Second phase III study of Avastin in 1st line metastatic breast cancer meets its primary endpoint

Results of this trial further confirm the benefit Avastin brings to patients with breast cancer.

Roche announced today that a phase III study in metastatic breast cancer investigating Avastin (bevacizumab) in combination with docetaxel chemotherapy compared to docetaxel alone, met its primary endpoint of improving the time patients live without their disease advancing.

The findings come from the first analysis of the phase III “Avastin and Docetaxel” (“AVADO”, BO17708) study which investigated the addition of docetaxel to Avastin administered either at 7.5 or 15 mg/kg every 3 weeks. Both doses of Avastin in combination with chemotherapy showed statistically significant improvements in the time patients live without their disease advancing, as measured by progression-free survival, compared to chemotherapy alone. The study was not designed to compare the two Avastin-containing arms.

No new safety signals related to Avastin were observed in the trial.

Dr David Miles, medical oncologist, Mount Vernon Hospital, UK and principal investigator of AVADO, welcomed the news: “Each year more than one million women are diagnosed with breast cancer leading to over 400,000 deaths globally. This study confirms Avastin’s effect of prolonging the time in which patients live without their disease getting worse in combination with a widely used chemotherapy partner – this time gained is very precious.”

The efficacy and safety data of AVADO will be presented at an upcoming medical meeting.
This second positive phase III trial follows the recently published landmark E2100 study, which formed the basis of European Commission approval of Avastin in combination with paclitaxel for the 1st line treatment of metastatic breast cancer in March 2007. Study E2100 showed that the addition of Avastin to paclitaxel resulted in a doubling of progression-free survival compared to paclitaxel alone.

About the BO17708 study
BO17708 is an international phase III trial which randomized 736 patients who did not receive previous chemotherapy for their metastatic breast cancer to one of three groups:

* Avastin 7.5 mg/kg every 3 weeks in combination with docetaxel
* Avastin 15 mg/kg every 3 weeks in combination with docetaxel
* docetaxel + placebo as control arm

The primary objective of the study was to demonstrate superiority in progression-free survival of both Avastin containing treatment arms compared to the control arm. Secondary endpoints for the study included overall survival, response rate, duration of response, quality of life, safety and tolerability.

About Avastin
Data from the comprehensive Avastin cancer clinical development programme have 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) – first-line treatment in patients with advanced non-small cell lung cancer (NSCLC)
* March 2007 (EU) – first-line treatment in patients with metastatic breast cancer
* April 2007 (Japan) – treatment in patients with recurrent or advanced CRC
* August 2007 (EU) – first-line treatment in patients with advanced NSCLC
* December 2007 (EU) – first-line treatment in patients with advanced RCC
* January 2008 (EU) – first and later-line treatment in patients with metastatic CRC in combination with any chemotherapy