BASEL, Switzerland, September 15 /PRNewswire/ --

- Final Analysis of Study Confirms Benefit of Avastin(R) for Patients With Lung Cancer

BASEL, Switzerland, September 15 /PRNewswire/ --

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 today 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 final analysis of AVAiL is due to be presented at the ESMO Presidential Symposium: Abstract No. LBA1 Abstract title: BO17704 (AVAIL): A PHASE III RANDOMISED STUDY OF FIRST-LINE BEVACIZUMAB COMBINED WITH CISPLATIN/GEMCITABINE (CG) IN PATIENTS (PTS) WITH ADVANCED OR RECURRENT NON-SQUAMOUS, NON-SMALL CELL LUNG CANCER (NSCLC) Author/Presenter: Professor Christian Manegold Date: Monday 15 September Time: 15:25 - 15:50 Venue: Auditorium A1

About AVAiL

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. In the AVAiL study patients received treatment with either Avastin at 7.5 mg/kg or 15 mg/kg + cisplatin-gemcitabine or placebo + cisplatin-gemcitabine.

The primary objective of the study was to demonstrate superiority in progression-free survival of both Avastin containing treatment arms versus gemcitabine-cisplatin chemotherapy alone.

The results of the AVAiL trial showed that by adding Avastin to a cisplatin/gemcitabine regimen patients benefited from a significant increase in the time they live without their cancer progressing over chemotherapy alone. No new safety signals were observed.

Additional information: (video clips about Avastin in broadcast standard, free of charge)

For more information please contact Roche, Sriranjan Chaudhuri, +41-61-687-5104, ; Galliard Healthcare, Jon Harris, +44-20-7663-2261, .

For more information please contact: Roche, Sriranjan Chaudhuri, +41-61-687-5104, ; Galliard Healthcare, Jon Harris, +44-20-7663-2261, .