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Patients with Pancreatic Cancer Can Benefit From Avastin(R) Plus Tarceva(R)
Date:5/31/2008

- Results Confirm Previously Demonstrated Survival Advantages of Tarceva in

This Difficult-to-Treat Disease

- ABSTRACT No: 4507

BASEL, Switzerland, May 31 /PRNewswire/ -- Adding Avastin (bevacizumab) to a combination of Tarceva (erlotinib) and chemotherapy significantly improves the time patients with metastatic pancreatic cancer live without their disease getting worse ("progression free survival"). These data, presented for the first time today at the 44th annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, also showed a trend towards extending life expectancy.

Pancreatic cancer is the sixth leading cause of cancer death in Europe(1) and is extremely difficult to treat because it spreads rapidly to other parts of the body and often shows resistance to chemotherapy and radiotherapy(2). It is also difficult to diagnose, with no effective early diagnostic test available(3) so the majority of patients are diagnosed with advanced disease.

"For patients with advanced pancreatic cancer, the treatment options are limited," commented Professor Eric Van Cutsem, Professor of Medicine, Gastrointestinal Oncology Unit, University Hospital Gasthuisberg, Leuven, Belgium. "The interesting results show the need for further exploring which patients benefit from the combination of gemcitabine plus Avastin and Tarceva in view of the statistically longer PFS which trends towards improved survival."

The results of the phase III AVITA (BO17706) study showed that the addition of Avastin to a Tarceva/gemcitabine combination resulted in:

- A 37% increase in the time patients live without their disease getting

worse compared to Tarceva/gemcitabine alone

- Almost 14% of patients experiencing a complete disappearance or

shrinkage of their tumor

- A trend towards improved overall survival

- No new safety signals for Avastin

In addition, data from the Tarceva/gemcitabine control arm were consistent with previous results from the PA3 study, reinforcing the already established survival benefits of Tarceva in pancreatic cancer(4).

About AVITA

The AVITA (BO17706) study is a Roche-sponsored, randomized, double-blind, placebo-controlled phase III study that included 607 patients with metastatic pancreatic cancer. Study participants received first-line treatment with either gemcitabine, Tarceva and placebo or gemcitabine, Tarceva and Avastin (at 5mg/kg every two weeks).

The AVITA study did not meet its primary endpoint of overall survival (OS), however results showed that adding Avastin to a combination of Tarceva and chemotherapy significantly improved the time patients with pancreatic cancer lived without their disease getting worse (PFS). A trend towards improved OS was also observed.

In addition, the findings in the gemcitabine/Tarceva control arm of this trial were consistent with the efficacy observed in the metastatic patient population in the pivotal Phase III PA3 study led to the regulatory approval of Tarceva for the treatment of pancreatic cancer in the US in 2005 and in the EU in 2007.

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 .

References

(1). Michaud. Minerva Chir, 2004; 59: 99-111.

(2). Khosravi Shahi. Anales de Medicina Interna, 2005; 22: 390-4.

(3). Stewart. et al. World Health Organisation and the International

Agency for Research on Cancer, IARC Press/Lyon, 248-9.

(4). Moore et al. J Clin Oncol, 2007; 25: 1960-6.


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SOURCE Roche
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