FDA Approves Bevacizumab Plus Chemotherapy to Treat NSCLC

Genentech, Inc, announced recently that the US Food and Drug Administration (FDA) has approved bevacizumab (Avastin) to be used in combination with carboplatin and paclitaxel chemotherapy for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic nonsquamous, non-small-cell lung cancer (NSCLC), the most common type of lung cancer. The approval is based on a phase III study (E4599) that showed bevacizumab in combination with chemotherapy resulted in a 25% improvement in overall survival compared to chemotherapy alone (based on a hazard ratio of 0.80).

First Therapy to Extend Survival Beyond 1 Year

"Bevacizumab, in combination with chemotherapy, is the first therapy in 10 years to improve on standard first-line treatment for advanced lung cancer and the first FDA-approved therapy ever to extend survival for these patients beyond 1 year in a large, randomized clinical study," said Alan Sandler, MD, director of Medical Thoracic Oncology at Vanderbilt-Ingram Cancer Center in Nashville, and lead investigator on the E4599 trial. "With this survival benefit, bevacizumab represents an important therapy for many advanced lung cancer patients fighting this difficult disease."

"Lung cancer is responsible for more than one-third of all US cancer deaths, killing more people than breast, prostate, colon, liver, and kidney cancers combined," said Laurie Fenton, president of the Lung Cancer Alliance in Washington, DC. "The approval of Avastin plus chemotherapy is a significant stride in the right direction, and we are pleased that Genentech continues to make lung cancer a priority."

About E4599

The FDA approval for this new indication was based on results from E4599, a randomized, controlled, multi-center trial that enrolled 878 patients with unresectable, locally advanced, recurrent or metastatic nonsquamous NSCLC. Patients with mixed histology were excluded if the predominant cell type was squamous. Results showed that patients receiving bevacizumab plus paclitaxel and carboplatin chemotherapy had a 25% improvement in overall survival, the trial's primary endpoint, compared to patients who received paclitaxel and carboplatin alone (based on a hazard ratio of 0.80). One-year survival was 51% in the bevacizumab-plus-chemotherapy arm vs 44% in the chemotherapy-alone arm. Median survival of patients treated with bevacizumab plus chemotherapy was 12.3 months, compared to 10.3 months for patients treated with chemotherapy alone.

The E4599 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. The trial was conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG).