Avastin Approved in Europe for First-Line Treatment of Patients With Advanced Kidney Cancer

Basel (ots/PRNewswire) -

- Avastin Offers Patients the Chance to Live Twice as Long Without
Their Disease Advancing

Avastin (bevacizumab), Roche's innovative anti-cancer drug, was
approved today in Europe for the first-line treatment of patients
with advanced renal cell cancer (RCC) in combination with interferon
(IFN), the current standard of care[*]. Kidney cancer, known as renal
cell carcinoma (RCC) is a disease that kills over 100,000 people per
year world-wide.(1)

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 types.(2)

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.

"The results of the AVOREN study confirmed that Avastin is a safe,
effective and well tolerated treatment option for patients with
advanced renal cell cancer," said Professor Bernard Escudier, Head of
the Immunotherapy and Innovative Therapy Unit, Institut
Gustave-Roussy, Paris, France and Principal Investigator of the
pivotal AVOREN study. "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 are still limited"

Avastin Approval Status

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 now
kidney cancer:

- February 2004 (US) and January 2005 (EU) - first-line treatment
in patients with metastatic colorectal cancer (CRC)

- June 2006 (US) - second-line treatment in patients with
metastatic CRC

- October 2006 (US) - first-line treatment in patients with
advanced non-small cell lung cancer (NSCLC)

- March 2007 (EU) - first-line treatment in patients with
metastatic breast cancer

- April 2007 (Japan) - treatment in patients with recurrent or
advanced CRC

- August 2007 (EU) - first-line treatment in patients with
advanced NSCLC

- December 2007 (EU) - first-line treatment in patients with
advanced RCC

About the AVOREN Study

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:

- Progression free survival (PFS) was almost doubled from a median
of 5.4 to 10.2 months

- Tumour response was significantly increased from 12.8% with IFN
alone to 31.4% 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.

References

1. Parkin DM, Bray F, Ferlay J and Pisani P. 2002. CA Cancer J
Clin, 2005; 55: 74-108.

2. De Mulder, PHM. Ann Oncol, 2007; 18 (Supplement 9): ix98-ix102.

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[*] The approval is for the use of Avastin in patients with
advanced and/or metastatic RCC in combination with IFN.

ots Originaltext: Roche Pharmaceuticals
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