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Investor Update

Basel, 3 November 2008

Avastin filed in U.S. for treatment of patients with the most aggressive form of brain cancer

Roche announced today that its U.S. partner Genentech submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Avastin (bevacizumab) as a therapy for patients with previously treated glioblastoma. If accepted by the FDA, the application would be considered for an accelerated approval, which allows provisional approval of medicines for cancer or other life-threatening diseases based on preliminary evidence suggesting clinical benefit.

Glioblastoma is the most aggressive type of brain cancer with no cure and few treatment options. Following initial treatment with chemotherapy and radiation, more than 90% of patients with glioblastoma will see their cancer return and there are few effective treatments when the initial therapy stops working. Median survival following progression of this cancer is typically three to six months. If licensed, Avastin therapy could make a significant difference to these patients.

The application is supported by data from the phase II BRAIN study in patients with previously treated glioblastoma that evaluated Avastin, at a dose of 10mg/kg every two weeks, as a single agent or in combination with irinotecan. When Avastin was evaluated as a single agent, the study showed that at six months almost half (43%) of patients lived without their disease advancing, as defined by progression-free survival (PFS).  In the study, nearly a third (28%) of patients responded to Avastin, meaning tumours decreased in size by at least a 50%.  Patients receiving Avastin had a median overall survival of 9.3 months, which was a secondary endpoint in the study. Most adverse events related to Avastin in this trial appeared to be similar to those previously reported in other Avastin studies1.

Based on this data Roche plans to file Avastin for a similar label in the EU later this year. Roche and Genentech plan to initiate a global phase III study in people with newly diagnosed glioblastoma in the first half of 2009 that will evaluate Avastin with standard of care chemotherapy and radiation.

About the BRAIN study

BRAIN is a non-comparative phase II, open-label, multicentre trial that randomized 167 patients with glioblastoma whose cancer had relapsed after first- or second-line therapy into one of two groups:

  • Avastin 10mg/kg every 2 weeks alone
  • Avastin 10mg/kg every 2 weeks in combination with CPT-11 (irinotecan)

All patients had received prior temozolomide therapy and radiation. Trial treatment was continued for up to 104 weeks.

The primary endpoints were six-month PFS (PFS6) and objective response rate (ORR) as determined by an independent review of patient scans. ORR was defined as a decrease in tumour size by at least 50% on two consecutive assessments at least four weeks apart. Secondary endpoints of the study included overall survival (OS) and safety.

The results of this phase II study were presented at the recent 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2008. In summary the results showed1:

  • A median OS of 9.3 months in patients treated with Avastin alone, compared with 8.8 months in the combination arm
  • Almost half of the patients in the Avastin-only arm lived without their disease advancing within six months (PFS6 42.6% vs. 50.3% in the combination arm)
  • A 28.2% ORR in the Avastin monotherapy arm (37.8% in the combination arm)

Most adverse events related to Avastin in this trial appeared to be similar to those previously reported in other studies of Avastin. The most common severe (Grade 3 or greater) toxicities in the Avastin-only arm were hypertension (8%) and convulsion (6%). There were two deaths associated with adverse events in the Avastin-only arm.

About Glioblastoma

Glioma (cancer of the glial cells) is the most common type of primary brain tumour (a tumour that originates in the brain), accounting for over half of all cases diagnosed2. Glioblastoma is the most common and most aggressive type of glioma. The prognosis for patients with glioblastoma is poor, and generally depends on the success of surgery to remove the tumour. Median survival for adults is generally less than 1 year from the initial time of diagnosis, and only about 14% of patients survive for 5 years3.

According to the National Cancer Institute, there are about 19,000 cases of primary brain tumours diagnosed every year in the U.S.

Glioblastoma is associated with high concentrations of vascular endothelial growth factor (VEGF), a protein associated with tumour growth and spread. Preclinical studies have shown a correlation between a high concentration of VEGF and a poorer prognosis in glioblastoma.

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.

References
1.Cloughesy, T, et al. A phase II, randomised, non-comparative clinical trial of the effect of bevacizumab alone or in combination with irinotecan on six-month progression-free survival in recurrent, treatment-refractory glioblastoma. Presented on Monday 2 June 2008 at ASCO; Abstract #2010b
2.Cancer research UK 2007 brain tumours http://www.cancerhelp.org.uk/help/default.asp?page=5014
3.Stupp, R, et al. Radiotherapy plus concomitant and adjuvant Temozolomide for glioblastoma. NEJM, 2005; 352: 987-96.

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