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