Roche's innovative anti-cancer drug, Avastin (bevacizumab), was approved in Europe for the first-line treatment of patients with advanced renal cell cancer (RCC) in combination with interferon (IFN), the current standard of care1.
The approval was based on data from the pivotal phase III AVOREN trial, which showed that patients with advanced RCC who received Avastin in combination with IFN lived nearly twice as long without their disease progressing ("progression free survival"), as those who received IFN alone.
Kidney cancer, known as renal cell carcinoma (RCC) is a disease that kills over 100,000 people per year world-wide2.
There are few early symptoms in kidney cancer which means that unfortunately the majority of patients are diagnosed with advanced disease, where current treatment options are limited. Kidney cancer is highly resistant to chemotherapy and radiotherapy, which are often key weapons against other cancer types3.
"The approval by European health authorities is a significant step forward in the treatment of advanced renal cell cancer. Avastin effectively doubles the time in which patients live without their disease getting worse, so this approval has the potential to change the treatment landscape for this disease, where treatment options have been limited" said William M. Burns, CEO, Pharmaceutical Division, Roche.
Kidney cancer is the fourth cancer type in which Avastin has demonstrated positive survival benefits for patients. Data from the comprehensive Avastin cancer clinical development programme have resulted in approvals in advanced colorectal, breast, lung, and kidney cancer:
The AVOREN study is a randomised, controlled, double-blind, phase III study that included 649 patients with advanced kidney cancer from 101 study sites across 18 countries. Study participants received treatment with either Avastin and IFN alpha-2a or placebo and IFN alpha-2a, the standard of care in patients with advanced kidney cancer.
The results of the AVOREN trial showed that by adding Avastin to IFN a progression free survival (PFS) was almost doubled from a median of 5.4 to 10.2 months while the tumour response was significantly increased from 12.8 per cent with IFN alone to 31.4 per cent when Avastin was added. Dose-reduction of IFN did not appear to affect the efficacy of the combination with Avastin (based on PFS event free rates over time, as shown by a sub-group analysis). The study also showed a trend towards improved overall survival; however, these data are still pending. No new or unexpected adverse events were observed.
An interim analysis of AVOREN was performed in December 2006 and the benefits provided by Avastin were so positive that the Drug Safety Monitoring Board recommended that the trial was unblinded and all patients were offered treatment with Avastin. The study demonstrated for the first time that Avastin benefits patients in combination with an immunotherapeutic, the class of drugs to which IFN belongs.
Kidney cancer is more common in men than women (approximately 62 per cent of patients with kidney cancer are men) and incidence increases with age2.
As the most common type of kidney cancer, RCC accounts for approximately nine out of ten cases of the disease4. Within this cancer type, there are several sub-types of cancer based on looking at the cells under a microscope. Clear cell renal cell cancer is the most common type. If RCC is diagnosed at an early stage when the cancer is still confined to the kidney, the 5-year survival rates are relatively good at 60 to 75 per cent. However, if diagnosis is made at a later stage and the cancer has already spread to distant sites the 5-year survival rate is less than 5 per cent. Unfortunately, because kidney cancer is often asymptomatic, the majority of patients are diagnosed at later disease stages.
Treatment options for patients with kidney cancer are limited. Surgical removal of part or the entire kidney forms the mainstay of treatment but is only really successful in early stage disease. In later stage disease, treatment is more often employed with a view of controlling the cancer and improving associated symptoms.
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 vascular endothelial growth factor (VEGF), 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, ovarian, renal cell cancer, and others) and different settings (advanced and adjuvant i.e. post-operation). The total development programme is expected to include over 40,000 patients worldwide.
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