Mar 15 2005
Interim analysis of a Phase III study of Avastin (bevacizumab) with paclitaxel and carboplatin chemotherapies in first-line non-squamous, non-small cell lung cancer (NSCLC) met its primary goal of improving overall survival, or a reduction in the risk of death, compared to chemotherapy alone.
This is the first study to evaluate the therapeutic antibody Avastin in combination with chemotherapy in NSCLC and was a randomized, controlled, multicentre trial that involved 878 patients with previously - untreated advanced NSCLC. The patients enrolled were randomized to receive treatment with paclitaxel.
The trial, sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, under an Agreement between NCI and Genentech, Inc., was conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG) who will submit data from this study to the annual meeting of the American Society of Clinical Oncology (ASCO) in May.
Genentech, Inc. and Roche say the study, which combines a targeted biologic therapy with chemotherapy, is the first to show an overall survival improvement in the first-line non-small cell lung cancer setting, and is the first time that any treatment has improved upon the standard, two-drug chemotherapy regimen in this disease, said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer.
They are grateful to their collaborators at NCI and ECOG and to the many patients and their families who made the decision to participate in this study. They plan to share their findings with the FDA in order to discuss the possibility of filing a supplemental Biologics License Application for Avastin plus chemotherapy in first-line non-small cell lung cancer.