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Avastin(R) Shows Unprecedented Benefits in Colorectal Cancer Patients, Irrespective of K-Ras Gene Mutation
Date:6/26/2008

- For Non-US Media Only - Avastin is the Only Biologic Proven to Extend Life in Patients With

Normal K-Ras Gene

BASEL, Switzerland, June 26 /PRNewswire/ -- 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

-- 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

-- a significant increase in response rate; 60% compared to 37% in patients receiving chemotherapy alone

Significantly enhanced efficacy in patients with K-Ras mutation

-- a 69% increase in the time patients live without their disease getting worse (5.5 vs 9.4 months) vs chemotherapy alone

-- 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 tumours," 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 wild type group are impressive and confirm that Avastin should be part of the first line management of patients irrespective of K-Ras status. On a 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, tumour 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 tumour 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

Additional information

To access video clips about Avastin in broadcast standard, free of charge, please go to: http://www.thenewsmarket.com .


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SOURCE Roche
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