Investor Update
Basel, 25 September 2009
Roche provides update on early-stage breast cancer study with Avastin
Roche (SIX: RO, ROG; OTCQX: RHHBY) has been informed by the National Cancer Institute and US Eastern Cooperative Oncology Group (ECOG) that they have suspended enrollment into a phase III clinical trial (E5103) evaluating Avastin® (bevacizumab) in combination with chemotherapy in women with early-stage breast cancer based on a pre-planned cardio-toxicity analysis of the first 200 patients enrolled. The protocol for the trial specifies that enrollment be suspended if six or more cases of clinical congestive heart failure (CHF) are seen in the first 200 patients. This threshold has been met.
All six of the patients received Avastin in combination with anthracycline chemotherapy. There have been no deaths due to cardiac toxicity. The observed rate of CHF in this trial to date is consistent with what has previously been reported for Avastin and described in its U.S. prescribing information.
The trial’s independent Data Safety Monitoring Board (DSMB) will evaluate the data and make a recommendation for next steps in consultation with ECOG, NCI, and the Sponsor. The DSMB also advised that patients can stay on therapy once informed.
Enrollment into E5103 began in November 2007 and 3,439 of the planned 4,950 patients have been entered into the study.
A separate phase III study in early-stage breast cancer (BEATRICE), involving patients who have a form of the disease in which receptors for oestrogen, progesterone and HER2 are absent (known as triple negative breast cancer) is close to meet its protocol specified enrolment target . No new safety signals have been observed in BEATRICE and the study continues as planned. Additional studies in the metastatic and adjuvant disease settings, in which Avastin is administered in combination with anthracycline-based chemotherapy, continue to enroll with no unexpected safety signals reported to date.
Roche is committed to exploring the benefits of Avastin in patients with early- stage breast cancer.
About E5103
E5103 is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial evaluating Avastin plus chemotherapy as adjuvant treatment following surgery in women with either lymph node-positive or high-risk, lymph node-negative, breast cancer. The primary endpoint of the study is disease-free survival (reducing the risk of the cancer returning following surgery). Secondary endpoints include safety, including cardiac toxicity, overall survival and efficacy of short-term versus long-term Avastin use. Following surgery, patients in the trial are randomized to one of three arms:
A: Doxorubicin, cyclophosphamide plus placebo (4 cycles) followed by paclitaxel plus placebo (4 cycles)
B: Doxorubicin, cyclophosphamide plus Avastin (4 cycles) followed by paclitaxel plus Avastin (4 cycles)
C: Doxorubicin, cyclophosphamide plus Avastin (4 cycles) followed by paclitaxel plus Avastin (4 cycles) followed by Avastin alone (10 cycles)
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 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.
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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.