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news.Genentech and Roche have reported that an interim analysis of a phase III study of Avastin plus chemotherapy, met its primary efficacy endpoint of improving overall survival in lung cancer patients, compared to chemotherapy alone.
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The trial was sponsored by the National Cancer Institute (NCI), under a cooperative R&D agreement between NCI and Genentech, and conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG).
It evaluated Avastin (bevacizumab) plus paclitaxel (Bristol-Myers Squibb’s Taxol) and carboplatin (Bristol-Myers Squibb’s Paraplatin) chemotherapies in first-line non-squamous, non-small cell lung cancer (NSCLC).
“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 Dr Hal Barron, Genentech’s senior vice president of development and chief medical officer.
Genentech now plans to share the results with the FDA and to discuss the possibility of filing a supplemental biologics license application (BLA) for Avastin plus chemotherapy in first-line NSCLC.
Genentech shares were pushed up by almost 5% in pre-market trading after the announcement was made.