Roche announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the first-line use of Avastin in the treatment of the most common form of lung cancer, in combination with platinum based chemotherapy.
The CHMP's decision is based on data from the pivotal US (E4599) study and another phase III Avastin in Lung (AVAiL) study which together demonstrate that Avastin is effective in combination with a broad chemotherapy range.
Lung cancer is responsible for over 3,000 deaths per day worldwide1 and non-small cell lung cancer (NSCLC) is the most common form of the disease accounting for more than 80 per cent of all lung cancers. Avastin is the only first-line treatment in over a decade that has been shown to extend the life of patients with advanced lung cancer in a disease for which patients typically have an average life expectancy of only 8 to 10 months.
"This is a significant day for healthcare professionals and patients as it brings access to Avastin, with its proven ability to extend life in an extremely difficult to treat disease, one step closer to reality" said Professor Christian Manegold, Professor of Medicine, Heidelberg University, University Medical Center, Mannheim, Germany and Principal Investigator of the AVAiL study. "I believe that Avastin is such an innovative treatment that it will change not only the current standard of care in NSCLC, but it will also re-write our expectations for patient outcomes."
Avastin is the first and only anti-angiogenic agent which has been shown to consistently deliver improved overall and/or progression-free survival for colorectal, lung, breast, and kidney cancer patients.
"The CHMP opinion is encouraging news for European patients fighting a particularly aggressive and debilitating disease," said William M. Burns, CEO Pharmaceuticals Division of Roche. "With our Avastin development program - the biggest trial program in oncology ever - we will continue to develop the best possible treatment approaches to increase survival and improve quality of life of cancer patients."
In Europe, Avastin was approved in January 2005 and in the US in February 2004 for first-line treatment of patients with metastatic colorectal cancer. It received another approval in the US in June 2006 as a second-line treatment for patients with metastatic colorectal cancer. In October 2006, following priority review, the world's first angiogenesis inhibitor was approved by the FDA for the treatment of NSCLC). Most recently in April 2007, Avastin was approved in Europe for the first line treatment of women with metastatic breast cancer and in Japan for use in advanced or recurrent colorectal cancer.
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 chemotherapy was 12.3 months, compared to 10.3 months for patients treated with chemotherapy alone. Patients receiving Avastin at a dose of 15 mg/kg every three weeks plus paclitaxel and carboplatin had an approximate 27 percent improvement in overall survival, compared to patients who received chemotherapy alone. Side effects were generally manageable. Pulmonary haemorrhage (haemoptysis) cases were observed in 1.9% of the patients receiving Avastin plus chemotherapy. The most common adverse events associated with Avastin monotherapy were: hypertension (5.6%), proteinuria (4.2%), fatigue (5.1%) and dyspnoea (5.6%).
In the double-blind, randomised, controlled, phase III AVAiL study, patients received treatment with either Avastin at 7.5mg/kg or 15mg/kg + cisplatin/gemcitabine or placebo + cisplatin/gemcitabine. The study involved more than 1,000 patients world-wide with previously untreated advanced NSCLC, with histology other than predominant squamous cell. The results show that by adding Avastin to a cisplatin/gemcitabine regimen progression-free survival was significantly prolonged by 20 - 30% compared with chemotherapy alone. No new or unexpected adverse events were observed.
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 i.e. post-operation). The total development programme is expected to include over 40,000 patients world-wide.