GSK presents phase lll data for lapatinib at San Antonio breast cancer symposium

Improvement in disease-free survival does not reach statistical significance in study of delayed adjuvant therapy with lapatinib (Tykerb or Tyverb) monotherapy in HER2 positive breast cancer. End Quote

(1888PressRelease) December 09, 2011 - Results from TEACH (Tykerb Evaluation After Chemotherapy) were presented today at 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 lapatinib monotherapy when given to women who were diagnosed with HER2 positive breast cancer, received treatment excluding trastuzumab, and remained disease free. The median time from diagnosis to study entry was 3 years. Use of lapatinib in the delayed adjuvant setting is investigational only and not approved by regulatory authorities anywhere in the world.

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 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.

Serious adverse events were reported in 6% of the lapatinib arm and 5% of the placebo arm. The rate of Grade 3 diarrhoea was 6% in the lapatinib arm and

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