GSK halts enrollment after Tykerb exceeds expectations in breast cancer study

UK drug major GlaxoSmithKline says that, following advice from an Independent Data Monitoring Committee, it has halted further enrollment in a Phase III clinical trial of its anticancer agent Tykerb (lapatinib ditosylate), used in combination with Roche's Xeloda (capecitabine) in the treatment of breast cancer, after interim data analysis showed that the drug produced statistically-significant results which exceeded the program's primary endpoint.

Tykerb is a small-molecule drug which inhibits the tyrosine kinase components of the ErbB1 and ErbB2 receptors, which are known to play a role in tumor progression, invasion and metastasis. Overexpression of these proteins has been reported for tumors in various forms of cancer and is associated with poor prognosis and a reduced overall survival rate. GSK added that the drug has an advantage over Genentech's Herceptin (trastuzumab) because it can be given orally.

Study compares Tykerb and capecitabine