Investor Update
Basel, 13 November 2008
Avastin gives an additional 4 months of life to patients with one of the most common types of lung cancer
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 (hazard ratio= 0.69; 95% CI 0.58-0.83).
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). 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.1,2
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 about 70% of the total study group. The analysis of the reminder of the tumour samples was inconclusive due primarily to small patient numbers for the different histology subtypes. 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 tumors.
About Lung Cancer
Lung cancer is the single biggest cancer killer in Europe, claiming 334,800 lives in 2006. Unfortunately, the majority of NSCLC cases are still diagnosed at an advanced stage when the cancer is inoperable or has already spread to another part of the body. In spite of the use of chemotherapy as the first-line treatment option, less than five percent of people with advanced NSCLC survive for five years after diagnosis and most die within twelve months.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at www.roche.com.
References
1.) Sandler A, et al. Paclitaxel-Carboplatin Alone or with Bevacizumab for Non-Small-Cell Lung Cancer. N Engl J Med. 2006:355; 2542-50
2.) 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
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