Second Phase III Study Of Avastin(R) (Bevacizumab) In 1st Line Metastatic Breast Cancer Meets Its Primary Endpoint

Main Category: Breast Cancer
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 14 Feb 2008 - 1:00 PDT

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Roche announced 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 bevacizumab administered either at 7.5 or 15 mg/kg every 3 weeks. Both doses of bevacizumab in combination with chemotherapy showed statistically significant improvements in the time patients live without their disease advancing, as measured by progression-free survival (PFS), compared to chemotherapy alone. The study was not designed to compare the two bevacizumab-containing arms.

No new safety signals related to bevacizumab were observed in the trial. Avastin has a good tolerability profile and the most frequently observed drug reactions in clinical trials with bevacizumab were hypertension and proteinuria .

Dr David Miles, medical oncologist, Mount Vernon Hospital, UK and principal investigator of AVADO, welcomed the news: "Each year more than 44,000 women are diagnosed with breast cancer leading to over 12,000 deaths in the UK. 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 bevacizumab in combination with paclitaxel for the 1st line treatment of metastatic breast cancer in March 2007. Study E2100 showed that the addition of bevacizumab to paclitaxel resulted in an almost 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 bevacizumab (Avastin)

Bevacizumab is the first licensed treatment that inhibits angiogenesis - the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. It targets a naturally occurring protein called VEGF (Vascular Endothelial Growth Factor), a key mediator of angiogenesis, thus choking off the blood supply that is essential for the growth of the tumour and its spread throughout the body (metastasis).

Bevacizumab has now demonstrated a progression-free and/or overall survival benefit for patients in four types of metastatic/advanced cancer: colorectal, breast cancer, lung and renal cell cancer.

Roche and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in various tumour types (including colorectal, breast, lung, pancreatic cancer, ovarian cancer, renal cell carcinoma and others) and different settings (advanced and adjuvant ie post-operation). The total development programme is expected to include over 40,000 patients worldwide.

About Roche in the UK

Roche aims to improve people's health and quality of life with innovative products and services for the early detection, prevention, diagnosis and treatment of disease. Part of one of the world's leading healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. Globally Roche is the leader in diagnostics, and a major supplier of medicines for the treatment of cancer, transplantation, virology, bone and rheumatology, obesity and renal anaemia.

http://www.rocheuk.com

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