LANDMARK PHASE III TYKERB DATA PUBLISHED IN NEJM

Data from a Phase III study reporting that Tykerb (lapatinib) plus Xeloda (capecitabine) is superior to capecitabine alone in women with HER2-positive advanced breast cancer who had progressed following prior therapy, including Herceptin (trastuzumab), were published in the New England Journal of Medicine.

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-positive breast cancer. Lapatinib is an investigational medicinal product and has not been approved for marketing by any regulatory body.

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.

Lapatinib is a small molecule dual receptor tyrosine kinase inhibitor discovered and developed by GlaxoSmithKline 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 and HER2 receptors. Stimulation of these receptors is associated with cell proliferation and multiple processes involved intumorprogression, invasion, and metastases. Over-expression of these receptors has been reported in a variety of humantumorsand is associated with poor prognosis and reduced overall survival.