Roche announced 12th March the topline results of a phase III trial led by the US Cancer and leukaemia Group B (CALGB) and sponsored by the National Cancer Institute investigating the use of Avastin (bevacizumab) in combination with docetaxel chemotherapy and prednisone in men with late stage prostate cancer (hormone-refractory / HRPC).

The study, known as CALGB 90401, did not meet its primary objective of extending overall survival compared to chemotherapy and prednisone alone. A preliminary assessment of safety performed by CALGB has shown adverse events that have been previously observed in pivotal trials with Avastin. Data from the study will be submitted by CALGB for presentation at the 2010 American Society of Clinical Oncology (ASCO) annual meeting, June 4 to 8, 2010.

"Patients with hormone-refractory prostate cancer are in urgent need of new treatment options. It is unfortunate that the study did not meet its primary objective, however, we look forward to sharing the data with the medical community, including the secondary endpoints," said Hal Barron, M.D., Head Global Development and Chief Medical Officer at Roche.

These findings do not impact Avastin's approved indications, where Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment. Avastin's broad development programme in other tumour types will also continue as planned.

About CALGB 90401

CALGB 90401 is a multicentre, randomized, double-blinded, placebo-controlled phase III study designed to evaluate Avastin plus docetaxel chemotherapy and prednisone compared to docetaxel chemotherapy and prednisone alone in 1,050 men with hormone-refractory prostate cancer. The trial is sponsored by the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement between the NCI and Genentech, and conducted by a network of researchers led by the CALGB.

The primary endpoint of the study is overall survival. Secondary endpoints of the study include progression-free survival, prostate-specific antigen response rate, and safety.

Detailed safety assessments are ongoing. A preliminary assessment of safety performed by CALGB has identified severe adverse events that have been previously observed in pivotal trials with Avastin, including neutropenia and fatal infections.