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

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

Each year, approximately 560,000 cases of head and neck cancer are diagnosed worldwide, and 300,000 patients die annually. 4

For patients with recurrent/metastatic disease, treatment options include systemic chemotherapy. Despite the introduction of chemotherapy in this setting approximately 30 years ago, patients with recurrent/metastatic head and neck cancer still have a poor prognosis, with a median survival of only 6-10 months. 5 In locally advanced head and neck cancer, chemoradiotherapy is an important option. However, due to high recurrence rates, patients with locally advanced disease tend to also have a poor prognosis.

“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” said Dr Ezra Cohen, Associate Professor of Medicine at the University of Chicago Medical Center “We hope potential new treatments such as afatinib will increase the effective options for patients with head and neck cancer.”

LUX-Head & Neck 1 will evaluate, if afatinib* can prolong progression-free survival (primary endpoint) and improve overall survival in patients with recurrent/metastatic head and neck cancer who progress after platinum-based treatment.

LUX-Head & Neck 2 will evaluate, if afatinib* can prevent the recurrence of the disease and improve overall survival in patients with locally advanced disease after chemoradiotherapy.

The initiation of these phase III clinical trials represents yet another important milestone for Boehringer Ingelheim to broaden and further develop its oncology pipeline across a range of different cancers.

This expands the phase III clinical trial programme for Boehringer Ingelheim Oncology which currently includes trials with afatinib* in NSCLC and breast cancer and nintedanib* (BIBF 1120) in NSCLC and ovarian cancer.

If investigators are interested in becoming involved in the study and have potentially eligible patients, they should contact Boehringer Ingelheim at: [email protected]

*Afatinib, nintedanib (BIBF 1120) and volasertib are investigational compounds. Their safety and efficacy have not yet been fully established.

References

1. BI data on file
2. Ford, A.C. and Grandis, J.R., 2003. Targeting epidermal growth factor receptor in head and neck cancer. Head Neck, 25, 67-73
3. Seiwert TY, et al. THNO 2011; Rome, abstract PP3.4
4. Boyle P. et al. World Cancer Report 2008. International Agency for Research on Cancer.
5. oleman M.P et al. 2003 EUROCARE-3 summary: cancer survival in Europe at the end of the 20th century. Annals of Oncology, 14,S5, v128-v149.
6. viana P. Lutzky. D. J. et al., 2008. Biomarkers for Cancers of the Head and Neck. Clinical Medicine: Ear, Nose and Throat, 1,5-15.
7. rmanno N. et al., 2005. The ErbB receptors and their ligands in cancer: An overview. Current Drug Targets, May, 6(3), pp.243-247.
8. Bernier, J. and Cooper, J.S. 2005. Chemoradiation after Surgery for High-Risk Head and Neck Cancer Patients: How Strong Is the Evidence? The Oncologist, 10(3), pp.215-224.