Roche study showed that Avastin helped people with newly diagnosed glioblastoma live longer without their disease worsening when

Roche study showed that Avastin helped people with newly diagnosed 
glioblastoma live longer without their disease worsening when added to 
radiation and chemotherapy 
BASEL, Switzerland, Nov. 19, 2012 /CNW/ - Roche (SIX: RO, ROG; OTCQX: RHHBY) 
today announced results from the positive phase III AVAglio study. The study 
showed Avastin(®) (bevacizumab) in combination with radiation and 
temozolomide chemotherapy reduced the risk of cancer worsening or death 
(progression-free survival; PFS) by 36 percent compared to radiation and 
temozolomide chemotherapy plus placebo (HR=0.64; p0.0001) in people with newly 
diagnosed glioblastoma, the most common and aggressive form of primary brain 
cancer. PFS assessed by trial investigators was a co-primary endpoint for the 
study. The interim results for overall survival (OS), the other co-primary 
endpoint, did not reach statistical significance (HR=0.89; p=0.2135). Final 
data on overall survival are expected in 2013. The data were presented at the 
17th Annual Meeting of the Society for Neuro-Oncology in Washington D.C., USA. 
No new safety findings were observed in the AVAglio study and adverse events 
were consistent with those seen in previous trials of Avastin across tumour 
types for approved indications. 
"People with newly diagnosed glioblastoma have few treatment options and need 
new medicines," said Hal Barron M.D., chief medical officer and head of Global 
Product Development. "An important outcome from the AVAglio study was that 
patients who received Avastin plus radiation and chemotherapylived 
significantly longer without their disease getting worse, and we plan to 
discuss these data with regulatory authorities." 
Avastin is currently approved in the United States and almost 40 countries 
worldwide for the treatment of glioblastoma as a single agent and in some 
countries in combination with irinotecan for adult patients with progressive 
disease following prior therapy (recurrent setting). The approval in the USA 
was granted under the Food and Drug Administration's (FDA) accelerated 
approval programme. 
The results of the phase III AVAglio trial were presented in Plenary Session 5 
by Professor Olivier Chinot, AVAglio Principal Investigator, President of 
Association des Neuro-Oncologue d'Expression Française (ANOEF), Head of the 
Neuro-Oncology Department, University Hospital Timone, Marseille, France 
(Abstract OT-03, Saturday 17 November, 10:45 a.m. Eastern Time). 
AVAglio study results 
Primary endpoints: 


    --  The 36 percent reduction in the risk of disease worsening or
        death can also be referred to as a 56 percent improvement in
        PFS (HR=0.64; p0.0001).
    --  A 4.4 month improvement in median PFS was observed when people
        with newly diagnosed glioblastoma received Avastin in
        combination with radiation and chemotherapy compared to those
        who received radiation and chemotherapy plus placebo (10.6
        months vs. 6.2 months, respectively, p0.0001).
    --  Interim results for overall survival did not reach statistical
        significance (HR=0.89; p=0.2135). Final data on OS are expected
        in 2013.

Secondary endpoints:
    --  An independent review committee assessment of PFS showed a 39
        percent reduction in the risk of disease worsening or death,
        which can also be referred to as a 64 percent improvement in
        PFS (HR=0.61; p0.0001). This was consistent with the magnitude
        of benefit assessed by the trial investigators.
    --  The one-year survival rate was 66 percent for the placebo arm
        versus 72 percent in the Avastin arm (p = 0.052).
    --  The study also showed that during the progression free time
        patients were able to maintain both their functional
        independence and a number of relevant health-related quality of
        life measures, emphasising the importance of extending the PFS
        time for patients. An additional benefit was that patients in
        the Avastin arm required less corticosteroids as a result of
        the extended PFS time.

About the AVAglio study

AVAglio is a phase III, randomised, double blind, placebo controlled trial 
that assessed the efficacy and safety profile of Avastin in combination with 
radiation and temozolomide chemotherapy following surgery or biopsy in 
patients with newly diagnosed glioblastoma. Patients were randomised to 
receive either:
    --  Avastin plus radiation and temozolomide chemotherapy for six
        weeks followed by a four-week break. Patients then received
        Avastin and temozolomide for up to six cycles, followed by
        Avastin alone until disease progression.
    --  Radiation, temozolomide and placebo for six weeks followed by a
        four-week break. Patients then received temozolomide and
        placebo for up to six cycles, followed by placebo until disease
        progression.

The co-primary endpoints of the study were overall survival and progression 
free survival as assessed by trial investigators. Secondary endpoints included 
PFS as assessed by an independent review committee, one- and two-year survival 
rates, health-related quality of life measures and safety profile. By meeting 
its co-primary endpoint of progressions free-survival, AVAglio is the first 
positive phase III study in newly diagnosed glioblastoma since 2005.

About glioblastoma
Glioma (cancer of the glial cells) is the most common type of malignant 
primary brain tumour (a tumour that originates in the brain), accounting for 
approximately one third of all cases diagnosed(1). Glioblastoma (or 
glioblastoma multiforme; GBM) is the most common and the most aggressive type 
of glioma(1). Globally, the incidence of GBM is approximately 3 to 4 in 
100,000 people annually(2), which means that an estimated 240,000 people 
worldwide get diagnosed with GBM every year.
Glioblastoma is a rational therapeutic target for Avastin as these tumours 
have among the highest levels of vascular endothelial growth factor (VEGF) of 
any solid tumour.

About Avastin: Over 8 Years of Transforming Cancer Care
With the initial approval in the USA for advanced colorectal cancer in 2004, 
Avastin became the first anti-angiogenic therapy made widely available for the 
treatment of patients with an advanced cancer.

Today, Avastin is continuing to transform cancer care through its proven 
survival benefit (overall survival and/or progression free survival) across 
several types of cancer. Avastin is approved in Europe for the treatment of 
advanced stages of breast cancer, colorectal cancer, non-small cell lung 
cancer, kidney cancer and ovarian cancer, and is available in the USA for the 
treatment of colorectal cancer, non-small cell lung cancer and kidney cancer. 
In addition, Avastin is approved in the USA and almost 40 other countries 
worldwide for the treatment of patients with progressive glioblastoma 
following prior therapy. Avastin is approved in Japan for the treatment of the 
advanced stages of colorectal, non-small cell lung cancer and breast cancer. 
Avastin is the only anti-angiogenic therapy available for the treatment of 
these numerous advanced cancer types, which collectively cause over 2.5 
million deaths each year.

Avastin has made anti-angiogenic therapy a fundamental pillar of cancer 
treatment today - over one million patients have been treated with Avastin so 
far. A comprehensive clinical programme with more than 500 ongoing clinical 
trials is investigating the use of Avastin in over 50 tumour types.

About Avastin: Mode of Action 
An independent blood supply is critical for a tumour to grow beyond a certain 
size (2mm) and spread (metastasise) to other parts of the body. Tumours 
develop their own blood supply in a process called angiogenesis by releasing 
vascular endothelial growth factor (VEGF) - a key driver for tumour growth. 
Avastin is an antibody that precisely targets and inhibits VEGF for continuous 
tumour control. Avastin's precise VEGF inhibition allows it to be combined 
effectively with a broad range of chemotherapies and other anti-cancer 
treatments with limited additional impact on the side effects of these 
therapies.

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused 
healthcare with combined strengths in pharmaceuticals and diagnostics. Roche 
is the world's largest biotech company with truly differentiated medicines in 
oncology, virology, inflammation, metabolism and CNS. Roche is also the world 
leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer 
in diabetes management. Roche's personalized healthcare strategy aims at 
providing medicines and diagnostic tools that enable tangible improvements in 
the health, quality of life and survival of patients. In 2011, Roche had over 
80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. 
The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, 
is a wholly owned member of the Roche Group. Roche has a majority stake in 
Chugai Pharmaceutical, Japan. For more information: www.roche.com.

All trademarks used or mentioned in this release are protected by law.
    Additional information
    --  Roche in Oncology:
        www.roche.com/media/media_backgrounder/media_oncology.htm

References

1.Central Brain Tumor Registry of the United States (CBTRUS) 2012. CBTRUS 
Statistical Report: Primary Brain and Central Nervous System Tumors Diagnosed 
in the United States in 2004-2008 (Revised March 23, 2012). 
http://www.cbtrus.org/reports/reports.html. Last accessed 1 August 2012.
2.Parkin DM, Whelan SL, Ferlay J, et al. Cancer Incidence in Five Continents. 
Vol. VIII. Lyon, France: International Agency for Research on Cancer 
Scientific Publications No. 155, 2002.



Roche Group Media Relations Phone: +41 -61 688 8888 / 
e-mail:basel.mediaoffice@roche.com Alexander Klauser (Head) Silvia Dobry 
Daniel Grotzky Štěpán Kráčala

SOURCE: Roche

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