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Important progress in treatment of early and late stage breast cancer with Herceptin, Avastin and T-DM1.
Basel, 9 December 2009
Roche to present new results that could offer a better future to women with early and very advanced breast cancer, at the CTRC-AACR San Antonio Breast Cancer Symposium
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that new 5 year follow-up data from two pivotal studies with Herceptin® (trastuzumab) in early breast cancer; key results from a study of Avastin® (bevacizumab) in the second-line treatment of advanced breast cancer and strong data on the use of trastuzumab-DM1 (T-DM1), the first antibody-drug conjugate in development for very advanced HER2-positive breast cancer, will all be presented during the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) from 9 to 13 December 2009.
"Breast cancer is the most common cancer among women worldwide with more than one million new cases diagnosed every year and nearly 400,000 deaths, so it is vital that we continue to provide more treatment options" said William M. Burns, CEO of Roche Pharma. "The much anticipated data on Herceptin, Avastin and the investigational drug T-DM1 will be welcomed by physicians treating women with early and very advanced stages of breast cancer as it will offer them more choices for fighting this devastating disease."
Two Herceptin studies in early breast cancer, five year follow up data (N9831, BCIRG 006)
- 5-years of follow-up data will be presented from these pivotal phase III studies that have already shown efficacy in patients when adding 12 months of Herceptin to standard therapy.
- Both studies were seeking to answer questions the medical community has been contemplating regarding the best way of giving their patients Herceptin treatment.
Avastin RIBBON-2 study, second-line treatment data
- Avastin is well established as a first-line treatment for women with advanced breast cancer. RIBBON-2 will report on the benefits of Avastin in combination with commonly used chemotherapies in the second-line setting where currently the only option is subsequent chemotherapy.
T-DM1 4374 study in very advanced breast cancer
New data from a phase II study (TDM4374) in a very advanced patient population who have exhausted other treatment options will be presented. This follows on from another phase II study (TDM4258) that was presented at ASCO 2009 which showed encouraging results in women with advanced HER2-positive breast cancer.
In addition, further data from the phase II study BO17929 will be presented, demonstrating that the combination of pertuzumab and trastuzumab shows efficacy in patients with HER2 positive advanced breast cancer whose disease had progressed during prior treatment with Herceptin plus chemotherapy.1 The data, which suggest that combining pertuzumab and trastuzumab may offer an effective new treatment option to patients with HER2-positive advanced breast cancer, have been accepted as a poster presentation on Saturday 12 Dec, 17:30 19:30, Poster Session 5, Exhibit Halls A-B.
Details of key studies being presented:
Herceptin N9831 study
The study is part of the official SABCS press programme on Saturday 12 Dec., 08:00 hrs.
| Dr E. Perez, et al |
Results of chemotherapy alone, with sequential or concurrent addition of trastuzumab in the NCCTG N9831 HER2-positive adjuvant breast cancer trial. |
Oral presentation Saturday 12 Dec, 15:00, General Session 6, Exhibit Hall D. |
Herceptin BCIRG 006 study
| Dr. D. Slamon, et al |
Phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC -> T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC -> TH) with docetaxel, carboplatin and trastuzumab (TCH) in Her2neu positive early breast cancer patients: BCIRG 006 study. |
Oral presentation Saturday 12 Dec, 09:45, General Session 5, Exhibit Hall D. |
Avastin RIBBON-2 study
The study is part of the official SABCS press programme on Friday 11 Dec., 12:30 hrs.
| Dr. A. Brufsky, et al |
RIBBON-2: A randomized, double-blind, placebo-controlled, phase III trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy for second-line treatment of HER2-negative metastatic breast cancer. |
Oral presentation Friday 11 Dec, 15:00, General Session 4, Exhibit Hall D. |
T-DM1 4374 study
| Dr. I. Krop, et al |
A phase II study of trastuzumab-DM1 (T-DM1), a novel HER2 antibody-drug conjugate, in patients previously treated with lapatinib, trastuzumab, and chemotherapy. |
Poster presentation Saturday 12 Dec, 07:00 09:00. Poster Discussion 7, Ballroom B. |
The above mentioned studies and data represent the latest results of clinical research for each treatment and are not necessarily part of the indicated licence in each country. For detailed label information, visit the website of your health authority or the EMEA website http://www.emea.europa.eu/
In HER2-positive breast cancer, increased quantities of the HER2 protein are present on the surface of the tumour cells. This is known as 'HER2-positivity'. High levels of HER2 are present in a particularly aggressive form of the disease which responds poorly to chemotherapy. Research shows that HER2-positivity affects approximately 20-30 percent of women with breast cancer.2
The 2009 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) takes place from 9 to 13 December 2009. Full details can be found at http://www.sabcs.org/.
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) Baselga J. et al., Abstract 1004. American Society of Clinical Oncology Annual Meeting 2007.
2) Harries M, Smith I. The development and clinical use of trastuzumab (Herceptin). Endocr Relat Cancer 9: 75-85, 2002. |
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