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21.09.2009 – 07:05

Roche Pharmaceuticals

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

Basel, Switzerland (ots/PRNewswire)

- 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

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

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For more information please contact: Christine McMenamin, Roche,
+41-79-618-7671; Anne Cameron, Galliard Healthcare, +44-7590-711-190

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