Investor Update
Basel, 25 November, 2009
Avastin filed for broader breast cancer label in Europe for use in combination with standard chemotherapies
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that they have filed to extend the current European label of Avastin (bevacizumab) in patients with metastatic breast cancer to allow its use in combination with a broader range of standard chemotherapies. Avastin is currently licensed in the EU as first-line treatment for patients with metastatic breast cancer in combination with paclitaxel or docetaxel.
The new filing is supported by data from the double-blind, phase III RIBBON 1 study, the first phase III study to show Avastin’s benefit when combined with Xeloda (capecitabine) or anthracycline-based chemotherapies in this patient population as well as confirming the benefits of Avastin when combined with taxane-based chemotherapies. Avastin used at its standard dose (15 mg/q3w) was shown to increase the time women with breast cancer lived without their disease advancing (known as progression-free survival) compared to chemotherapy alone.
Patients receiving Avastin plus taxane or anthracycline-based chemotherapies had a 55 percent increase in the chance of being alive without disease progression compared to those who received the chemotherapies alone (hazard ratio=0.64; p<0.0001). Patients receiving Avastin plus Xeloda had a 45 percent increase in the chance of being alive without disease progression compared to those who received the chemotherapy alone (hazard ratio=0.69; p=0.0002).
RIBBON 1 is the third phase III study to demonstrate the benefit of Avastin in metastatic breast cancer after the pivotal E2100 (Avastin and paclitaxel) and the AVADO (Avastin and docetaxel) study which form the basis of the currently approved EU label allowing combination of Avastin with paclitaxel and docetaxel to treat women with metastatic breast cancer.
Each year more than one million women are diagnosed with breast cancer worldwide, and over 400,000 of these women die from their disease1.
About RIBBON 1
RIBBON 1 is a global, double-blind, randomised phase III trial with 1,237 patients who did not receive previous chemotherapy for their HER2-negative metastatic breast cancer. RIBBON 1 comprised two independently-powered treatment cohorts that evaluated Avastin with different types of chemotherapies in people with advanced HER2-negative breast cancer:
- Cohort One: Avastin or placebo plus a taxane (protein-bound paclitaxel or docetaxel) or anthracycline-based chemotherapies (doxorubicin- or epirubicin-based regimens)
- Cohort Two: Avastin or placebo plus Xeloda
Standard anthracyline-based regimens included the following:
- FEC (Fluorouracil (5FU), epirubicin and cyclophosphamide),
- EC (epirubicin and cyclophosphamide),
- AC (doxorubicin and cyclophosphamide),
- FAC (Fluorouracil (5FU), doxorubicin and cyclophosphamide)
The primary objective of RIBBON 1 was to demonstrate superiority in progression-free survival of Avastin containing treatment arms compared to the control arms. Both Avastin containing cohorts yielded superior progression-free survival.
Secondary endpoints for the study included response rate, duration of response, overall survival, PFS by independent review, safety and tolerability.
About Avastin
Avastin is an antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor). VEGF is a key driver of tumour angiogenesis – an essential process required for a tumour to grow and to spread (metastasize) to other parts of the body. Avastin’s precise mode of action allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments. Avastin helps to control tumour growth and extend survival with only a limited impact on the side effects of chemotherapy.
Avastin has proven survival benefits across several types of cancer. It is approved in Europe for the treatment of the advanced stages of four common types of cancer: colorectal cancer, breast cancer, non-small cell lung cancer (NSCLC) and kidney cancer. These types of cancer collectively cause over 2.5 million deaths each year1,2,3. In the US, Avastin was the first anti-angiogenesis therapy approved by the FDA and it is now approved for the treatment of five tumour types: colorectal cancer, non-small cell lung cancer, breast cancer, brain (glioblastoma) and kidney (renal cell carcinoma).
Over half a million patients have been treated with Avastin so far. A comprehensive clinical programme with over 450 clinical trials is investigating the use of Avastin in various tumour types (including colorectal, breast, non-small cell lung, brain, gastric, ovarian, prostate and others) and different settings (advanced or early stage disease).
About Xeloda (capecitabine)
Xeloda is a highly effective targeted oral chemotherapy offering patients a survival advantage when taken on its own or in combination with other anticancer drugs. Xeloda is converted to the active cancer-killing agent 5-FU (5-fluorouracil) directly inside the cancer cells, thus reducing damage to healthy cells. Xeloda tablets can be taken by patients in their own home, reducing the number of hospital visits.
Licensed and marketed by Roche in more than 100 countries worldwide, Xeloda has more than ten years of proven clinical experience providing an effective and flexible treatment option to over 1.8 million people with cancer.
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 personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients.
In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 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.
References
1. Garcia M et al. Global Cancer Facts & Figures. Atlanta, GA: American Cancer Society, 2007
2. WHO Cancer Factsheet N°297 – updated July 2008. Last accessed 24 March 2009 at http://www.who.int/mediacentre/factsheets/fs297/en/index.html.
3. Parkin DM et al. CA Cancer J Clin 2005; 55: 74-108.