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Roche Pharmaceuticals

Large 'Real-World' Study Shows Avastin-based Therapy Extends Survival Beyond Fourteen Months in Patients With Advanced Lung Cancer

Basel, Switzerland, July 21, 2010 (ots/PRNewswire)

New data show that
Avastin(R) (bevacizumab) based therapy provides a median overall
survival (OS) of 14.6 months with a range of chemotherapies routinely
used in clinical practice and in a broad population of patients with
advanced non-small cell lung cancer (NSCLC), the most commonly
diagnosed type of lung cancer.[1] The data, published in The Lancet
Oncology,[2] are from the phase IV SAiL study of more than 2,000
patients, the vast majority of whom had adenocarcinoma, the most
common form of NSCLC.[3]
Two phase III clinical trials (E4599[3]and AVAiL[4],[5]) have
already demonstrated that first-line Avastin-based therapy
significantly improves outcomes for patients with NSCLC. The SAiL
trial data adds to this evidence base and confirms that Avastin is an
important advance for patients with NSCLC, where survival with
chemotherapy alone is typically less than one year.[6],[7] Of note,
the results observed in SAiL were consistent with those from a
preplanned analysis of the pivotal E4599 study, which showed a median
OS of 14.2 months in patients with adenocarcinoma histology.[8]
"The SAiL trial results confirm that Avastin-based therapy
represents a significant improvement in the treatment of
non-squamous, non-small cell lung cancer and with a favourable safety
profile. Extending survival beyond 14 months is truly good news for
patients diagnosed with this devastating disease, and I'm sure my
colleagues around the world will welcome these results. This
outstanding overall survival can now be achieved using Avastin
together with different chemotherapy combinations - this is really
important since it gives new treatment options where previously there
were only very few," said Professor Lucio Crino, Hospital S. Maria
della Misericordia, Perugia, Italy, lead study author.
Manageable safety profile
SAiL's broad patient population included the elderly (age greater
than  or equal to 65), those with central nervous system (CNS)
metastases and  those with poor performance status. Despite the
complexity of patients'  health at baseline, SAiL investigators
reported a low incidence of  clinically significant side effects,
confirming Avastin's well established  and manageable safety profile.
About SAiL
- A phase IV international open-label, multicentre, single-arm study
      involving 2,212 patients with untreated locally advanced, metastatic
      or recurrent non-squamous NSCLC.
    - Adenocarcinoma was the most common histological type amongst patients
      (86%).
    - The primary objective of SAiL was to confirm safety and efficacy data
      for Avastin combined with a range of standard first-line chemotherapy
      regimens, in a broad population of patients.
    - The secondary objective was to assess the efficacy of Avastin (OS,
      disease control rate [DCR] and time to progression [TTP]) and the
      safety of Avastin in patients who develop CNS metastases during and
      for six months following treatment.
    - Patients received Avastin (7.5 or 15mg/kg every 3 weeks) plus standard
      chemotherapy for up to six cycles, followed by single-agent Avastin
      maintenance until disease progression.
    - Across the total SAiL patient population, an OS of 14.6 months was
      observed together with TTP of 7.8 months, and in patients with tumour
      assessments, a DCR of 88.7% was observed.
    - SAiL demonstrated the consistent efficacy of Avastin across a wide
      range of chemotherapy regimens commonly used in clinical practice.
    - The overall rate of bleeding in SAiL was low (3.6%) and pulmonary
      haemorrhage was a rare event (0.7%). In addition, only two patients
      (0.1%) experienced clinically significant CNS bleeding among the more
      than 200 patients with CNS metastases. These findings contributed to
      those reported by a recent retrospective exploratory analysis of over
      13,000 patients from several trials of Avastin-based therapy across
      multiple cancer types, which recommended that patients with CNS
      metastases should not be generally excluded from Avastin therapy or
      clinical trials.[9]
All trademarks used or mentioned in this release are protected by
law.
About Roche
For more information: http://www.roche.com.
    References
    [1] Emilio, B. J Thorac Oncol 2007; S7-S11
    [2] Crino, L et al. Lancet Oncol; early online, July 2010.
    [3] Sandler A, et al. N Engl J Med 355: 2542-50, 2006.
    [4] Reck M, et al. J Clin Oncol 27:1227-34, 2009.
    [5] Reck M, et al. Ann Oncol 2010; early online publication February
        2010.
    [6] Earle, CC. Chest 2000; 117: 1239-46.
    [7] Schiller JH, et al. N Engl J Med; 346:92-8, 2002.
    [8] Sandler A, et al. J Thorac Oncol 2008; 3:11(Suppl. 4):S283
        (Abstract 133).
    [9] Besse et al. Clin Cancer Res 16: 269-78.

Contact:

CONTACT: For further information please contact: Federico Maiardi,
Roche,Tel: +41-61-688-7946, Mobile: +41-79-264-3978,
email:federico.maiardi@roche.com; Rosemary Hennings, Galliard,
Tel:+44-20-7663-2253, Mobile: +44-7799-411-325,
email:rhennings@galliardhealth.com

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