The final analysis of the Avastin in lung study (AVAiL) in patients with advanced lung cancer has shown that not only did the drug significantly slow down the disease progression, it also enabled some patients to survive for over 1 year, the longest survival ever reported in patients with this advanced disease. The results were presented at the 33rd Congress of the European Society for Medical Oncology (ESMO) in Stockholm. The phase-III Roche-sponsored AVAiL study in patients with previously untreated, advanced non-small cell lung cancer (NSCLC), has confirmed that Avastin (bevacizumab) combined with gemcitabine-cisplatin chemotherapy offers a significant improvement in the time that patients live without their disease progressing (progression-free survival; PFS).

Furthermore, although the study was not designed to demonstrate an overall survival (OS) benefit, it was analysed as a secondary endpoint. The analysis showed that while the increase in overall survival was not statistically significant, the median overall survival for patients in all arms of the study exceeded 13 months - the longest survival reported in a study of patients with advanced NSCLC.

AVAiL is the second phase-III trial to demonstrate the significant clinical benefits of Avastin in NSCLC. Previously, the E4599 study, conducted in the US, showed that adding Avastin to a different platinum based chemotherapy (carboplatin-paclitaxel) resulted in a significant improvement in overall survival (its primary endpoint) compared to chemotherapy alone.

"AVAiL confirms for the second time that Avastin provides important clinical benefits and the longest survival reported for patients with advanced non squamous NSCLC," said Professor Christian Manegold, Professor of Medicine at the Heidelberg University in Mannheim, Germany and Principal Investigator of the study. "These results once again support Avastin based therapy as first-line standard of care in the vast majority of these patients with good clinical condition."

Data from the E4599 and AVAiL studies formed the basis of Avastin's European approval in lung cancer in August 2007 which meant, for the first time, patients could benefit from a treatment with proven ability to extend survival beyond one-year.

The AVAiL study is a randomised, controlled, double-blind phase-III study that included more than 1,000 patients with previously untreated advanced NSCLC, the most common form of lung cancer, with histology other than squamous cell.