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

PR58049

INGELHEIM, Germany, Sep. 27 /PRN-KYODO JBN/ --

    Results from the LUX-Head & Neck 1 study show afatinib* significantly

delayed tumour growth versus chemotherapy in patients following failure of

their previous treatment, reducing the risk for disease progression by 20

percent.

    Head and neck cancer has a very poor prognosis with no well-defined

standard of care after failure of previous therapy

    Data are encouraging for the ongoing pivotal LUX-Head & Neck clinical trial

programme investigating afatinib in different settings of 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 percent

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 percent vs. 38.5

percent), 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 percent vs. 5.6 percent). 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 percent) and diarrhoea (9.4 percent) with afatinib, and

leukopenia (15.6 percent) and stomatitis (8.1 percent) with chemotherapy. The

most common side effects in patients treated with afatinib compared to

chemotherapy were rash/acne (74.4 percent vs. 8.1 percent), diarrhoea (72.2

percent vs. 11.9 percent) and paronychia (nail infection) (14.4 percent vs. 0

percent), and with chemotherapy compared to afatinib were stomatitis (43.1

percent vs. 39.1 percent), fatigue (31.9 percent vs. 24.7 percent) and nausea

(22.5 percent vs. 20.0 percent). 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