Glaxo Reports Positive Data On Tykerb for Breast Cancer Treatment

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Tykerb and Breast Cancer Treatment

Activity demonstrated for the first time in the treatment of first-line metastatic HER2-(ErbB2) positive breast cancer in combination with paclitaxel (Taxol(R)) one of the most commonly used chemotherapies.

Activity in brain metastases associated with HER2-positive breast cancer, an area of significant unmet medical need.

19% of patients on TYKERB monotherapy had reduction in brain metastases.

In trial extension, reduction in brain metastases found in 40% of patients on TYKERB + capecitabine combination

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GlaxoSmithKline today announced positive data from three key studies on its first-in-class, oral small molecule HER2 kinase inhibitor, TYKERB(R) (lapatinib). Results of these and other important TYKERB studies are being presented this week at the 2007 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Illinois. The use of TYKERB in these settings is investigational.

"The robust clinical data presented for TYKERB at ASCO further demonstrate the great potential of this drug as an essential component of treatment regimens for women with HER2-positive breast cancer," said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GSK. "GSK is dedicated to an ongoing TYKERB clinical program to identify additional treatment regimens, as well as patient populations that may respond to TYKERB. The data presented at ASCO this week underscore our unrelenting commitment to improving treatment for these patients."

TYKERB in Combination with Paclitaxel as First-Line Treatment for Patients with Metastatic or Relapsed Advanced Breast Cancer (Abstract #1011, Embargoed until June 3, 9:00 AM, CDT)

Paclitaxel is one of the most commonly used chemotherapies in breast cancer. Therefore, the evaluation of TYKERB in combination with this treatment is of high importance.

This large, randomized, multicenter, prospective trial evaluated a total of 580 patients either negative or untested for HER2 overexpression. While the combination therapy did not demonstrate an incremental benefit for patients with HER2-negative disease, an analysis of 91 patients who were retrospectively identified as having HER2-positive disease showed that TYKERB plus paclitaxel increased progression-free survival in patients with HER2-positive breast cancer not previously treated with trastuzumab. Results as follows represent the combination of TYKERB plus paclitaxel (n=52) versus paclitaxel alone (n=39), respectively, in patients with HER2-positive disease:

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