Roche To Present New Survival Data From Phase Ii, Iii And Iv Studies For Avastin, Herceptin And Xelo

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21st September 2009, 05:31pm - Views: 662






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MEDIA RELEASE PR36218


Roche to Present New Survival Data From Phase II, III and IV Studies for Avastin,

Herceptin and Xeloda


BASEL, Sept. 21 / PRNewswire-AsiaNet / --


    

    - Nearly 150 Abstracts Covering New Tumour Types, New Patient Groups and

Existing Indications to Feature in ECCO-ESMO Program


    Roche will present encouraging results from nearly 150 scientific studies 

investigating use of its major cancer medicines at ECCO 15 ESMO 34, which 

opens in Berlin, Germany today. Overall survival benefits will be 

demonstrated for Avastin(R) (bevacizumab) in malignant melanoma and for 

Herceptin(R) (trastuzumab) in gastric cancer. In addition, significant 

advances in the early treatment of colon cancer and the treatment

of early breast cancer with Xeloda(R) (capecitabine) in combination with

standard chemotherapies will be shown. Phase IV data for Avastin in lung and

breast cancers will also be presented, confirming that the benefits of

targeting VEGF inhibition are improving patient outcomes in the real-world

setting.


    "The results from our key studies are extremely encouraging because they

offer new treatment options where very few have existed for incurable cancers

like malignant melanoma, primary brain cancer and gastric cancer", said

William M. Burns, CEO of Roche's Pharmaceuticals Division. "We also have

strong phase II, III and IV data for Avastin confirming the benefits of

targeting VEGF inhibition to control cancer growth in advanced colorectal,

breast and lung cancers, which continue to claim millions of lives every

year", he added.


    Key Avastin Data


    Avastin in malignant melanoma (BEAM)

 

    Phase II trial: Encouraging results will be presented from a trial of

Avastin in combination with carboplatin and paclitaxel chemotherapy in

patients with previously untreated advanced malignant melanoma, a highly

aggressive cancer that is incurable and can be rapidly fatal once it

spreads.

 

    Avastin in primary brain cancer (BRAIN)

 

    Phase II trial: Results assessing corticosteroid use and neurocognitive

function in patients with glioblastoma (GBM) at first or second relapse

treated with Avastin will show the positive and stabilising impact of

Avastin in patients with this rare and aggressive form of primary brain

cancer. Most patients experience relapse or progression of their disease

following initial treatment and when the disease returns, prognosis is

very poor. Improving day to day life for patients is an important

treatment aim.

 

    Avastin in metastatic colorectal cancer (BOXER and BEAT)

 

    Phase II trial: Results from BOXER will show the percentage of patients

with liver-only metastases from their colorectal cancer and unsuitable for

upfront liver surgery who will become eligible for potentially life-saving

(curative) surgery when treated with Avastin plus Xeloda and oxaliplatin

(XELOX). The study will also show the rate of shrinkage or disappearance

of liver metastases.

 

    Phase IV trial: BEAT, a large non-randomised trial, will report on the

safety and efficacy of Avastin plus chemotherapy in elderly patients with

metastatic colorectal cancer (mCRC). This is an important study as older

patients are often under-represented in clinical trials and in mCRC they

represent a significant number of patients.

 

    Avastin in lung cancer (SAiL and ARIES)

 

    Phase IV trial: Encouraging final efficacy and safety results from the

SAiL study - an international study in over 2,000 patients with advanced

non-small cell lung cancer (NSCLC) representative of physician clinical

practice will be presented alongside results from ARIES, a US phase IV

study enrolling approximately 2,000 patients with lung cancer including

elderly patients and patients with brain metastases. Both studies add to

the growing body of evidence supporting use of Avastin first line to

progression in order to maintain optimal disease control.


    Avastin in breast cancer (ATHENA and AVADO)

 

    Phase IV trial: ATHENA will confirm the safety and efficacy of Avastin

when combined with taxane or non-anthracycline chemotherapy in a broad

patient population representative of general oncology practice. The data

reinforces the benefits of first-line use of Avastin in patients with

metastatic breast cancer (mBC).

 

    Phase III trial: Minimizing side effects is a key treatment goal in mBC,

so new data from AVADO demonstrating quality of life benefits for patients

who receive Avastin treatment in combination with docetaxel chemotherapy

compared to those who receive placebo and chemotherapy will be welcome

news for physicians and their patients.


    Key Herceptin Data


    Herceptin in HER-2 positive advanced stomach cancer

 

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    Phase III trial: A new and detailed analysis of the Phase III ToGA study

investigating the use of Herceptin added to chemotherapy in patients with

inoperable, locally advanced, recurrent and/or metastatic HER2-positive

stomach cancer will reveal important new findings for patients whose

tumours express a particularly high level of HER2. Stomach cancer is the

second most common cause of cancer-related death worldwide with over

1,000,000 new cases diagnosed each year.


    Key Xeloda Data


    Xeloda in colon cancer (NO16968 / XELOXA)

 

    Phase III trial: The first efficacy results from the XELOXA adjuvant

study, the largest trial completed in patients with Stage III colon

cancer, will show significant disease-free survival benefits with oral

Xeloda in combination with intravenous oxaliplatin (XELOX) versus 5-FU

immediately following surgery.

 

    Xeloda in neo-adjuvant breast cancer

 

    Phase III trial: The independent Austrian Breast Cancer Study Group

(ABCSG-24 trial) will report impressive results from their study

demonstrating the clinical benefit of capecitabine (Xeloda) in combination

with anthracycline and taxane-containing regimens prior to surgery in

women with HER2-positive or HER2-negative early breast cancer.

Additionally, data from three large independent phase III adjuvant

studies, ICE, GAIN and CIBOMA will be presented demonstrating the

potential role of Xeloda-containing therapies in the adjuvant setting.


    About Roche


    Information about the Roche Group is available on the Internet at



    All trademarks used or mentioned in this release are protected by law.


    SOURCE: Roche




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