GlaxoSmithKline Announces Data on TYKERB(R) (Lapatinib) Plus Capecitabine for the Treatment of HER2 Positive Breast Cancer Brain ...( Study Shows TYKERB Combination Reduc...)

Study Shows TYKERB Combination Reduced the Size of Brain Tumors Associated

with HER2-Positive Breast Cancer

SAN ANTONIO, Texas, Dec. 17 /PRNewswire/ -- GlaxoSmithKline announced today results from the extension arm of a Phase II study on its first-in-class, oral small molecule HER2 (ErbB2) kinase inhibitor, TYKERB(R) (lapatinib). In this study of 49 patients, the combination of TYKERB plus capecitabine (Xeloda(R)) showed a reduction in HER2-positive breast cancer that had spread to the brain and had progressed on TYKERB alone(1). Specifically, 20 percent of patients who received TYKERB plus capecitabine experienced at least a 50 percent volumetric reduction in measurable brain metastases; 37 percent of patients experienced a volumetric decrease that was greater than or equal to 20 percent. This is important because up to one-third of women with HER2-positive metastatic breast cancer may develop brain metastases during the course of their disease(2). Results of this and other important TYKERB studies are being presented at the 2007 San Antonio Breast Cancer Symposium in San Antonio, TX.

"As women live longer with advanced breast cancer, some are developing brain metastases that are getting worse despite standard treatments, such as radiation," said Nancy U. Lin, M.D., lead investigator and Instructor in Medicine, Dana-Farber Cancer Institute. "Very few medications have shown activity in the treatment of brain metastases, in particular HER2-positive metastatic breast cancer patients and therefore, these data are quite encouraging."

TYKERB, in combination with capecitabine, is approved in the United States for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane and trastuzumab (Herceptin(R))(3). Additional studies are underway to learn the full potential of TYKERB for the prevention and treatment of brai
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