GlaxoSmithKline and
Massachusetts General Hospital Cancer Center today announced the initiation
of a landmark international breast cancer clinical trial, TEACH (Tykerb(R)
Evaluation After CHemotherapy). This will be the first Phase III study to
investigate whether adjuvant treatment with lapatinib (Tykerb(R)) will
improve disease-free survival in women with early-stage HER2
(ErbB2)-positive breast cancer, including those with positive and negative
node involvement. An adjuvant therapy is one that is administered in
addition to primary surgical or radiation treatment to lower risk of
disease progression. Approximately 3,000 women will be enrolled from more
than 450 centers in more than 30 countries. Lapatinib is an investigational
drug that is not marketed for any indication in any country at this time.
"The initiation of this trial represents another step toward
understanding the role of targeted therapies in extending disease-free
survival," said Dr. Paul Goss, Director of Breast Cancer Research,
Massachusetts General Hospital Cancer Center, who proposed the TEACH study
and will chair the International Steering Committee. "Women who have
HER2-positive breast cancer are at a high risk of the disease returning,
which is of great concern to patients and physicians. The landmark TEACH
study will be the first to investigate the use of a dual EGFR and HER2
inhibitor as an adjuvant treatment for women with HER2-positive breast
cancer."
Between 20% and 30% of human breast cancers overexpress HER2(1,2).
Because of the distinct clinical features of HER2-positive breast cancer,
women have a high risk of disease recurrence and thus, poorer prognosis(3).
In current clinical practice trastuzumab (Herceptin(R)) is now becoming
part of standard adjuvant therapy together with chemotherapy. However, many
thousands of women with HER2-positive cancer have already received adjuvant
therapy without trastuzumab. Although these patients remain at elevated
risk of relapse, there is no data to support initiating additional
trastuzumab treatment in patients who did not receive trastuzumab within
seven weeks of completing their adjuvant therapy. In addition, trastuzumab
is not licensed for use in all countries.
"Researchers are continually seeking ways to stay one step ahead of
cancer. We must be proactive with treatments for women who have a
distinctive disease prognosis -- those with HER2-positive breast cancer,"
said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine
Development Center at GSK. "GlaxoSmithKline is excited that lapatinib will
be used in the first study that will investigate the use of a dual EGFR and
HER2 inhibitor as an adjuvant treatment for these women -- the TEACH
trial."
Lapatinib is a dual kinase inhibitor that potently blocks the action of
both EGFR (ErbB1) and HER2 receptors within the cancer cell, which are
associated with cell proliferation and tumor growth(4). A small molecule
tyrosine kinase inhibitor once-daily oral medication, lapatinib is
currently in late-stage clinical development for the treatment of patients
with advanced metastatic breast cancer and in earlier phases of
investigation for treatment of a range of other solid tumors. In a phase
III study of Tykerb in combination with capecitabine in patients who have
progressed on Herceptin treatment was stopped early by an Independent Data
Monitoring Committee due to positive results. The registration approval is
currently under review by regulatory authorities in US and various
EU/International countries.
About TEACH
The TEACH trial will be conducted at approximately 450 clinical
research sites globally and approximately 3,000 women will be enrolled. The
study is designed to compare the efficacy and safety of lapatinib versus
placebo in women treated for early-stage, HER2-positive breast cancer who
have no clinical or radiographic evidence of disease. Participants must
have completed primary adjuvant chemotherapy prior to study entry but must
not have received trastuzumab. Patients will be randomized to receive
lapatinib 1500mg or matching placebo orally administered once daily. Women
will continue treatment for a maximum of 12 months or until disease
recurrence, development of a second primary cancer, withdrawal from study
drug due to unacceptable toxicity, or consent withdrawal. All women will be
followed until death or until study closure. The primary efficacy endpoint
for analysis is disease- free survival. For further information doctors can
visit clinicaltrials or call 1-877-379-3718.
TEACH Steering Committee
The TEACH trial was proposed by the study chair Dr. Paul Goss, Director
of Breast Cancer Research, Massachusetts General Hospital Cancer Center.
The study protocol was established through the collaboration of members on
the TEACH Steering Committee, which includes the following panel of leading
world experts: Dr. Frances Boyle, Sydney, Australia; Dr. Aman Buzdar,
Houston, Texas, USA; Dr. Bent Ejlertsen, Copenhagen, Denmark; Dr. Dianne
Finkelstein, Boston, Massachusetts, USA; Dr. Pierre Fumoleau, Dijon,
France; Dr. William Gradishar, Chicago, Illinois, USA; Dr. James Ingle,
Rochester, Minnesota, USA; Dr. Manfred Kaufmann, Frankfurt, Germany; Dr.
Julie D. Maltzman, Collegeville, Pennsylvania, USA; Dr. Miguel Martin,
Madrid, Spain; Dr. Beverly Moy, Boston, Massachusetts, USA; Dr. Joyce
O'Shaughnessy, Dallas, Texas, USA; Dr. Martine Piccart, Brussels, Belgium;
Dr. Kathleen Pritchard, Toronto, Canada and Prof Ian Smith, London, UK.
About Massachusetts General Hospital Cancer Center
An integral part of one of the world's most distinguished medical
centers, the Massachusetts General Hospital Cancer Center is chosen by more
cancer patients than any other hospital in New England. Its commitment to
eradicating cancer is fueled by scientific investigation conducted as part
of the largest hospital-based research program in the United States. Known
for providing individualized, compassionate care to both adults and
children, the Cancer Center is comprised of 16 fully integrated,
multidisciplinary clinical programs and a vast network of support and
educational services. The Cancer Center is consistently ranked as one of
the best in the country by U.S. News and World Report, and Massachusetts
General Hospital nurses were the first in the state to achieve Magnet
status as part of a hospital-wide recognition for exceptional nursing care.
Through a powerful synergy between scientists in the laboratories and
physicians at the bedside, the Cancer Center fosters innovation in basic,
translational and clinical research. It is a founding member of the DF/HCC,
a Harvard Medical School consortium designated by the National Cancer
Institute as a comprehensive cancer center. This prestigious seven-member
center comprises the largest research collaboration in the country. Also,
through the DF/PCC partnership, the Cancer Center and Dana-Farber/Brigham &
Women's Cancer Center collaborate on joint clinical trials, education,
training programs and quality of care improvements.
About GlaxoSmithKline
GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to improving the
quality of human life by enabling people to do more, feel better, and live
longer. For company information, visit GlaxoSmithKline at
gsk.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, the company cautions investors that any
forward-looking statements or projections made by the company, including
those made in this announcement, are subject to risks and uncertainties
that may cause actual results to differ materially from those projected.
Factors that may affect the Group's operations are described under 'Risk
Factors' in the Operating and Financial Review and Prospects in the
company's Annual Report on Form 20-F for 2005.
Lapatinib was discovered by GlaxoSmithKline and is being developed as
an orally administered therapy for breast cancer and other solid tumors.
Tykerb(R) (lapatinib) is a registered trademark of the GlaxoSmithKline
group of companies in the United States and Europe.
Herceptin(R) is a registered trademark of Genentech, Inc. in the U.S.
and Roche Pharmaceuticals in Europe.
GlaxoSmithKline
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View drug information on Herceptin; Tykerb.