Avastin Shows Unprecedented Benefits in Colorectal Cancer Patients, Irrespective of K-Ras Gene Mutation

BASEL, Switzerland, June 26, 2008 /CNW/ - 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) vschemotherapy 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">http://www.thenewsmarket.com.   

For further information: Roche: Erica Bersin, +41-79-618-7672,  erica.bersin@Roche.com; Galliard Healthcare: Dominic Elliston,  +44-207-663-2266, delliston@galliardhealth.com

   

Posted: June 2008

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