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Results Show Xelox (Xeloda plus oxaliplatin) Provides Equivalent Overall Patient Survival Compared to Folfox in Advanced Colorectal Cancer

-Further Progression-Free Survival Benefit Observed with Addition of Avastin-

NUTLEY, N.J., January 22, 2007 /PRNewswire/ -- Overall survival results from an international, Phase III study (NO16966) suggest that XELOX (Xeloda(R) plus oxaliplatin) is an effective alternative to the current standard treatment, FOLFOX-4 (infused 5-FU/leucovorin plus oxaliplatin), for advanced (metastatic) colorectal cancer. In the study, XELOX -- a more convenient therapy including Roche's oral Xeloda -- provides equivalent patient survival compared to FOLFOX-4. These data were presented at the American Society of Clinical Oncology Gastrointestinal Symposium (ASCO GI) in Orlando, FL.

The Independent Review Committee (IRC) analysis also confirmed previous results indicating that the addition of Avastin to combination chemotherapy (XELOX or FOLFOX) significantly improved the chance of delaying the progression of the disease (progression-free survival, or PFS).

"These important survival results continue to affirm our initial hypothesis that XELOX is a viable, effective alternative to the current standard of care for advanced colorectal cancer," said Professor Jim Cassidy, co-lead investigator for the study and Cancer Research UK Professor of Oncology and Chair of Medical Oncology, Beatson Oncology Centre, at the University of Glasgow, Scotland. "These data underscore the tremendous promise of combinations using cornerstone therapies such as Xeloda, and the potential benefit of adding Avastin to achieve greater progression-free survival."

Additional analysis of these data is ongoing and will be presented at an upcoming international scientific meeting.

"Now, with evidence of overall survival in addition to progression-free survival, we can move closer to offering patients a convenient option of an oral component to their chemotherapy treatment," said Lars Birgerson, Vice President, Medical Affairs, Roche. "Based on these findings and results from international Phase III study (NO16967), Roche will submit a supplemental new drug application for XELOX (Xeloda plus oxaliplatin) in advanced colorectal cancer."

In 2004, colorectal cancer was one of the leading cancers and accounted for 13 percent of all cancers; it is estimated that more than 394,000 people die worldwide from colorectal cancer each year. Colorectal cancer is the third most common cancer in the United States. The American Cancer Society estimated in 2006 that more than 148,000 people in the U.S. would be diagnosed and about 55,000 people would die from the disease.

About the Study

Study NO16966 is a large, randomized, international, Phase III trial of 2,034 advanced colorectal cancer patients that initially compared first-line XELOX (Xeloda + oxaliplatin) versus FOLFOX-4 (intravenous bolus and infusional 5-fluorouracil + oxaliplatin). After release of Avastin data in colorectal cancer in 2003, the protocol was amended to investigate, using a 2 by factorial design, XELOX + placebo versus XELOX + Avastin (7.5 mg/kg q3w) versus FOLFOX-4 + placebo versus FOLFOX-4 + Avastin (5.0 mg/kg q2w).

The primary study objectives were to answer two questions: 1) whether the XELOX regimen is non-inferior to FOLFOX; 2) whether the addition of Avastin to chemotherapy improved results compared to chemotherapy alone. The secondary endpoints included overall survival, overall response rates, time to, and duration of, response and safety profile.

The results presented at ASCO GI represent only the original arm of the study, which recruited 634 patients.

About XELOX

XELOX is an abbreviation for a type of combination chemotherapy used to treat colorectal cancer; it contains Xeloda (capecitabine) plus oxaliplatin.

About XELODA (capecitabine)

Xeloda is the only FDA-approved oral chemotherapy for both metastatic breast cancer and adjuvant and metastatic colorectal cancer. Inactive in pill form, Xeloda is enzymatically activated within the body; when it comes into contact with a naturally occurring protein called thymidine phosphorylase, or TP, Xeloda is transformed into 5-FU, a cytotoxic (cell-killing) drug. Because many cancers have higher levels of TP than does normal tissue, more 5-FU is delivered to the tumor than to other tissue.

A clinically important drug interaction between Xeloda and warfarin has been demonstrated; altered coagulation parameters and/or bleeding and death have been reported. Clinically significant increases in prothrombin time (PT) and INR have been observed within days to months after starting Xeloda, and infrequently within one month of stopping Xeloda. For patients receiving both drugs concomitantly, frequent monitoring of INR or PT is recommended. Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy.

Xeloda is contraindicated in patients who have a known hypersensitivity to 5-fluorouracil, and in patients with known dihydropyrimidine dehydrogenase (DPD) deficiency. Xeloda is contraindicated in patients with severe renal impairment. For patients with moderate renal impairment, dose reduction is required.

The most common adverse events (greater than or equal to 20%) of Xeloda monotherapy were diarrhea, nausea, stomatitis and hand-foot syndrome. As with any cancer therapy, there is a risk of side effects, and these are usually manageable and reversible with dose modification or interruption.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to sell For (Selling Power), and one of AARP's Top Companies for Older Workers.

Posted: January 2007

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