Investor Update
Basel, 30 June 2008
Avastin shows unprecedented benefits in colorectal cancer patients, irrespective of K-Ras gene mutation
Avastin is the only biologic proven to extend life in patients with non-mutated K-Ras gene
Data presented today at the 10th World Congress on Gastrointestinal Cancer (WCGC) in Barcelona confirm that Avastin (bevacizumab) significantly improves survival in patients with metastatic colorectal cancer regardless of whether they have mutation in a gene known as K-Ras. This outcome is important because other biologic combinations have been found to be ineffective in patients with a mutation in the K-Ras gene, which is found in up to half of patients with colorectal cancer.
Analyses of the randomized, controlled phase III AVF2107 study, showed Avastin-based treatment resulted in:
Unprecedented efficacy in patients with normal K-Ras gene (wild type)
- a 82% increase in the time patients live without their disease getting worse (7.4 vs 13.5 months) vs chemotherapy alone (hazard ratio 0.44, p<0.0001)
- a 57% increase in overall survival (17.6 vs. 27.7 months) vs chemotherapy alone confirming that Avastin is the only biologic with proven survival benefit in this patient group (hazard ratio 0.58, p=0.04)
- a significant increase in response rate; 60% compared to 37% in patients receiving chemotherapy alone (p=0.006)
Significantly enhanced efficacy in patients with K-Ras mutations
- a 69% increase in the time patients live without their disease getting worse (5.5 vs 9.4 months) vs chemotherapy alone (hazard ratio 0.41, p=0.0008)
- these results show that Avastin-based therapy is the only biologic option with proven benefits for patients with K-Ras mutation.
"These data demonstrate that the addition of Avastin to standard chemotherapy is active for patients with metastatic colorectal cancer with both K-ras wild-type and mutant tumors,” commented Dr. Herbert Hurwitz, Duke University in Durham, North Carolina, and principal investigator of AVF2107. “The high response rate, PFS, and OS in the K-Ras WT group are impressive and confirm that Avastin should be part of the first line management of patients irrespective of K-Ras status. On practical level, K-Ras testing is not needed to initiate treatment with Avastin".
In January 2008, Avastin received a broad label in the EU allowing it to be used in combination with fluoropyrimidine-based chemotherapy for first and later treatment lines in patients with metastatic colorectal cancer. This means that virtually all patients with metastatic colorectal cancer have access to Avastin’s benefits.
About AVF2107
AVF2107 investigated the efficacy of Avastin in more than 800 previously untreated metastatic colorectal cancer patients. In the study Avastin was combined with a standard chemotherapy called irinotecan, fluorouracil and leucovorin (IFL).
The addition of Avastin to chemotherapy gave the most significant improvement in survival time ever observed in a trial of advanced colorectal cancer, significantly extending the duration of patient’s life by 30%. The results of AVF2107 formed the basis of Avastin’s first approval in February 2004 (USA) and January 2005 (EU).
In the AVF2107 analysis reported in Barcelona today, tumor tissue samples were collected in a prospective manner to analyze the efficacy of Avastin according to K-Ras status. Samples were available from 230 patients (about one third of all patients treated in the study).
About Avastin
Roche is pursuing a comprehensive clinical trial program investigating the use of Avastin in over 20 tumor types and different settings (advanced, post surgical). The total development program is expected to include over 40,000 patients world-wide and has already 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
- March 2007 (EU) – first line treatment in patients with metastatic breast cancer (BC)
- April 2007 (Japan) – treatment in patients with recurrent or advanced CRC
- December 2007 (EU) – first line treatment in patients with advanced renal cell cancer
- January 2008 (EU) – first and later line treatment in patients with metastatic CRC in combination with any chemotherapy
- February 2008 (US) - first line treatment in patients with HER-2 negative metastatic BC
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 79,000 people. Additional information is available on the Internet at www.roche.com.
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Services
Further information:
- Roche in Oncology
- Cancer
- www.avastin-info.com
- To access video clips about Avastin in broadcast standard, free of charge, please go to: www.thenewsmarket.com.