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

Ingelheim, Germany (ots/PRNewswire) -

- 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%
- 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% 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_relea
ses/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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ots Originaltext: Boehringer Ingelheim GmbH
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