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Data Confirm Avastin(R) Helps Patients With Metastatic Colorectal Cancer Live Even Longer
Date:5/31/2008


BASEL, Switzerland, May 31 /PRNewswire/ --

- Thousands Of Patients Benefit Provided From Avastin-Based Therapy

A wealth of new Avastin (bevacizumab) data will be presented at the 44th annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago confirming that Avastin-based therapy is essential for patients with metastatic colorectal cancer (CRC). In total 15 separate data presentations will be made with highlights including:

1. Overall survival data confirmed in two large community-based studies,

including some 4,000 patients

2. First full data presentation of an Avastin and cetuximab combination

study

3. Impressive rates of curative surgery following treatment with Avastin

and chemotherapy

4. Survival benefits of Avastin confirmed with yet another chemotherapy

partner

1. Long-term overall survival reported by studies including almost 4,000 patients

The long-term benefits of Avastin use in combination with chemotherapy were confirmed by two large studies, which collectively included almost 4,000 patients with metastatic CRC. Key findings presented at ASCO from the First BEAT and BRiTE studies, which paired Avastin with chemotherapy of the investigator's choice, were:

- Avastin-based therapy provides a median overall survival benefit for patients of approximately two years (24.5 and 22.7 months from BRiTE and First BEAT respectively).

- Importantly, long-term Avastin exposure did not increase the risk of the patient suffering from Avastin-specific side effects. The incidence of Avastin-specific side effects were consistent with those reported in other scientific studies and were even less after one year of treatment.

2. Adding cetuximab to Avastin and chemotherapy decreases the time patients live without their disease getting worse

The first data presentation from the 755 patient CAIRO-2 study, which compared Avastin + chemotherapy (XELOX) versus Avastin + chemotherapy +/- cetuximab showed:

- Patients treated with Avastin and chemotherapy lived longer without their disease getting worse (progression-free survival) compared to those treated with cetuximab, Avastin and chemotherapy (median PFS = 10.7 months vs. 9.8 months).

- Patients in the cetuximab containing arm had a 10% higher incidence of serious side effects, which was mainly attributed to cetuximab-related skin toxicity.

- Both arms had comparable median overall survival benefits (20.4 months vs. 20.3 months).

3. First BEAT reports promising rates of curative surgery and strong survival outcomes

Data from the First BEAT trial shows that Avastin in combination with chemotherapy can give patients the chance to undergo surgery to potentially cure their cancer. Prior to treatment with Avastin and chemotherapy these patients were considered inoperable. The data showed:

- The overall success rate of resection surgery in patients with metastatic CRC reached an impressive 79% in the First BEAT trial.

- Out of 1,914 patients enrolled, 215 were eligible for surgery to remove their cancer that had spread (metastasized), to their liver. Of these eligible patients, 170 experienced complete removal of their liver metastases. Previously, surgery would not have been possible for these patients.

- Patients who received Avastin plus chemotherapy and underwent complete resection of their tumor had almost double the chance of surviving at 2 years compared with those who did not, at 82% versus 44%, respectively.

4. Avastin clinical benefits in metastatic CRC proven with yet another chemotherapy

Additional data presented from the AIO 0604 trial at the meeting demonstrates that Avastin is highly active and also well tolerated for CRC patients with yet further chemotherapy combinations, Xeloda (capecitabine) and irinotecan (XELIRI) and Xeloda and oxaliplatin (XELOX). This data reinforces that Avastin is first choice for the treatment of patients with CRC and that it can be used in combination with any chemotherapy partner.

Full presentation of all the data listed above will occur during ASCO:

Punt C, et al, Abstract No. LBA4011 31 May 2008, 4:45pm - 5:00pm, E

Hall D1

Berry S, et al, Abstract No. 4025, 1 June 2008, 8:00am - 12:00pm,

Poster No. 12. E450a

Cassidy J, et al, Abstract No. 4022, 1 June 2008, 8:00am - 12:00pm,

Poster No. 9. E450a

Kozloff M, et al, Abstract No. 4026, 1 June 2008, 8:00am - 12:00pm,

Poster No. 13 E450a

Reinacher-Schick AC, et al, Abstract No: 1 June 2008, 8:00am - 12:00pm,

4030, Poster No: 17 E450a

Purdie D, et al, Abstract No. 4103, 2 June 2008, 8:00am - 12:00pm, S

Poster No. 14G Hall A1

Additional information

- Roche in Oncology: http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

- Roche Health Kiosk, Cancer: http://www.health-kiosk.ch/start_krebs

- Avastin: http://www.avastin-info.com

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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