AVAiL Study Shows Longest Survival in Patients With Advanced Non-Small Cell Lung Cancer

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

    BASEL, Switzerland, Sept. 15 /CNW/ - 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
    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 +
    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:



    http://www.thenewsmarket.com (video clips about Avastin in broadcast
standard, free of charge)

For further information:

For further information: Roche, Sriranjan Chaudhuri, +41-61-687-5104,
sriranjan.chaudhuri@Roche.com; Galliard Healthcare, Jon Harris,
+44-20-7663-2261, jharris@galliardhealth.com

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