CHICAGO, June 2 /PRNewswire/ --
-- Patients Have a Chance to Live Almost Twice as Long Without Their Disease Returning
Adding Avastin (bevacizumab) to interferon offers patients with advanced renal cell cancer the chance to live twice as long without their disease advancing ("progression free survival") compared with interferon alone. This is according to results from the pivotal phase III AVOREN trial presented today for the first time at the 43rd annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
The results of the AVOREN trial showed that by adding Avastin to interferon, a current standard of care in advanced renal cell cancer:
-- Progression free survival was almost doubled from a median of 5.4 to 10.2 months
-- Tumour response was significantly increased from 12.8% with interferon alone to 31.4% when Avastin was added to the treatment regimen
"These results are significant because there is a real need for more effective treatments in advanced kidney cancer, where chemotherapy and radiotherapy are not as effective as in other cancers" said Professor Bernard Escudier, Head of Immunotherapy and Innovative Therapy Unit, Institut Gustave-Roussy, Paris, France and Principal Investigator of the study. "Avastin has been shown to be efficacious and well tolerated and is an important new treatment option in the fight against this cancer"
The study also showed a trend towards improved overall survival; however, the overall survival data are still pending. No new or unexpected adverse events were observed.
On an annual basis, in excess of 200,000 people worldwide will receive a diagnosis of kidney cancer and more than 100,000 people worldwide will lose their lives to the disease.(i) These figures can be expected to increase as the number of people suffering from cancer rises 50%, as recently estimated by the WHO.(ii) Roche submitted a Marketing Authorisation Application (MAA) to the European Medicines Evaluation Agency (EMEA) based on the landmark AVOREN study in April 2007.
About AVOREN
The AVOREN study is a randomised, controlled, double-blind Phase III study that included 649 patients from 101 study sites across 18 countries. In the study patients received treatment with either Avastin and interferon alpha-2a or placebo and interferon alpha-2a, a standard of care in advanced kidney cancer.
The primary endpoint of the study was to demonstrate overall survival when Avastin was added to interferon alpha-2a therapy. The study protocol specified an interim overall survival analysis be performed at approximately 50 percent of events. Secondary endpoints included progression free survival (PFS), time to progression, time to treatment failure, overall response rate and safety profile. A final progression-free survival analysis was specified in the Statistical Analysis Plan to occur at the time of an interim overall survival analysis and was presented at the ASCO 2007 conference.
The benefits of Avastin shown during the trial were so positive that based on earlier interim results in December 2006, the Drug Safety Monitoring Board (DSMB) recommended that the trial was unblinded and all patients were offered treatment with Avastin. The study demonstrated, for the first time that Avastin also benefits patients in combination with an immunotherapeutic.
In the US, in prior consultation with the FDA, the primary analysis endpoint of the AVOREN study was revised to assess improvement in PFS, defined as the length of time the tumour did not grow or patient death did not occur.
About Kidney Cancer
Kidney cancer is more common in men than women (approximately 62% of renal cell carcinoma occurs in males) and incidence increases with age(i,ii).
Renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for nine out of ten cases. Within this cancer type, there are several 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 - 75%. 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%(iii). 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.
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).
Avastin has now demonstrated a progression-free and/or overall survival benefit for patients in four cancer types, namely: colorectal, breast, lung and renal cell cancer.
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 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 diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide 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 at www.roche.com.
All trademarks used or mentioned in this release are protected by law.
Additional information
-- Roche in Oncology: www.roche.com/pages/downloads/company/pd...
-- Roche Health Kiosk, Cancer: www.health-kiosk.ch/start_krebs
-- Avastin: www.avastin-info.com
References
(i) Parkin DM, Bray F, Ferlay J and Pisani P. Global cancer statistics 2002. CA Cancer J Clin 2005; 55; 74 - 108.
(ii) WHO Information sheet on cancer http://www.who.int/dietphysicalactivity/... (accessed 24th May 2007)
(iii) Medline Plus www.nlm.nih.gov/medlineplus/ency/article... (accessed on 23rd October 2006)
For more information please contact: Roche: Erica Bersin, +41-61-688-2164 (direct), +41-79-618-7672 (mobile on-site at ASCO); Galliard Healthcare: Jon Harris, +44-0207-663-2261 (direct)
