Genentech, Inc. (NYSE: DNA) announced that a Roche-sponsored Phase III study evaluating two different doses of Avastin(R) (bevacizumab) in combination with gemcitabine and cisplatin chemotherapy met the primary endpoint of prolonging progression-free survival (PFS) in patients with previously untreated, advanced non-squamous, non-small cell lung cancer (NSCLC), the most common form of the disease.
Both doses of Avastin (15 mg/kg or 7.5 mg/kg every three weeks) significantly improved PFS compared to chemotherapy alone, as assessed by trial investigators. Although the study was not designed to compare the Avastin doses, a similar treatment effect in PFS was observed between the two arms. No new safety signals related to Avastin were observed in the study. More than 1,000 patients from outside of the United States participated in the trial, known as AVAiL (BO17704).
“In addition to supporting Avastin’s benefit in advanced lung cancer, these results demonstrate Avastin’s potential when used in combination with a different chemotherapy regimen,” said Hal Barron, M.D., Genentech’s senior vice president, Development and chief medical officer. “We will continue to analyze these data to better understand the benefit and relative safety of each arm and these findings will be presented at an upcoming medical meeting.”
Based on an improvement in overall survival, the U.S. Food and Drug Administration (FDA) in October 2006 granted a supplemental approval for Avastin in combination with carboplatin and paclitaxel for the first-line treatment of advanced NSCLC. The U.S. approval is based on results of the Phase III E4599 trial that studied a 15 mg/kg dose of Avastin administered every three weeks. The 15 mg/kg dose was selected based on the outcome of a randomized Phase II study evaluating two different doses of Avastin in combination with carboplatin and paclitaxel chemotherapy.