GSK initiates Ph III trial of Tykerb

UK drug major GlaxoSmithKline has initiated a Phase III trial of its investigational cancer treatment Tykerb (lapatinib) in squamous cell carcinoma of the head and neck (SCCHN).

Analysts have predicted annual sales of the drug at about L1.0 billion ($1.96 billion) mainly from use against breast cancer, but also from brain and kidney cancers, which are important as approximately 30% of breast cancer spreads to the brain. This global, Phase III study will enroll 680 high-risk patients with locally-advanced SCCHN (stages II, III and IVa) that have undergone surgery. Patients will receive, within four to seven weeks after surgery, either Tykerb (1,500mg) or placebo tablets once-daily with radiotherapy and cisplatin for seven weeks. After this time, patients will continue with either Tykerb or placebo for one year. The principal objective will be to investigate the length of time without disease symptoms and overall survival, though other clinical factors will also be measured.