Roche and Genentech have filed an sBLA for Avastin in the U.S. for the treatment of non-squamous, non-small cell lung cancer (NSCLC). The sBLA has been submitted for use of Avastin in combination with a platinum-based chemotherapy for previously untreated patients suffering from advanced NSCLC, which accounts for 87% of all lung cancers cases.
The sBLA submission is based on Genentech's results of the E4599 trial that enrolled 878 patients with locally advanced, metastatic or recurrent NSCLC with histology other than predominant squamous cell. The results showed that patients receiving Avastin at a dose of 15mg/kg every three weeks plus paclitaxel and carboplatin had a 25% improvement in overall survival. The trial's primary endpoint compared to patients who received chemotherapy alone, is equivalent to a 20% reduction in the risk of death. The survival of patients treated with Avastin plus chemotherapy was 12.3 months, compared to 10.3 months for patients treated with chemotherapy alone.
The study also showed a 54% improvement in progression-free survival, which can also be referred to as a 35% reduction in the risk of progression. The response rate in patients with measurable disease was 29% in the group receiving Avastin plus chemotherapy, compared to 13% in the group receiving chemotherapy alone. Pulmonary hemorrhage cases were observed in 2.3% of the patients receiving Avastin plus chemotherapy.