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| | | | GlaxoSmithKline initiates trial of Tykerb lapatinib in patients with ErbB2-overexpressing breast.. Dec 10th 2005
cancer brain metastasis following Herceptin and cranial radiotherapy. 
GlaxoSmithKline (GSK) has announced the initiation of a global multicenter Phase II trial (known as EGF105084) to evaluate Tykerb (lapatinib) for the treatment of ErbB2-overexpressing (HER2+) breast cancer that has metastasized to the brain. Tykerb is an orally bioavailable small molecule which potently inhibits, two receptors, ErbB2 and ErbB1, and is currently in development as a first-line treatment for ErbB2-overexpressing breast cancer. Several centers, first in the USand then throughout the world, will begin enrolling patients with breast cancer who have progressive brain metastases following cranial radiotherapy and prior trastuzumab (Herceptin)-based therapy. Tykerb currently does not have regulatory approval for therapeutic use in any market.
Herceptin-based regimens have improved both systemic control and overall survival in patients with metastatic ErbB2 overexpressing breast cancer [Slamon, 2001 Cobleigh, 1999 Vogel, 2002 Burstein, 2001]. Herceptin, however, may not cross the blood-brain barrier and ErbB2-overexpressing breast cancer may have a predilection for metastases to visceral sites including the brain [Pestalozzi, 2000 Grossi, 2003, Stemmler, 2005]. As a result, central nervous system disease progression is emerging as a significant clinical problem in this patient population. Preliminary evidence of activity with Tykerb has been observed in ongoing clinical trials which have enrolled patients with ErbB2-overexpressing breast cancer brain metastases.
“This clinical trial, specifically in patients with brain metastases resulting from breast cancer, is unprecedented and underscores our continued dedication to discovering new treatment options for even the most difficult—to-treat malignancies,” said Paolo Paoletti, M.D., Senior Vice President of the OncologyMedicineDevelopmentCenter, at GSK. The EGF105084 trial will investigate the therapeutic potential of Tykerb in addressing this significant unmet clinical need.
The EGF105084 trial will enroll 220 patients to provide a more extensive analysis of safety and efficacy data in this setting. A similar population of patients was studied in a National Cancer Institute-sponsored study [Cancer Therapy Evaluation Program (CTEP) Trial 6969], and recently completed enrollment.
The EGF105084 trial is designed to assess the impact of Tykerb therapy by monitoring lesions in the brain using magnetic resonance imaging. A centralized radiological review will be conducted. Other treatment endpoints include reduction in tumor-related neurological symptoms, duration of response to therapy, time to progression at any site and overall survival.
Study participants will be separated into two cohorts:
Patients able to carry out most daily activities(ECOG Performance Status 0-1) and who have received one or two prior Herceptin-containing regimens
Patients ambulatory and capable of all self-care but unable to carry out any work activities,(ECOG Performance Status 2), or who have received more than two prior Herceptin-containing regimens
Few trials have examined the role of chemotherapy in the treatment of brain metastases from breast cancer and most studies of novel agents for breast cancer have specifically excluded patients with brain metastases.
Incidence of Brain Metastases from Breast Cancer
Approximately 20 percent of breast cancer patients with metastatic or stage IV disease are diagnosed with brain metastases, and autopsy data suggests a true incidence of nearly 30 percent. Retrospective analyses have disclosed a 28-43% incidence of brain metastases among women treated with Herceptin for stage IV ErbB2 overexpressing breast cancer across multiple institutions [Clayton, 2004 Bendell, 2003 Burstein, 2003 Weitzen, 2002 Wardley, 2002 Heinrich, 2003].
GlaxoSmithKline http://www.gsk.com
Dec 10th 2005
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