Drug is potential challenge to ImClone, Bristol-Myers Squibb and Merck Serono’s Erbitux
Boehringer Ingelheim has started two phase III clinical trials of afatinib in head and neck cancer.
The studies will evaluate the drug in patients with metastatic and recurrent head and neck cancer, and in patients with locally advanced disease.
They follow positive phase II results, which compared afatinib to ImClone, Bristol-Myers Squibb and Merck Serono's Erbitux (cetuximab).
“Currently, approximately 50 per cent of patients with locally advanced head and neck cancer will have a recurrence and there is an urgent need for more treatment options” said Dr Ezra Cohen, associate professor of medicine at the University of Chicago Medical Center, who will be part of the research team.
“We hope potential new treatments such as afatinib will increase the effective options for patients with head and neck cancer.”
The move expands the clinical trial programme for the drug, which is currently being investigated for use in the treatment of non-small cell lung cancer (NSCLC).
However, in a phase II/III study in NSCLC afatinib did not achieve the primary endpoint of extending survival, even though the drug was associated with objective improvements.
These included delayed disease progression and improvements in cancer-related symptoms in a population which currently has no other treatment option.
The drug is a next generation tyrosine kinase inhibitor, which targets the epidermal growth factor receptor (EGFR) and the human epidermal growth factor receptor 2 (HER2).
Mutations affecting EGFR expression can lead to tumour growth, with the aim of EGFR inhibitors to control this expression.
Currently approved therapies targeting EGFR are Roche's Tarceva (erlotinib) and AstraZeneca's Iressa (gefitinib) as well as Erbitux, which won US approval in advanced head and neck cancer in November. However, many patients develop resistance to these treatments.
Afatinib and Pfizer's dacomitinib, which is in phase II trials for head and neck cancer, are aiming to provide alternative treatment options.