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Boehringer Ingelheim Moves into Phase III for its Head and Neck Cancer Trial Programme for Afatinib*

Two studies investigating afatinib* in patients with locally advanced or recurrent/metastatic head and neck cancer are open for recruitment. - FOR NON-US MEDIA ONLY

Ingelheim, Germany, 26 January 2012 โ€“ Boehringer Ingelheim announced today the initiation of two phase III clinical trials, LUX-Head & Neck 1 and LUX-Head & Neck 2. These trials evaluate afatinib* in patients with metastatic and recurrent head and neck cancer, and in patients with locally advanced disease, respectively.

Afatinib* is an irreversible ErbB Family Blocker which inhibits signal transduction of all kinase receptors from the ErbB Family, and is known to play a critical role in the growth and spread of the most pervasive cancers and cancers associated with high mortality (lung, breast, and head & neck cancers). Over-expression of the Epidermal Growth Factor Receptor (EGFR, also referred to as ErbB1) 1 is found in at least 90% of head and neck cancers and strongly correlates with poor prognosis and overall survival. 2

Positive results from a recently presented phase II study show that afatinib* is the first targeted therapy with at least comparable anti-tumour activity to cetuximab in patients with metastatic head and neck cancer whose cancer has returned (recurrent disease) after treatment with platinum-based chemotherapy. 3