GSK INITIATES TRIAL OF TYKERB IN HEAD AND NECK CANCER

GlaxoSmithKline (GSK) has announced the start of an international Phase III trial of its investigational cancer treatment Tykerb (lapatinib) in squamous-cell carcinoma of the head and neck (SCCHN). This large adjuvant trial will compare the effectiveness of oral lapatinib versus placebo given in high-risk patients following surgery.

The design of this Phase III trial was based on recent results from two large-scale, independent, randomized studies that have established the addition of chemotherapy to radiation therapy as the new standard of care in the postoperative treatment of high-risk SCCHN patients with additional use of chemotherapy. However, research suggests that approximately one-fourth to one-third of advanced head and neck cancers that are primarily treated with surgery and radiation therapy come back following treatment, according to GSK.

The study will enroll 680 high-risk patients with locally advanced head and neck cancer (stages II, III and IVa) who have undergone surgery. Patients will receive, within four to seven weeks after surgery, either lapatinib (1,500 mg) or placebo tablets once daily with radiotherapy and cisplatin for seven weeks. After this time, patients will continue with either lapatinib or placebo treatment for one year. The principal objective will be to investigate the length of time without disease symptoms, as well as overall survival.

Lapatinib blocks the activation of two key receptors, EGFR and HER2, associated with increased growth and development of SCCHN. Stimulation of these receptors is associated with multiple processes involved in tumor growth. An excessive presence of these receptors has been reported in a variety of human tumors and is associated with poor outcome and reduced survival.