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Breast Cancer Treatment Drug Tykerb Slows Tumor Growth

Tykerb slows breast cancer but needs more study

December 28, 2006 -- Phase III data reporting that Tykerb (lapatinib ditosylate) plus Xelod is superior to capecitabine alone in women with HER2 (ErbB2) positive advanced breast cancer who had progressed following prior therapy, including Herceptin, was published today in the New England Journal of Medicine.

The study authors concluded that given its distinct mechanism of action and activity, as a small molecule dual receptor tyrosine kinase inhibitor, Tykerb should be investigated for use in the earlier treatment of HER2 (ErbB2) positive breast cancer. Tykerb 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. Tykerb 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 show combination treatment with Tykerb 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.

Metastatic breast cancer is the leading cause of cancer deaths in women globally, resulting in more than 400,000 deaths each year. 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. Metastatic breast cancer eventually develops resistance to trastuzumab.

"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.

Tykerb 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. Tykerb 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.

Posted: December 2006