GSK starts phase III Tykerb trial

GlaxoSmithKline (GSK) has announced the initiation of an international phase III clinical study of Tykerb (lapatinib) as a treatment for squamous cell carcinoma of the head and neck (SCCHN).

The company made the announcement of this adjuvant trial investigating the efficacy of lapatinib with placebo in patients following surgery after the International Meeting on Innovative Approaches in Head & Nech Oncology held in Spain last week.

Lapatinib is an orally-administered once-daily treatment, discovered and developed by GSK that is currently being investigated for uses as a therapy for solid tumours, including breast cancer.

In the phase III trial, 680 high-risk patients that have undergone surgery for locally advanced head and neck cancer will be administered with 1500 mg of lapatinib or placebo in addition to radiotherapy and cisplatin once-daily for a seven-week break.

Paolo Paoletti, senior vice president of the oncology medicine development centre at GSK, said: “Having already shown promise as a breast cancer treatment, we are very excited to continue investigating lapatinib in SCCHN.”

He added that the compound could provide a new approach to the treatment of head and neck cancer, in addition to other hard-to-treat tumour types.

Last month, GSK announced the start of a study comparing the immunogencity of Cervarix, its cervical cancer vaccine, with Gardasil, a vaccine from Merck, Sharp and Dohme.