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: 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. ots Originaltext: Roche Pharmaceuticals Im Internet recherchierbar: Contact: CONTACT: For further information please contact: Federico Maiardi, Roche,Tel: +41-61-688-7946, Mobile: +41-79-264-3978,; Rosemary Hennings, Galliard, Tel:+44-20-7663-2253, Mobile: +44-7799-411-325,

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