Boehringer broadens afatinib studies

Boehringer Ingelheim is expanding the scope of its studies into afatinib to test its use against head and neck cancers.

The new Phase III head and neck trial will be split into two studies: LUX-Head & Neck 1, whose primary endpoint is to see whether afatinib prolongs progression-free survival in patients with recurrent or metastatic forms of the disease who progress after platinum-based treatment.

The second study will look at whether afatinib prevents recurrence and improves survival in those with locally advanced disease after chemoradiotherapy. Both trials will also assess the drug’s effect on overall survival. 

Each year, around 560,000 cases of head and neck cancer are diagnosed worldwide, with 300,000 patients dying from the disease.

Dr Ezra Cohen, associate professor of medicine at the University of Chicago Medical Center, said: “Currently, approximately 50% of patients with locally advanced head and neck cancer will have a recurrence and there is an urgent need for more treatment options.” 

Merck Serono’s Erbitux (cetuximab) is already licensed to treat advanced and metastatic squamous cell carcinoma of the head and neck. 

Boehringer recently had a boost from its Phase II study that showed afatinib had comparable anti-tumour activity to Merck’s drug, in patients with metastatic head and neck cancer whose cancer had returned after chemotherapy. 

The drug is one of the most advanced cancer drugs in Boehringer’s pipeline, and is also being studied in late-stage studies for non-small cell lung cancer (NSCLC) and breast cancer, after the failure of other treatments.

Adam Hill