GSK BEGINS TRIAL OF TYKERB IN EARLY-STAGE BREAST CANCER

GlaxoSmithKline (GSK) has initiated an international breast cancer clinical trial, TEACH (Tykerb Evaluation After CHemotherapy). This will be the first Phase III study to investigate whether adjuvant treatment with the investigational drug Tykerb (lapatinib) will improve disease-free survival in women with early-stage HER2-positive breast cancer, including those with positive and negative node involvement. An adjuvant therapy is one that is administered in addition to primary surgical or radiation treatment to lower risk of disease progression. Approximately 3,000 women will be enrolled at more than 450 centers in more than 30 countries.

Lapatinib is a dual kinase inhibitor that potently blocks the action of both EGFR (ErbB1) and HER2 receptors within the cancer cell, which are associated with cell proliferation and tumor growth. A small-molecule tyrosine kinase inhibitor in a once-daily, oral formulation, lapatinib is currently in late-stage clinical development for the treatment of patients with advanced metastatic breast cancer and in earlier phases of investigation for treatment of a range of other solid tumors. In a Phase III study of Tykerb in combination with capecitabine in patients who have progressed on Herceptin treatment was stopped early by an independent data monitoring committee due to positive results.

The TEACH trial is designed to compare the efficacy and safety of lapatinib versus placebo in women treated for early-stage, HER2-positive breast cancer who have no clinical or radiographic evidence of disease. Participants must have completed primary adjuvant chemotherapy prior to study entry but must not have received trastuzumab. Patients will be randomized to receive lapatinib 1,500 mg or matching placebo orally administered once daily. Women will continue treatment for a maximum of 12 months or until disease recurrence, development of a second primary cancer, withdrawal from the study due to unacceptable toxicity or consent withdrawal. All women will be followed until death or until study closure. The primary efficacy endpoint for analysis is disease-free survival.