Roche announced that an exploratory analysis of the pivotal phase-III E4599 study demonstrated that Avastin (bevacizumab) in combination with paclitaxel and carboplatin chemotherapy led to an increase in overall survival of four months over chemotherapy alone in patients with advanced adenocarcinoma, the most common form of non-small cell lung cancer (NSCLC). Avastin gives these patients a 45 per cent better chance of survival compared to chemotherapy alone.
The E4599 study previously reported a significant increase in median overall survival in advanced NSCLC and was the first time a treatment was proven to extend overall survival beyond one year in these difficult to treat patients. This new analysis looked at different histologic sub-groups of non-squamous NSCLC patients and assessed the benefits seen with Avastin. The analysis demonstrated that patients with adenocarcinoma achieved a median overall survival of 14.2 months when treated with an Avastin-based therapy compared to 10.3 months seen with chemotherapy alone.
This is the first time a benefit of this magnitude, an overall survival beyond 14 months, has been reported in patients with adenocarcinoma.
"Earlier results from E4599 showed that bevacizumab in combination with chemotherapy significantly increased overall survival in patients with non-squamous non-small cell lung cancer," said Alan Sandler, associate professor of Medicine, medical director and thoracic oncology director at Vanderbilt-Ingram Cancer Centre and lead investigator of the E4599 study. "This additional analysis further defines the magnitude of benefit for patients with the most common type of NSCLC, adenocarcinoma."
Data from the E4599 and AVAiL studies formed the basis of Avastin's European approval in lung cancer in August 2007. Avastin-based treatment is proven to help patients with advanced lung cancer live longer than ever before and also increase the time patients live without their cancer getting worse (progression-free survival). The majority of patients (79 per cent) with non-squamous NSCLC are eligible for Avastin-based therapy. Safety of Avastin in advanced NSCLC has been confirmed in data from these two phase-III trials and show that Avastin-specific side effects are limited and manageable compared to those of chemotherapy.