Preliminary results from a large randomized clinical trial, sponsored by the National Cancer Institute (NCI), by a network of researchers led by the Eastern Cooperative Oncology Group. Genentech, Inc., have shown that patients with previously untreated advanced non-squamous non-small cell lung cancer who received bevacizumab (Avastin) in combination with standard chemotherapy lived longer than patients who received the same chemotherapy without bevacizumab.
Genentech, the manufacturer, provided the drug for the trial under the Cooperative Research and Development Agreement (CRADA) with NCI for the clinical development of bevacizumab.
The Data Monitoring Committee overseeing the trial (known as E4599) recommended that the results of a recent interim analysis be made public because the study had met its primary goal of improving overall survival. Researchers found that patients in the study who received bevacizumab in combination with standard chemotherapy (a treatment regimen of paclitaxel and carboplatin) had a median overall survival of 12.5 months compared to patients treated with the standard chemotherapy alone, who had a median survival of 10.2 months. This difference is statistically significant. Detailed results from this trial will be presented at the American Society of Clinical Oncology Annual Meeting (ASCO) to be held in Orlando, Fla., on May 13-17, 2005.
The results of this randomized study are exciting and reveal, for the first time, an improvement in survival with the addition of a targeted agent to standard chemotherapy in this patient population, says Study Chair Alan B. Sandler, M.D., of the Vanderbilt University Medical Centre in Nashville, Tenn.
NCI Director Andrew C. von Eschenbach, M.D.says the study demonstrates that mechanistic-based interventions such as angiogenesis inhibitors are making important contributions in improving cancer outcomes and can be used in combination with standard therapies, to treat a variety of cancers, leading to improved patient survival. The study looked at a total of 878 patients with advanced non-squamous, non-small cell lung cancer (NSCLC) who had not previously received systemic chemotherapy.
They were enrolled in the study between July 2001 and April 2004. Patients were randomized to one of the two treatment groups. One patient group received standard treatment - six cycles of paclitaxel and carboplatin. The second group received the same six-cycle chemotherapy regimen with the addition of bevacizumab, followed by bevacizumab alone until disease progression.