Download New Herceptin results confirm impressive reduction in risk of cancer

New Herceptin results confirm impressive reduction in risk of cancer returning in
women with aggressive form of early-stage breast cancer
Fourth large phase III trial establishes and confirms Herceptin’s superiority to chemotherapy
alone
Roche announced today that a fourth large phase III trial in early-stage HER2-positive breast cancer has
shown that adding Herceptin (trastuzumab) to chemotherapy significantly reduces the risk of cancer
coming back compared to chemotherapy alone. This study follows three earlier phase III studies which
also confirmed Herceptin’s superiority to chemotherapy alone in early-stage breast cancer. HER2positive breast cancer is a particularly aggressive form of the disease which affects approximately 20 –
30% of women with breast cancer.a
“The results from Herceptin’s development programme in early breast cancer have been nothing less
than remarkable, commented William M. Burns, CEO of Roche’s Pharmaceuticals Division. “Four large
trials in the past five months have delivered outstanding efficacy and safety from a vast patient pool and
with a variety of treatment regimens, more than two years earlier than planned. Roche, the medical
community and regulatory authorities around the world are urgently working together to secure access to
Herceptin for early-stage HER2-positive breast cancer patients as soon as possible, and filing in Europe
could happen as early as the beginning of 2006.”
The interim analysis of the BCIRG 1 006 study shows that Herceptin combined with two chemotherapy
regimens significantly reduced the risk of cancer coming back at an early stage for HER2-positive breast
cancer patients. Findings from the three earlier trials showed that Herceptin impressively reduced the risk
of cancer recurrence by about half. 2 All in all, data from nearly 12,000 patients analysed now provide
consistent evidence of Herceptin’s effectiveness as adjuvant treatment for early-stage HER2-positive
breast cancer, regardless of when or to which type of chemotherapy regimen it is added.
About the BCIRG 006 Study
Enrolment to the BCIRG 006 trial began in March 2001 and approximately 3,200 patients have been
enrolled in 43 countries. The study was a randomised, controlled trial that evaluated the combination of
doxorubicin and cyclophosphamide (AC) followed by docetaxel, with or without Herceptin, and
carboplatin plus docetaxel and Herceptin (TCH), in women with early-stage HER2-positive breast cancer.
Both lymph node-positive and lymph node-negative patients were eligible for entry into the trial.
The interim analysis met its primary efficacy endpoint by showing statistically significant improvements in
disease-free survival (the length of time after treatment during which no disease is found) for both
Herceptin-containing arms. According to the study sponsors, the reduction in the risk of disease
recurrence versus chemotherapy alone was 51% in the arm adding Herceptin to docetaxel following AC,
and 39% in the TCH arm. Although the secondary endpoint of overall survival had not yet been reached
at the interim analysis, an improvement in overall survival is possible as the data mature.
The interim analysis compared each of the two Herceptin-containing arms versus chemotherapy alone
and did not include a comparison of the two Herceptin-containing regimens. These data will become
available in due time as the study matures.
The BCIRG 006 study has an external Independent Data Monitoring Committee (IDMC) that regularly
reviews safety data. No safety concerns were raised by the IDMC. Clinically significant, yet rare, cardiac
events were seen in 2.3% of patients who received AC chemotherapy followed by docetaxel and
Herceptin, and in 1.2% of those who received carboplatin plus docetaxel and Herceptin, versus 1.2% of
those who receive AC chemotherapy followed by docetaxel alone. Patients in this study will continue to
be followed for any side effects.
The BCIRG 006 study is supported by sanofi-aventis and Genentech, and conducted by BCIRG, who will
work to submit this data for presentation at the 2005 San Antonio Breast Cancer Symposium (SABCS),
December 8 to 11, 2005.
1
2
Breast Cancer International Research Group
HERA – HERceptin Adjuvant (international study), NCCTG N9831 (US study) and NSABP B-31 (US study )
About breast cancer and Herceptin
Eight to nine percent of women will develop breast cancer during their lifetime, making it one of the most
common types of cancer in women.b Each year more than one million new cases of breast cancer are
diagnosed worldwide, with a death rate of nearly 400,000 people per year.
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.
Herceptin is a humanised antibody, designed to target and block the function of HER2, a protein
produced by a specific gene with cancer-causing potential. Herceptin has demonstrated improved
survival in the advanced (metastatic) setting, where its addition to chemotherapy allows patients to live
up to one-third longer than chemotherapy alone. Herceptin received approval in the European Union in
2000 for use in patients with metastatic breast cancer, whose tumours overexpress the HER2 protein. In
addition to being indicated for use in combination with docetaxel as a first-line therapy in HER2-positive
patients who have not received chemotherapy for their metastatic disease, it is also indicated as a firstline therapy in combination with paclitaxel where anthracyclines are unsuitable, and as a single agent in
third-line therapy. Herceptin is marketed in the United States by Genentech, in Japan by Chugai and
internationally by Roche. Since 1998, Herceptin has been used to treat over 230,000 HER2-positive
breast cancer patients worldwide.
Breast Cancer International Research Group
HERA – HERceptin Adjuvant (international study), NCCTG N9831 (US study) and NSABP B-31 (US
study )