidence of clinical activity with the combination of Avastin and Tarceva in the BeTa Lung trial is encouraging for the ongoing trials evaluating this chemotherapy-free combination in the first-line setting. A second study (ATLAS) is evaluating the combination of Avastin and Tarceva as first-line maintenance therapy for advanced lung cancer patients whose disease has not progressed following initial treatment with Avastin in combination with chemotherapy.  Results are expected in the first half of 2009.

About BeTa Lung

BeTa Lung is a multi-centre, placebo-controlled, randomised, double-blind phase III study investigating the addition of Avastin to Tarceva for the second-line treatment of patients with advanced NSCLC. A total of 636 patients were randomised to receive either 15mg/kg of Avastin every three weeks in combination with 150 mg of Tarceva daily or Tarceva alone. The primary endpoint was overall survival.  

About Lung Cancer

Lung cancer is the single biggest cancer killer in Europe, claiming 334,800 lives in 2006. Unfortunately, the majority of NSCLC cases are still diagnosed at an advanced stage when the cancer is inoperable or has already spread to another part of the body. In spite of the use of chemotherapy as the first-line treatment option, less than five percent of people with advanced NSCLC survive for five years after diagnosis and most die within twelve months.

About Avastin

Data from the comprehensive Avastin cancer clinical development programme have resulted in approvals in advanced colorectal, breast, lung, and kidney cancer:

  • February 2004 (US) and January 2005 (EU) – first-line treatment in patients with metastatic colorectal cancer (CRC)
  • June 2006 (US) – second-line treatment in patients with metastatic CRC
  • October 2006 (US) and August 2007 (EU) – first-line treatment in patients with advanced non-small cell lung cancer (NSCLC)
  • March 2007 (EU) – first-line treatment in patients with metastatic breast cancer
  • April 2007 (Japan) – treatment in patients with recurrent or advanced CRC
  • December 2007 (EU) – first-line treatment in patients with advanced RCC
  • January 2008 (EU) – first and later-line treatment in patients with mCRC in combination with any chemotherapy
  • February 2008 (US) – first-line treatment in patients with HER-2 negative metastatic breast cancer (accelerated approval)

About Tarceva

Tarceva is the first and only EGFR oral targeted agent in second line non-small cell lung cancer with a proven and significant survival and symptom benefit in a broad range of patients with advanced lung cancer without the toxic side effects of chemotherapy.  Tarceva delivers effectiveness comparable to chemotherapy and significantly improves overall quality of life. In the landmark registration study BR.21, more patients on Tarceva had improvement in cough, pain, shortness of breath and overall physical function versus patients on placebo. In addition Tarceva did not induce the distressing side-effects associated with chemotherapy, such as nausea and vomiting. Tarceva offers the convenience of an oral tablet once a day at home.

Tarceva has been approved in the European Union since September 2005 and in the US since November 2004 for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.

Furthermore, Tarceva, in combination with chemotherapy, is the first treatment in over a decade to have shown a significant survival benefit in treating patients with pancreatic cancer.  It is approved in the US, in combination with gemcitabine, for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer and in the EU for treatment of metastatic pancreatic cancer.  Since its initial launch three years ago, Tarceva has been used to treat more than 200,000 patients and has been approved in over 80 countries worldwide.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at www.roche.com.

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