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Roche Pharmaceuticals

Second Phase III Study of Avastin in 1st Line Metastatic Breast Cancer Meets its Primary Endpoint

Basel, Switzerland (ots/PRNewswire)

- 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:
  • first-line treatment in patients with metastatic colorectal cancer (CRC)
  • second-line treatment in patients with metastatic CRC
  • first-line treatment in patients with advanced non-small cell lung cancer (NSCLC)
  • first-line treatment in patients with metastatic breast cancer
  • treatment in patients with recurrent or advanced CRC
  • first-line treatment in patients with advanced NSCLC
  • first-line treatment in patients with advanced RCC
  • first and later-line treatment in patients with metastatic CRC in combination with any chemotherapy
All trademarks used or mentioned in this release are legally
protected.
Additional information
To access video clips about Avastin, in broadcast standard, free
of charge, please go to: http://www.thenewsmarket.com.

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