Basel, Switzerland (ots/PRNewswire) -
- 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
- 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
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.
To access video clips about Avastin, in broadcast standard, free
of charge, please go to: http://www.thenewsmarket.com.
ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.ch
For more information please contact: Roche, Christine Mage,
+41-79788-8245, Christine.mage@Roche.com; Jon Harris, Galliard
Healthcare, +44-20-7663-2261, email@example.com