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Investor Update

Basel, 16 December 2008

Avastin filed in Europe for treatment of patients with the most aggressive form of brain cancer

Roche announced today the filing of its anti-angiogenic cancer treatment Avastin (bevacizumab) for the treatment of patients with previously treated glioblastoma, the most aggressive type of brain cancer. If granted, the new label will allow glioblastoma patients who currently have no prospects for cure and limited treatment options to benefit from the clinical advantages provided by Avastin.

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 chemotherapy.

  • 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). When Avastin was combined with irinotecan, this figure increased to 50%.   
  • In the study, nearly a third (28%) of patients responded to Avastin as a single agent, meaning tumours decreased in size by at least 50%. When Avastin was combined with irinotecan, 38% of patients responded to Avastin.
  • Patients receiving Avastin alone had a median overall survival of 9.3 months compared to 8.8 months for those receiving Avastin in combination with irinotecan, 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, Genentech have already filed in the US in November of 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 (of note it was just over 6 months = 25 weeks for historical data)
  • 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 (of note it was 15% for historical data)
  • 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 in other solid tumors. The most common severe (Grade 3 or greater) toxicities were hypertension (8.3%) and convulsion (6.0%) in the Avastin only arm; and convulsion (13.9%), neutropenia (8.9%) and fatigue (8.9%) in the Avastin + irinotecan arm . There were two deaths associated with adverse events in the Avastin-only arm and one death associated with an adverse event in the Avastin + irinotecan 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 (or glioblastoma multiforme; GBM) is the most common and most aggressive type of glioma. The prognosis for patients with GBM 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.

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 totaled 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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