Avastin Approved In US For First-line Treatment Of Most Common Form Of Lung Cancer

Roche announced that following yesterday's FDA approval in the US, Avastin will now benefit patients suffering from advanced non-small cell lung cancer (NSCLC)* - the most common form of this devastating disease. The approval is based on the pivotal Phase III trial data (E4599) which showed a strong survival benefit for patients treated with Avastin in combination with a platinum-based chemotherapy (carboplatin plus paclitaxel) compared to chemotherapy alone.


"Avastin is the first therapy ever to extend survival for advanced lung cancer patients beyond one year," said Eduard Holdener, Head Global Pharma Development at Roche. "The FDA approval marks a significant step forward for lung cancer patients in the US. We are committed to working with regulatory authorities around the world in order to make it available to more patients fighting this severe disease."


In the EU, Avastin in NSCLC was filed with health authorities in August this year. This application was based on the E4599 data along with preliminary data from the ongoing "Avastin in Lung" (BO17704) trial, which is exploring the combination of Avastin with another platinum-based chemotherapy (cisplatin/gemcitabine).


After colorectal and breast cancer, lung cancer is the third type of cancer in which the anti-angiogenic agent, Avastin, has demonstrated significant survival benefit. Avastin was approved in the EU in January 2005 and in the US in February 2004 for the first-line treatment of patients with metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. It received another approval in the US in June 2006 as a second-line treatment for patients with metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy. The first filing for Avastin in Japan occurred in April 2006 for the treatment of advanced colorectal cancer. More recently, Avastin was filed for the treatment of women with advanced breast cancer in the EU in July 2006.


About the E4599 study


The FDA approval is based on results from the E4599 study; a randomised, controlled, multi-centre Phase III trial. 878 patients with locally advanced, metastatic or recurrent NSCLC with histology other than predominant squamous cell were enrolled into the trial. The results showed:


Patients receiving Avastin at a dose of 15 mg/kg every three weeks plus paclitaxel and carboplatin had a 25 percent improvement in overall survival, compared to patients who received chemotherapy alone. Median survival was extended beyond one year for patients treated with Avastin (12.3 vs. 10.3 months).1 Pulmonary haemorrhage (haemoptysis) cases were observed in 2.3% of the patients receiving Avastin plus chemotherapy.















About the "Avastin in Lung" trial (BO17704)



BO17704 is a randomised, controlled, multicenter international Phase III trial which has completed enrolment with 1,043 patients with previously untreated advanced NSCLC to explore two doses of Avastin (7.5 or 15 mg/kg every 3 weeks) in combination with a platinum doublet (gemcitabine/cisplatin) chemotherapy. The primary objective of the study is to demonstrate superiority in progression-free survival of both Avastin containing treatment arms versus control. Interim data from this study was used to support the Roche filing of E4599 in Europe in August this year. The final data are expected in 2007.


About Lung Cancer


Lung cancer accounts for 1 in 3 and 1 in 4 cancer-related deaths in men and women, respectively. NSCLC is the most common form of the disease and accounts for more than 80 percent of all lung cancers, with histology other than predominant squamous cell as the most common subtype accounting for approximately 60 percent of NSCLC cases. Sadly, the majority of NSCLC cases are 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 months2.


About Avastin


Avastin is the first treatment that inhibits angiogenesis - the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called VEGF (Vascular Endothelial Growth Factor), a key mediator of angiogenesis, thus choking off the blood supply that is essential for the growth of the tumour and its spread throughout the body (metastasis).


Roche and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in various tumour types (including colorectal, breast, lung, pancreatic cancer, ovarian cancer, renal cell carcinoma and others) and different settings (advanced and adjuvant ie post-operation). The total development programme is expected to include over 40,000 patients worldwide.


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 a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, while the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (roche).


Unresectable locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC).


1 Sandler AB, Gray R, Bhramer J, et al. Randomized phase II/III Trial of paclitaxel (P) plus carboplatin (C) with or without bevacizumab (NSC # 704865) in patients with advanced non-squamous non-small cell lung cancer (NSCLC): An Eastern Cooperative Oncology Group (ECOG) Trial - E4599. ASCO 2005, Abstract LBA4.


2 Wilking N and Jonsson B. A Pan-European comparison regarding patient access to cancer drugs. Karolinska Institute in collaboration with Stockholm School of Economics, Stockholm, Sweden, 2005.


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