Avastin(R) Gives an Additional 4 Months of Life to Patients With one of the Most Common Types of Lung Cancer

- Phase III Trial Shows Patients With Advanced Adenocarcinoma of the Lung Have a 45% Better Chance of Survival With Avastin

Roche announced today that an exploratory analysis of the pivotal phase III E4599 study demonstrated that Avastin (bevacizumab) in combination with paclitaxel and carboplatin chemotherapy led to an increase in overall survival of 4 months over chemotherapy alone in patients with advanced adenocarcinoma, the most common form of non-small cell lung cancer (NSCLC). Avastin gives these patients a 45% better chance of survival compared to chemotherapy alone.

The E4599 study previously reported a significant increase in median overall survival in advanced NSCLC and was the first time a treatment was proven to extend overall survival beyond one year in these difficult to treat patients. This new analysis looked at different histologic sub-groups of non-squamous NSCLC patients and assessed the benefits seen with Avastin. The analysis demonstrated that patients with adenocarcinoma achieved a median overall survival of 14.2 months when treated with an Avastin-based therapy compared to 10.3 months seen with chemotherapy alone.

This is the first time a benefit of this magnitude, an overall survival beyond 14 months, has been reported in patients with adenocarcinoma. "Earlier results from E4599 showed that bevacizumab in combination with chemotherapy significantly increased overall survival in patients with non-squamous non-small cell lung cancer," said Alan Sandler, Associate Professor of Medicine, Medical Director and Thoracic Oncology Director at Vanderbilt-Ingram Cancer Centre and lead investigator of the E4599 study.

"This additional analysis further defines the magnitude of benefit for patients with the most common type of NSCLC, adenocarcinoma." Data from the E4599 and AVAiL studies formed the basis of Avastin's

About E4599

The results of the randomised, controlled, multicentre phase III E4599 study of 878 patients with locally advanced, metastatic or recurrent NSCLC, with histology other than predominant squamous cell, show that median survival of patients treated with Avastin at a dose of 15 mg/kg every three weeks plus paclitaxel and carboplatin chemotherapy was 12.3 months, compared to 10.3 months for patients treated with chemotherapy alone. Patients receiving Avastin in combination with paclitaxel and carboplatin had a 25%

Additional information

http://www.Roche.com

References

(1). Market Research - Synovate Cancer Therapy Monitor, Top 5 EU (MAT Q4

2006)

(2). Sandler A, et al. Paclitaxel-Carboplatin Alone or with Bevacizumab

(3). Manegold, C et al. BO17704 (AVAIL): A phase III randomised study of

SOURCE: Roche

For more information: Roche, Sriranjan Chaudhuri, +41-61-687-5104, [email protected]; Galliard Healthcare, Jon Harris, +44-20-7663-2261, [email protected]

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