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GlaxoSmithKline has announced the start of the first late-stage trial of its investigational cancer drug lapatinib (Tykerb®) in squamous-cell carcinoma of the head and neck.
The global phase III study will enroll 680 high-risk patients with locally advanced head and neck cancer (stages II, III and IVa) who have undergone surgery, and patients will receive, within four to seven weeks of surgery, either 1,500mg of lapatinib or placebo tablets once-daily with radiotherapy and cisplatin for seven weeks. After that, patients will continue with either lapatinib or placebo for a year. GSK said the main objective would be to investigate length of time without symptoms. Overall survival and other clinical factors would also be measured.
GSK pointed out that head and neck cancer was the sixth most common cancer worldwide. Every year 600,000 patients are diagnosed – 100,000 of them in Europe – and 40,000 people die of the disease.
Principal investigator Professor Jean Bourhis, of the Institute Gustave Roussy in France, said the trial “represents another exciting step towards understanding the role of lapatinib in other tumour types beyond breast cancer”. He added: “There is a significant group of patients who are at high risk of disease recurrence following surgery, and they need new treatments that can be combined with standard chemoradiation therapy.”
The announcement coincided with the International Meeting on Innovative Approaches in Head and Neck Oncology in Barcelona, Spain, where GSK presented results from a phase I dose-escalation study of lapatinib, in which doses ranged from 500mg to 1,500mg, plus chemoradiation in 31 head and neck cancer patients. The data indicated that 1,500mg of lapatinib once daily with chemotherapy and radiotherapy was the optimal dose for this combination, so this dose was selected for the phase III study.
Additionally, 89% of patients had a tumour response to this combination treatment. The most common side-effects in the phase I study were mouth ulcers (87%), radiation skin injury (65%), nausea (61%), swallowing difficulties (52%) and vomiting (52%).
Tykerb, in combination with capecitabine, has been submitted for marketing approval in the USA, EU and Switzerland for treating advanced or metastatic HER2-positive breast cancer in women who have progressed despite prior therapy, including trastuzumab. Registration dossiers have also been filed in Australia, Canada and New Zealand.