Media Release
Basel, 26 April 2005 1 2 3
Herceptin
improves survival for the first time in women with early-stage HER2-positive breast cancer
Joint
interim analysis of two large phase III clinical trials provides first positive data of a targeted therapy
after initial surgery
Roche and Genentech today announced that a joint
interim analysis of two large North American phase III studies showed that the use of Herceptin (trastuzumab)
significantly increases survival for women with early-stage HER2-positive breast cancer. These results
provide the first evidence that Herceptin has the potential to reduce the risk of cancer coming back
at an early stage and to prolong life for women with this aggressive form of the disease.
“These
results in early-stage HER2-positive breast cancer suggest that Herceptin may increase the chance of
long-term survival by preventing the development of metastatic disease, and while further follow-up
is necessary, they offer new hope to women suffering from this particularly aggressive form of breast
cancer,” said William M. Burns, CEO of Roche’s Pharmaceuticals Division. “Given these latest data, determining
HER2 status as soon as a patient is diagnosed is becoming an essential step in the management of breast
cancer.”
The two studies evaluated the use of Herceptin plus chemotherapy
compared to chemotherapy alone following initial surgical treatment (adjuvant treatment). The joint
interim analysis met its specified primary and secondary endpoints by showing statistically significant
improvements in disease-free survival (the length of time after treatment during which no disease is
found) and overall survival. According to the National Cancer Institute (NCI), these results will be
presented at the American Society of Clinical Oncology (ASCO) annual meeting, May 13 – 17, 2005.
Dr
Martine Piccart, Head of the Medicine Department at the Jules Bordet Institute in Brussels and lead
investigator of the HERA (HERceptin Adjuvant) study, another
large Herceptin adjuvant trial, commented, “The medical community has eagerly awaited results of Herceptin
in the early-stage breast cancer setting, and these interim data demonstrate for the first time that
a targeted therapy has a clinical benefit in early-stage HER2-positive breast cancer. The news of these
North American trials also heightens anticipation around the upcoming interim analysis of the HERA study,
which similarly investigated Herceptin in early breast cancer, but with a wider range of chemotherapy
regimens.”
Herceptin has already demonstrated improved survival in the
advanced (metastatic) setting, where its addition to first-line chemotherapy allows patients to live
up to one-third longer than chemotherapy alone. Since 1998, Herceptin has been used to treat over 230,000
metastatic HER2-positive breast cancer patients worldwide. HER2-positive breast cancer affects approximately
20 – 30% of women with breast cancer and is a particularly aggressive form of the disease with a poor
prognosis.
About
the NCCTG and NSABP studies
The two studies were sponsored by the NCI, part of
the National Institutes of Health, and conducted by a network of researchers led by the National Surgical
Adjuvant Breast and Bowel Project (NSABP) and the North Central Cancer Treatment Group (NCCTG), who
conducted this prospectively-designed joint interim analysis. The NCCTG study enrolled its first patient
in June 2000 and has enrolled 3,406 patients to date; the NSABP study began enrolment in March 2000
and has enrolled 2,085 patients to date. The joint interim analysis was based on information from 3,300
patients. These studies will stop enrolling new patients and the cooperative groups will continue to
monitor patients for longer-term data. Each of the studies was a randomised, controlled trial that evaluated
the combination of doxorubicin and cyclophosphamide (AC) followed by paclitaxel, with or without Herceptin
using different treatment schedules of paclitaxel in women with early stage HER2-positive breast cancer.
Adverse events in these studies were consistent with those seen
in previous Herceptin clinical trials. Each of these studies has an independent, external Data Monitoring
Committee (DMC) that reviewed data from the studies, including cardiac safety data. The DMCs monitored
safety data on a regular basis and there were three to four percent more cases of serious or life-threatening
(and in rare cases, fatal) cardiac events, most commonly congestive heart failure (weakening of the
heart muscle), in patients receiving the combination of Herceptin plus chemotherapy. These findings
have been reported previously. Patients in these studies will continue to be followed for any additional
side effects.
About the HERA study
Enrolment
to the HERA trial, conducted by the Breast International Group (BIG)
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.
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 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 first-line therapy in
combination with paclitaxel where anthracyclines are unsuitable, and as a single agent in second- and
third-line therapy. Herceptin is marketed in the United States by Genentech, in Japan by Chugai and
internationally by Roche.
About Roche
Headquartered
in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the
fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the
early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range
of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics,
the leading supplier of medicines for cancer and transplantation and a market leader in virology. In
2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics
Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries
and has R&D agreements and strategic alliances with numerous partners, including majority ownership
interests in Genentech and Chugai. Additional information about the Roche Group is available on the
Internet (www.roche.com).
All trademarks
used or mentioned in this release are legally protected.
Further information:
- Herceptin: www.HER2status.com and www.heratrial.com
- Genentech: www.gene.com
- Cancer: www.health-kiosk.ch
- Roche in Oncology: www.roche.com/pages/
downloads/company/pdf/mboncology05e_a.pdf
References:
1.
Harries M, Smith I. The development and clinical use of trastuzumab (Herceptin). Endocr Relat
Cancer 9: 75-85, 2002.
2. Collaborative partners for the HERA study include: Roche,
the Breast International Group (BIG) and its affiliated collaborative groups, plus non-affiliated collaborative
groups, and independent sites
3. World Health Organization, 2000