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

@@start.t1@@      - 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
      - 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]@@end@@

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@@start.t2@@      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
      [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.@@end@@

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