Therapeutic Antibody 'Avastin' From Genetech Demonstrates Significant Improvement Of Cancer Survival Rates

South San Francisco, CA - Genentech, Inc. announced the publication of data from a pivotal Phase III clinical trial in the New England Journal of Medicine showing that Avastin (bevacizumab) in combination with paclitaxel and carboplatin chemotherapy significantly improved overall survival in patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC), the most common type of lung cancer. Based on this study (E4599), the U.S. Food and Drug Administration (FDA) recently approved Avastin as a first-line treatment in combination with paclitaxel and carboplatin chemotherapy for patients with this advanced form of lung cancer.

This year in the United States, the American Cancer Society estimates that lung cancer will kill more people than breast, prostate, colon, liver and kidney cancers combined, making it the leading cause of cancer death among Americans. Because most lung cancers are diagnosed during a late stage of the disease, only approximately 15 percent of patients live five years.

"This is the first large, randomized clinical study in which a targeted therapy, combined with chemotherapy, extended survival beyond one year in patients with advanced lung cancer,"said Alan B. Sandler, M.D., director of Medical Thoracic Oncology at Vanderbilt-Ingram Cancer Center in Nashville, Tenn., and study chair for the E4599 trial. "The results of this study have changed the treatment standard of care for this devastating disease an important step forward for patients with advanced lung cancer."

According to the published study, patients receiving Avastin added to a standard chemotherapy regimen of paclitaxel and carboplatin had an approximate 27 percent improvement in overall survival, the primary endpoint of the trial, compared to patients who received chemotherapy alone (based on a hazard ratio of 0.79, which can also be described as a 21 percent reduction in the risk of death). Median survival of patients treated with Avastin plus chemotherapy was 12.3 months versus 10.3 months for patients treated with chemotherapy alone. One-year survival was 51 percent for patients receiving Avastin plus chemotherapy versus 44 percent for patients who received chemotherapy alone. Two-year survival was 23 percent versus 15 percent.

The published study also showed that patients treated with Avastin plus chemotherapy experienced a 52 percent improvement in progression-free survival (based on a hazard ratio of 0.66). Median progression-free survival was 6.2 months for patients treated with Avastin plus chemotherapy, compared to 4.5 months for patients who received chemotherapy alone. The response rate as determined by study investigators was 35 percent (133/381) in the group receiving Avastin plus chemotherapy, compared to 15 percent (59/392) in the group receiving chemotherapy alone. Progression-free survival and response rate were based on investigator assessments and were not independently verified.

"The publication of this study is the result of many years of clinical research on the role of Avastin, and inhibiting blood vessel growth by specifically targeting VEGF, in the treatment of various types of cancer,"said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer. "We continue to explore the optimal use of Avastin for patients with advanced lung cancer, as well as to evaluate its potential benefits for patients with other difficult-to-treat cancers."

SOURCE: Genentech