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Roche Pharmaceuticals

Avastin(R) Gives an Additional 4 Months of Life to Patients With one of the Most Common Types of Lung Cancer

Basel, Switzerland, November 13 (ots/PRNewswire)

- Phase III Trial Shows Patients With Advanced Adenocarcinoma of
the Lung  Have a 45% Better Chance of Survival With Avastin
Roche announced today 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 4 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% 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%) with non-squamous NSCLC are
eligible for Avastin-based therapy.(1) 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. (2,3)
About E4599
The results of the randomised, controlled, multicentre phase III
E4599 study of 878 patients with locally advanced, metastatic or
recurrent NSCLC, with histology other than predominant squamous cell,
show that median survival of patients treated with Avastin at a dose
of 15 mg/kg every three weeks plus paclitaxel and carboplatin
chemotherapy was 12.3 months, compared to 10.3 months for patients
treated with chemotherapy alone. Patients receiving Avastin in
combination with paclitaxel and carboplatin had a 25% improvement in
overall survival compared to patients who received chemotherapy
alone. An analysis of patients with the most common type of NSCLC,
adenocarcinoma showed that the benefit was of even greater magnitude
in this particular sub-group of patients - 14.2 months of overall
survival when Avastin was used in conjunction with chemotherapy
versus 10.3 months in patients who received chemotherapy alone. In
the E4599 study, adenocarcinoma patients represented 69% of the total
study group. The majority (approx 79%) of non-squamous NSCLC patients
are eligible for Avastin-based therapy.(1) The safety profile of
Avastin in combination with chemotherapy reported in this trial was
consistent with that reported in other clinical trials in other solid
tumours. The most common adverse events associated with Avastin
therapy were: hypertension (5.6%), proteinuria (4.2%), fatigue (5.1%)
and dyspnoea (5.6%).(2) Pulmonary haemorrhage/ haemoptysis cases
(grade 3-5) have been observed in up to 2.3% of the patients treated
with Avastin plus chemotherapy as compared with < 1% with
chemotherapy alone.
Additional information http://www.Roche.com
    References
    (1). Market Research - Synovate Cancer Therapy Monitor, Top 5 EU (MAT Q4
    2006)
    (2). Sandler A, et al. Paclitaxel-Carboplatin Alone or with Bevacizumab
     for Non-Small-Cell Lung Cancer. NEJM. 2006:355; 2542-50
    (3). Manegold, C et al. BO17704 (AVAIL): A phase III randomised study of
    first-line bevacizumab combined with cisplatin/gemcitabine (CG) in
    patients with advanced or recurrent non-squamous, non-small cell lung
    cancer (NSCLC). ESMO 2008

Contact:

For more 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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