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GSK Announces Results of First Phase III Trial Evaluating Tykerb(R) (Lapatinib) Plus Herceptin(R) (Trastuzumab)
Date:5/16/2008

Highlights Include:

-- Results demonstrating that TYKERB and trastuzumab together resulted in a clinically meaningful extension of progression-free survival (PFS)

-- Combining TYKERB and trastuzumab to attack both the inside and outside of the HER2 receptor may create a more complete HER2 blockade

-- Data demonstrating activity of TYKERB alone despite patients' previous treatment with multiple lines of trastuzumab and chemotherapy

LONDON and PHILADELPHIA, May 16 /PRNewswire-USNewswire/ -- GlaxoSmithKline today announced positive data from the first-ever randomized, multi-center, open label Phase III trial of the combination of two targeted agents, TYKERB and trastuzumab, in women with HER2-positive metastatic breast cancer (1). HER2-positive breast cancer is a particularly aggressive form of cancer that affects approximately 25 to 30 percent of breast cancer patients (2). The study results demonstrated a benefit from the combination. Both treatments target the HER2 (ErbB2) protein but work in different ways (1). Trastuzumab attaches to the outside of the HER2 protein, while TYKERB goes inside the cell to block signals from the HER2 protein for the cancer to grow (3). GlaxoSmithKline Oncology will present these and other new data in breast cancer at the annual American Society of Clinical Oncology (ASCO) meeting in Chicago beginning Friday, May 30th.

"Many women with HER2 positive breast cancer are still very active and living full lives, yet when their disease progresses after trastuzumab and chemotherapy, we have had limited treatment options. Therefore it is important to study options that may eventually help women in their fight against this disease," said lead investigator Joyce O'Shaughnessy, M.D., Baylor-Sammons Cancer Center, Texas Oncology, PA, US Oncology, Dallas, TX. "Effectively attacking HER2 from multiple angles is an exciting and innovative approach, and demonstrates the significant advances being achieved in t
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SOURCE GlaxoSmithKline
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