Boehringer Ingelheim's afatinib Achieves Primary Endpoint in Global Phase III Study in Recurrent/Metastatic Head and Neck Squamous Cell Cancer

          - For Ex-US and Ex-UK Media Only

          Boehringer Ingelheim today announced Phase III data from the LUX-Head & Neck 1 [http://clinicaltrials.gov/show/NCT01345682 ] study evaluating the efficacy and safety of afatinib in patients with recurrent and/or metastatic (R/M) head and neck squamous cell cancer (HNSCC) versus methotrexate (a chemotherapy). The results of this global trial, with 483 patients from 19 countries, showed that afatinib, a once-daily, irreversible ErbB blocker, is the first tyrosine kinase inhibitor (TKI) to significantly delay tumour growth versus chemotherapy in patients with head and neck squamous cell cancer after failure of previous therapy. Results of this late-breaking abstract (abstract #LBA29) will be presented today at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain (September 26-30).

          LUX-Head & Neck 1 met its primary endpoint of progression-free survival (PFS: length of time before the tumour starts to progress) by showing that patients taking afatinib, after failure of previous platinum-based chemotherapy, experienced a significant delay in tumour growth of 2.6 months versus 1.7 months with chemotherapy. This translated into a 20% reduction in risk of disease progression. With regard to secondary endpoints, afatinib significantly improved the disease control rate (DCR: the percentage of patients whose tumour size was stable or reduced, 49.1% vs. 38.5%), and the objective response rate (ORR: percentage of patients who achieved a partial or complete response to therapy) was numerically higher with afatinib compared to chemotherapy (10.2% vs. 5.6%). No significant difference between afatinib and chemotherapy was observed regarding overall survival (median 6.8 vs. 6.0 months).

          In quality-of-life questionnaires, patients taking afatinib reported significantly less pain and a delay in time to worsening of symptoms including pain, swallowing and global health status (overall health and quality of life), when compared to chemotherapy.

          Professor Jan Vermorken, M.D., Department of Medical Oncology, Antwerp University Hospital, Belgium, commented: "Afatinib achieved the primary endpoint, in showing an improved progression-free survival in a global Phase III trial versus standard chemotherapy. In addition, there were some favourable patient reported outcomes with respect to pain, swallowing and global health status when compared to standard chemotherapy. These data provide additional insight into evaluating this agent in this difficult-to-treat disease."

          The most frequent drug-related severe adverse events (> grade 3) were rash/acne (9.7%) and diarrhoea (9.4%) with afatinib, and leukopenia (15.6%) and stomatitis (8.1%) with chemotherapy. The most common side effects in patients treated with afatinib compared to chemotherapy were rash/acne (74.4% vs. 8.1%), diarrhoea (72.2% vs. 11.9%) and paronychia (nail infection) (14.4% vs. 0%), and with chemotherapy compared to afatinib were stomatitis (43.1% vs. 39.1%), fatigue (31.9% vs. 24.7%) and nausea (22.5% vs. 20.0%).​ There were fewer drug-related dose reductions and discontinuations for patients taking afatinib compared to chemotherapy. See abstract #LBA29 (Afatinib versus methotrexate as second-line treatment for patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who progressed after platinum-based therapy: results of the randomised, open-label, phase III trial LUX-Head & Neck 1, 27.09.2014, 09:15 - 10:45, Bilbao) for full details.

          Professor Gerd Stehle, Vice President, Medicine Therapeutic Area Oncology, Boehringer Ingelheim commented: "Boehringer Ingelheim is committed to helping patients with devastating diseases and to exploring new treatment options. We are pleased to be presenting these data which, further to the established efficacy of afatinib in distinct types of non-small cell lung cancer, now demonstrate the broadening clinical potential of afatinib. This is very encouraging for our ongoing LUX-Head & Neck clinical trial programme."

          Please click on the link below for 'Notes to Editors' and 'References':

          http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/27_september_2014_oncologyhn1.html

          *Afatinib (GIOTRIF(R)/GILOTRIF(R)) is indicated for the treatment of distinct types of EGFR mutation-positive NSCLC. In this indication, afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF(R) and in the U.S. under the brand name GILOTRIF(R). It is under regulatory review in other countries. Afatinib is not approved in other indications.

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          Source: Boehringer Ingelheim