Genentech and Roche announced that an interim analysis of a Phase III study of Avastin plus paclitaxel and carboplatin chemotherapies in first-line non-squamous, non-small cell lung cancer…
…met its primary efficacy endpoint of improving overall survival, or a reduction in the risk of death, compared to chemotherapy alone. The trial was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, under a Cooperative Research and Development Agreement between NCI and Genentech, Inc., and conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG). According to ECOG, data from this study will be submitted to the annual meeting of the American Society of Clinical Oncology (ASCO), May 13 – 17, 2005.
“These results represent the first study combining a targeted biologic therapy with chemotherapy to show an overall survival improvement in the first-line non-small cell lung cancer setting, and 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. “We would like to thank our collaborators at NCI and ECOG for their work on this study, as well as the many patients and their families who made the decision to participate in this study. We plan to share these data with the FDA to discuss the possibility of filing a supplemental Biologics License Application for Avastin plus chemotherapy in first-line non-small cell lung cancer.”
This is the first Phase III study to evaluate the therapeutic antibody Avastin in combination with chemotherapy in NSCLC. This was a randomized, controlled, multicenter trial that enrolled 878 patients with previously- untreated advanced NSCLC. The patients enrolled in this trial were randomized to receive treatment with paclitaxel and carboplatin chemotherapies with or without Avastin.
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