Tyverb (GSK) disappoints in HER2 positive Breast Cancer

GSK presented results from the TEACH study to the 2011 CRTC-AACR San Antonio Breast Cancer Symposium. TEACH is a randomised, double-blind, placebo-controlled Phase III trial to evaluate the effects of Tyverb/Tykerb ( lapatinib )monotherapy when given to women who were diagnosed with HER2 positive breast cancer. The primary objective of the study was to compare disease-free survival (DFS) between women receiving lapatinib and those receiving placebo. More than 3000 women who completed neo-adjuvant or adjuvant chemotherapy, did not receive Herceptin (trastuzumab) and did not have evidence of disease were randomised to receive lapatinib or placebo for up to 12 months or until a DFS event, defined as objective disease recurrence, a second primary cancer, contralateral breast cancer or death from any cause. After a median follow up of 4 years, DFS events occurred in 13% of patients in the lapatinib arm and 17% of patients in the placebo arm of the trial (Hazard Ratio = 0.83 95% Confidence Interval, 0.70 to 1.00; stratified log-rank 2-sided p=0.053). Therefore, although an improvement in disease-free survival in favor of lapatinib was observed, this result did not meet the prespecified criteria for statistical significance.