Study Confirms That Avastin Significantly Increases Chance of …

BASEL, May 31 /PRNewswire-AsiaNet/ –

– Data From Pivotal Phase III AVADO Study Presented at ASCO for
the First Time

Avastin (bevacizumab), significantly improves the time patients with
metastatic breast cancer live without their disease getting worse
("progression-free survival") when combined with a commonly used chemotherapy
called docetaxel (Taxotere), compared with docetaxel alone. These findings
were presented for the first time today at the American Society of Clinical
Oncology (ASCO) meeting in Chicago. This is the second large phase III trial
that met its primary endpoint by showing that Avastin provides a significant
improvement in progression-free survival in HER 2 negative metastatic breast
cancer patients. This follows the recently published landmark E2100 study
(Avastin plus paclitaxel versus paclitaxel alone).

The results of the phase III "Avastin and Docetaxel" ("AVADO", BO17708)
study showed that the combination of Avastin and docetaxel resulted in:

– Up to a 64% increase in a patient’s chance of being alive without
disease progression compared to docetaxel alone.

– Up to two thirds of patients (63%) experiencing major shrinkage of
their tumor, which is unprecedented.

– No new safety signals related to Avastin. Furthermore, Avastin did
not have a major impact on the known toxicity profile of docetaxel.

Principal investigator for AVADO, Dr David Miles, medical oncologist,
Mount Vernon Hospital, UK said: "This is the second large phase III study to
confirm that Avastin extends the time in which patients live without disease
progression in combination with a widely used chemotherapy agent. Importantly
this study has confirmed that Avastin can be used with taxane-based
chemotherapy to provide a meaningful benefit for patients with metastatic
breast cancer."

Two doses of Avastin were investigated in the study (7.5 and 15 mg/kg
given every three weeks). The AVADO study was not powered to detect a
difference in efficacy between the two doses, however, there was a numerical
advantage for efficacy parameters in favor of the 15 mg/kg dose arm. These
results, and those of the other landmark study (E2100), support use of this
dose (5mg/kg/week). Overall survival data are still immature at present and
are expected in 2009.

This second large phase III trial follows the recently published E2100
study. Results from E2100 formed the basis of European Commission approval
and FDA accelerated approval of Avastin in combination with the widely used
chemotherapy paclitaxel for the first-line treatment of metastatic (HER-2
negative) breast cancer in March 2007 and February 2008 respectively. Study
E2100 showed that the addition of Avastin to paclitaxel doubled patients’
chance of being alive without disease progression compared to paclitaxel
alone.

Each year more than one million women are diagnosed with breast cancer
leading to over 400,000 deaths globally.

About the AVADO study

AVADO 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 response rate,
duration of response, time to treatment failure, overall survival, quality of
life, safety and tolerability.

Additional information

To access video clips about Avastin, in broadcast standard, free of
charge, please go to: http://www.thenewsmarket.com

For more information please contact: Roche, Christine Mage, +41-79788-8245,
Christine.mage@Roche.com; Jon Harris, Galliard Healthcare, +44-20-7663-2261,
jharris@galliardhealth.com

SOURCE: Roche