GSK Initiates First Global Phase III Study of TYKERB(R) (lapatinib) in Head and Neck Cancer
2/26/2007 Barcelona, Spain press release PRNewswire (www.prnewswire.com) GlaxoSmithKline (GSK) today 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 announcement coincided with the International Meeting on Innovative Approaches in Head & Neck Oncology, Barcelona, Spain, February 22-24 supported by the European Society for Therapeutic Radiology and Oncology (ESTRO), where GSK presented results from a Phase I study of lapatinib in SCCHN. Lapatinib is an investigational drug that is not yet approved for marketing by any regulatory body. This large adjuvant trial will compare the effectiveness of oral lapatinib versus placebo given in high-risk patients following surgery. SCCHN is the sixth most common cancer worldwide (1): 600,000 people are diagnosed with SCCHN annually (1), 40,000 in the United States (2) and 100,800 in Europe alone.(3) 40,000 people die from the disease every year.(3) The design of this Phase III trial was based on recent results from two large-scale, independent randomized studies which have established the addition of chemotherapy to radiation therapy as the new standard of care in the post-operative treatment of high-risk SCCHN patients with additional use of chemotherapy.(4, 5) However, research suggests that approximately one quarter to one third of advanced head and neck cancers that are primarily treated with surgery and radiation therapy come back following treatment.(4, 5) "The initiation of this trial represents another exciting step towards understanding the role of lapatinib in other tumor types beyond breast cancer," says [...]