INGELHEIM, Germany - Monday, January 12th 2015 [ME NewsWire]
Results
from two large trials independently showed a significant improvement in
the secondary endpoint of overall survival for the subgroup of patients
with the most common EGFR mutation (Del19)
Patients with the Del19
mutation who received first-line afatinib compared to standard
chemotherapy lived more than one year longer, achieving a 41% reduction
in the risk of death
Del19 is the most common EGFR mutation in lung cancer accounting for approximately 50% of all EGFR mutations
LUX-Lung
3 and LUX-Lung 6 both met their primary endpoint of progression-free
survival as afatinib significantly delayed tumour growth compared to
standard chemotherapy regimens in patients with EGFR mutation-positive
NSCLC
For media outside the UK, US and Canada only
(BUSINESS WIRE)
- Boehringer Ingelheim today announced overall survival (OS) results
were published in The Lancet Oncology from two independent Phase III
clinical trials (LUX-Lung 3 and LUX-Lung 6) in epidermal growth factor
receptor (EGFR) mutation-positive patients with metastatic non-small
cell lung cancer (NSCLC). In each trial, patients whose tumours have the
most common EGFR mutation (deletion in exon 19; Del19) lived more than
one year longer when treated with first-line afatinib, an irreversible
ErbB Family Blocker, compared to standard chemotherapy. Overall survival
was a secondary endpoint. Afatinib is the first and only EGFR targeting
agent to demonstrate an overall survival benefit compared to
chemotherapy in the first-line treatment of NSCLC patients with EGFR
mutations.
“The positive overall survival results seen with afatinib
in these two trials are an encouraging development for NSCLC patients
with Del19 mutated tumours. No other currently existing EGFR targeted
therapy has demonstrated an overall survival benefit in lung cancer
patients with any type of EGFR mutation,” said Professor James Chih-Hsin
Yang, Director of the Cancer Research Center, College of Medicine,
National Taiwan University, Taipei, Taiwan. “These data further add to
the body of evidence for afatinib which has previously demonstrated
improvements in progression-free survival, lung cancer symptom control
and quality of life in both Del19 and L858R populations, compared to
chemotherapy.”
Results from both trials showed similar overall
survival in the afatinib and chemotherapy arms in the overall NSCLC EGFR
mutation-positive population (LUX-Lung 3: median OS 28.2 vs 28.2
months; LUX-Lung 6: median OS 23.1 vs 23.5 months), however, a
significant benefit was observed in patients with the Del19 mutation.
For these patients, both studies individually demonstrated a significant
reduction in the risk of death with first-line afatinib compared to
chemotherapy. That translated into a survival benefit of more than a
year (LUX-Lung 3: median OS 33.3 vs 21.1 months; LUX-Lung 6: median OS
31.4 vs 18.4 months).
The effect was not observed for patients with
L858R mutations, whose survival did not significantly differ between
treatment arms in each trial. Adverse events for afatinib in the
LUX-Lung 3 and 6 trials were as expected with EGFR inhibition, and were
predictable, manageable and reversible. Diarrhoea and rash/acne were the
most frequently reported side effects with afatinib therapy.
“This
is the first time a targeted agent in the first-line setting has shown
an overall survival benefit for NSCLC patients with the Del19 EGFR
mutation,” commented Professor Gerd Stehle, Vice President Medicine
Therapeutic Area Oncology, Boehringer Ingelheim. “These data are an
important scientific advancement as they clearly demonstrate that even
within the EGFR mutation-positive patient group we are dealing with
different molecular abnormalities that require a tailored treatment
approach.”
LUX-Lung 3 (Global) and LUX-Lung 6 (Asian), two of the
largest trials in this patient population, were similar in design with
the exception of the platinum-based chemotherapy comparator regimen:
pemetrexed/cisplatin in LUX-Lung 3 and gemcitabine/cisplatin in LUX-Lung
6‡. Both studies met the primary endpoint of progression-free survival
for patients whose tumours have common EGFR mutations receiving
first-line afatinib. In addition, more patients taking afatinib
experienced an improvement in lung cancer-related symptoms (cough,
shortness of breath, chest pain) and a significantly better quality of
life, when compared with chemotherapy.
--Ends--
‡In LUX-Lung 6
gemcitabine and cisplatin were used as the comparator, as this
combination is commonly used for the treatment of first-line NSCLC
patients in China, the Republic of Korea and Thailand
*Afatinib is
approved in a number of markets, including the EU, Japan, Taiwan and
Canada under the brand name GIOTRIF® and in the U.S. under the brand
name GILOTRIF® for use in patients with distinct types of EGFR
mutation-positive NSCLC. Registration conditions differ internationally,
please refer to locally approved prescribing information. Afatinib is
under regulatory review by health authorities in other countries
worldwide. Afatinib is not approved in other indications.
For more
information please visit
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/12_january_2015_oncology.html
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Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Susanne Granold
Phone: +49 6132 – 77 93319
Fax: +49 6132 – 77 6601
Email: press@boehringer-ingelheim.com
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