2007-06-02

Avastin(R) Significantly Prolongs Progression Free Survival in Advanced Kidney Cancer


Chicago (ots/PRNewswire) -

- Patients Have a Chance to Live Almost Twice as Long WithoutTheir Disease Returning

Adding Avastin (bevacizumab) to interferon offers patients withadvanced renal cell cancer the chance to live twice as long withouttheir disease advancing ("progression free survival") compared withinterferon alone. This is according to results from the pivotal phaseIII AVOREN trial presented today for the first time at the 43rdannual meeting of the American Society of Clinical Oncology (ASCO) inChicago.

The results of the AVOREN trial showed that by adding Avastin tointerferon, a current standard of care in advanced renal cell cancer:

- Progression free survival was almost doubled from a median of5.4 to 10.2 months

- Tumour response was significantly increased from 12.8% withinterferon alone to 31.4% when Avastin was added to the treatmentregimen

"These results are significant because there is a real need formore effective treatments in advanced kidney cancer, wherechemotherapy and radiotherapy are not as effective as in othercancers" said Professor Bernard Escudier, Head of Immunotherapy andInnovative Therapy Unit, Institut Gustave-Roussy, Paris, France andPrincipal Investigator of the study. "Avastin has been shown to beefficacious and well tolerated and is an important new treatmentoption 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 orunexpected adverse events were observed.

On an annual basis, in excess of 200,000 people worldwide willreceive a diagnosis of kidney cancer and more than 100,000 peopleworldwide will lose their lives to the disease.(i) These figures canbe expected to increase as the number of people suffering from cancerrises 50%, as recently estimated by the WHO.(ii) Roche submitted aMarketing Authorisation Application (MAA) to the European MedicinesEvaluation Agency (EMEA) based on the landmark AVOREN study in April2007.

About AVOREN

The AVOREN study is a randomised, controlled, double-blind PhaseIII study that included 649 patients from 101 study sites across 18countries. In the study patients received treatment with eitherAvastin and interferon alpha-2a or placebo and interferon alpha-2a, astandard of care in advanced kidney cancer.

The primary endpoint of the study was to demonstrate overallsurvival when Avastin was added to interferon alpha-2a therapy. Thestudy protocol specified an interim overall survival analysis beperformed at approximately 50 percent of events. Secondary endpointsincluded progression free survival (PFS), time to progression, timeto treatment failure, overall response rate and safety profile. Afinal progression-free survival analysis was specified in theStatistical Analysis Plan to occur at the time of an interim overallsurvival analysis and was presented at the ASCO 2007 conference.

The benefits of Avastin shown during the trial were so positivethat based on earlier interim results in December 2006, the DrugSafety Monitoring Board (DSMB) recommended that the trial wasunblinded and all patients were offered treatment with Avastin. Thestudy demonstrated, for the first time that Avastin also benefitspatients in combination with an immunotherapeutic.

In the US, in prior consultation with the FDA, the primaryanalysis endpoint of the AVOREN study was revised to assessimprovement in PFS, defined as the length of time the tumour did notgrow 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 withage(i,ii).

Renal cell carcinoma (RCC) is the most common type of kidneycancer, accounting for nine out of ten cases. Within this cancertype, there are several types of cancer based on looking at the cellsunder a microscope. Clear cell renal cell cancer is the most commontype. If RCC is diagnosed at an early stage when the cancer is stillconfined to the kidney, the 5 year survival rates are relatively goodat 60 - 75%. However, if diagnosis is made at a later stage and thecancer has already spread to distant sites the 5 year survival rateis less than 5%(iii). Unfortunately, because kidney cancer is oftenasymptomatic, the majority of patients are diagnosed at later diseasestages.

Treatment options for patients with kidney cancer are limited.Surgical removal of part or the entire kidney forms the mainstay oftreatment but is only really successful in early stage disease. Inlater stage disease, treatment is more often employed with a view ofcontrolling the cancer and improving associated symptoms.

About Avastin

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

Avastin has now demonstrated a progression-free and/or overallsurvival benefit for patients in four cancer types, namely:colorectal, breast, lung and renal cell cancer.

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

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world'sleading research-focused healthcare groups in the fields ofpharmaceuticals and diagnostics. As the world's biggest biotechcompany and an innovator of products and services for the earlydetection, prevention, diagnosis and treatment of diseases, the Groupcontributes on a broad range of fronts to improving people's healthand quality of life. Roche is the world leader in diagnostics anddrugs for cancer and transplantation, a market leader in virology andactive in other major therapeutic areas such as autoimmune diseases,inflammation, metabolism and central nervous system. In 2006 sales bythe Pharmaceuticals Division totalled 33.3 billion Swiss francs, andthe Diagnostics Division posted sales of 8.7 billion Swiss francs.Roche employs roughly 75,000 worldwide and has R&D agreements andstrategic alliances with numerous partners, including majorityownership interests in Genentech and Chugai. Additional informationabout the Roche Group is available on the Internet at www.roche.com.

All trademarks used or mentioned in this release are protected bylaw.

Additional information

- Roche in Oncology:www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

- 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 cancerstatistics 2002. CA Cancer J Clin 2005; 55; 74 - 108.

(ii) WHO Information sheet on cancerhttp://www.who.int/dietphysicalactivity/publications/facts/cancer/en/(accessed 24th May 2007)

(iii) Medline Pluswww.nlm.nih.gov/medlineplus/ency/article/000516.htm (accessed on 23rdOctober 2006)

ots Originaltext: Roche PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de

Contact: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)

Roche Pharmaceuticals

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Avastin(R) Significantly Prolongs Progression Free Survival in Advanced Kidney Cancer

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