Avastin benefits demonstrated in combination with a wide range of chemotherapies and in a broad patient population.

New data show that Avastin (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 (E45993and AVAiL4,5) 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 ?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

About Avastin: Over 5 Years of Transforming Cancer Care

With the initial approval in the USA for advanced colorectal cancer in 2004, Avastin became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.

Today, Avastin is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Avastin is approved in the US and Europe for the treatment of advanced stages of colorectal cancer, breast cancer, non-small cell lung cancer and kidney cancer, and Avastin is also available in the US and 24 other countries for the treatment of patients with glioblastoma (advanced brain cancer). Avastin is the only anti-angiogenic therapy available for the treatment of these numerous advanced cancer types, which collectively cause over 2.5 million deaths each year.

Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today – over three quarters of a million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 500 ongoing clinical trials is investigating the use of Avastin in over 50 tumour types (including colorectal, breast, non-small cell lung, brain, gastric, ovarian and others) and different settings (advanced or early stage disease).

About Avastin: Mode of Action

Avastin is an antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor). VEGF is the key driver of tumour angiogenesis – a fundamental process required for a tumour to grow and to spread (metastasise) to other parts of the body. Avastin’s precise mode of action allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments. Avastin helps to control tumour growth and extend survival with only a limited impact on the side effects of chemotherapy.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics and tissue-based cancer diagnostics, and is a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80,000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www. roche. com.

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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: Roche Group Media Relations, Corporate Communications, CH-4070 Basel, Switzerland, Tel: +41-61-688 8888, Fax: +41-61-688 2775, Send E-Mail

Source: Roche, F. Hoffmann-La Roche Ltd

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