Landmark Tykerb (Lapatinib) Data Published in the New England Journal of Medicine

Study Authors Also Conclude that Further Investigation Into Earlier Use in the Treatment of HER2 Positive Breast Cancer is Warranted

LONDON and PHILADELPHIA, Dec. 28 /PRNewswire/ -- Data from a Phase III study reporting that Tykerb(R) (lapatinib) plus Xeloda(R) (capecitabine) is superior to capecitabine alone in women with HER2 (ErbB2) positive advanced breast cancer who had progressed following prior therapy, including Herceptin(R) (trastuzumab), was published today in the New England Journal of Medicine (NEJM).(1) Based on the findings, the study authors concluded that given its distinct mechanism of action and activity, as a small molecule dual receptor tyrosine kinase inhibitor, lapatinib should be investigated for use in the earlier treatment of HER2 (ErbB2) positive breast cancer.(1) Lapatinib is an investigational medicinal product and has not been approved for marketing by any regulatory body.

"Patients with advanced or metastatic HER2 (ErbB2) positive breast cancer have limited options once their cancer has progressed on trastuzumab and standard initial chemotherapy regimens. There has been a clear need for alternative treatments to help women with metastatic breast cancer in this advanced setting. Lapatinib combined with capecitabine has demonstrated superior efficacy over capecitabine alone in this group of patients and we look forward to it being made available to women suffering from this devastating disease," said lead investigator Charles Geyer, M.D., Director of Breast Medical Oncology at Allegheny General Hospital, Pittsburgh, Pennsylvania, U.S.A.

Study results demonstrate combination treatment with lapatinib was not associated with an increase in either serious toxicity or rates of discontinuation related to adverse events (AEs), compared to capecitabine treatment alone. The most common AEs were diarrhea, hand-foot syndrome and rash distinct from hand-foot syndrome.(1)

Metastatic breast cancer is the leading cause of cancer deaths in women globally, resulting in more than 400,000 deaths each year.(2) Women with HER2 positive breast cancer are at a greater risk of disease progression and death compared to those women with tumors that do not over-express HER2.(3) Metastatic breast cancer eventually develops resistance to trastuzumab.(4,5)

"We are extremely enthusiastic that NEJM has chosen to publish this important data which we believe will truly change the treatment paradigm for thousands of women suffering from late stage breast cancer," said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Centre at GSK. "It is also exciting news that these results suggest there may be a role for Tykerb in the earlier treatment of breast cancer," he added.

To access the full manuscript, beginning December 28, 2006th, please visit: http://www.NEJM.org and click on "Current Issue."

About Lapatinib

Lapatinib is a small molecule dual receptor tyrosine kinase inhibitor discovered and developed by GSK as an oral once daily therapy, and is currently being investigated in breast cancer and other solid tumors. Lapatinib inhibits both the tyrosine kinase components of EGFR (ErbB1) and HER2 (ErbB2) receptors. Stimulation of these receptors is associated with cell proliferation and multiple processes involved in tumor progression, invasion, and metastases. Over-expression of these receptors has been reported in a variety of human tumors and is associated with poor prognosis and reduced overall survival.

GSK is using advanced technologies, including pharmacogenomics, to better define patient populations that may respond to Tykerb.

Regulatory Status of Lapatinib

Lapatinib has been submitted for marketing approval in the United States, European Union and Switzerland for the treatment of advanced or metastatic HER2 (ErbB2) positive breast cancer in women who have progressed despite prior therapy, including trastuzumab. Registration dossiers have also been filed in Australia, Canada and New Zealand. By the end of 2006, GSK aims to have also filed lapatinib in a number of countries in Asia, Latin America and Middle East.

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 http://www.gsk.com.

Notes to editors

Tykerb(R) 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.

Xeloda(R) is a registered trademark of Roche Pharmaceuticals.

    To access the latest GSK Oncology media materials, visit

http://www.gskcancermedia.com


    Enquiries

    GSK US Media enquiries:      Danielle Halstrom     +1 919 483 2839

                                 Melissa Maughan       +1 202 835 7290



    References:

(1) Geyer C, Forster J, Lindquist D, Chan S, Romieu C et al. Lapatinib plus capecitabine compared with capecitabine alone for HER2-positive advanced breast cancer. New England Journal of Medicine, 2006 355: 2733-2743

(2) Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005;55:74-108.

(3) Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 1987;235:177-82.

(4) Tripathy D, Slamon DJ, Cobleigh M, et al. Safety of treatment of metastatic breast cancer with trastuzumab beyond disease progression. J Clin Oncol 2004;22:1063-70

(5) Montemurro F, Donadio M, Clavarezza M, et al. Outcome of patients with HER2-positive advanced breast cancer progressing during trastuzumab-based therapy. Oncologist 2006;11:318-24.

CONTACT: Danielle Halstrom of GlaxoSmithKline, +1-919-483-2839; or MelissaMaughan, +1-202-835-7290, for GlaxoSmithKline

Web site: http://www.gsk.com/http://www.gskcancermedia.com/http://www.NEJM.org/

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Posted: December 2006

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