New
data from the LUX-Lung 3 trial in first-line patients with EGFR
mutation positive NSCLC, presented at the ESMO 2012 Congress (European
Society for Medical Oncology) shows that patients benefit from
substantial improvements in lung cancer-related symptoms and have better
quality of life when treated with the irreversible ErbB Family Blocker,
afatinib*.
VIENNA - Friday, September 28th 2012 [ME NewsWire]
Poster: #1229PD
Presentation: Sunday, September 30; 12:45 – 2:45 PM CEST
Poster Discussion Session: NSCLC, metastatic
(BUSINESS WIRE)-- For NON-US media only
Data
from LUX-Lung 3, the largest and most robust registration trial to
datea in patients with EGFR (ErbB1) mutation positive non-small cell
lung cancer (NSCLC) shows that the novel compound afatinib*, an
irreversible ErbB Family Blocker, leads to better and longer control and
improvement of the most common lung cancer-related symptoms and better
quality of life (QoL) compared to chemotherapy (pemetrexed and
cisplatin), considered best-in-class for non-squamous NSCLC.1,2 These
findings further reinforce the outstanding first-line efficacy of
afatinib* in patients with EGFR mutation positive NSCLC.
Analyses
of patients’ questionnaires for three pre-specified lung cancer
symptoms (cough, dyspnoea and pain) showed that more afatinib*-treated
patients experienced significant improvements in dyspnoea (64% vs. 50%;
p=0.0103), a statistical trend towards improvement in pain (59% vs. 48%;
p=0.0513) and numerical improvements in cough (67% vs. 60%; p=0.2444)
compared to those treated with pemetrexed / cisplatin.1 Afatinib* also
significantly delayed the time to deterioration for cough (HR=0.60;
p=0.007) and dyspnoea (HR=0.68; p=0.0145) versus chemotherapy.1
Importantly, afatinib* treatment led to improved physical, role and
cognitive functioning, and overall better QoL.1
“Lung
cancer-related symptoms like fatigue, shortness of breath and pain are
very distressing and have a dramatic impact on patients’ quality of
life.” said Dr Matthew Peters, chair of The Global Lung Cancer
Coalition. “With around 90% of advanced NSCLC patients experiencing two
or more disease-related symptoms and high levels of associated
psychological distress3 it is important that we consider these endpoints
when assessing the benefits of a treatment.”
Previously
presented LUX-Lung 3 trial data has shown that patients taking
afatinib* as a first-line treatment lived for almost one year without
their tumour growing again (median progression-free survival (PFS) of
11.1 months) versus just over half a year (PFS of 6.9 months) for those
treated with pemetrexed / cisplatin.4 Furthermore, NSCLC patients with
tumours harbouring the two most common EGFR mutations taking afatinib*
lived for well over a year without tumour progression (PFS of 13.6
months) versus just over half a year (PFS of 6.9 months) for those in
the comparator arm.4 Patients with common EGFR mutations who experienced
a greater PFS benefit also experienced a greater benefit in
health-related QoL, symptom control and symptom improvement.1
“Following
encouraging data presented earlier this year, the new data demonstrate
that the positive progression-free survival outcomes with afatinib* also
translate into additional benefits for patients in terms of quality of
life and control and improvement of symptoms,” commented Dr Vera Hirsh,
Associate Professor, McGill University, Department of Medical Oncology,
Royal Victoria Hospital, Montreal, Canada. “This further supports the
potential of this treatment option in first-line treatment of metastatic
NSCLC to effectively help those patients harboring EGFR mutations.”
Afatinib*
is an irreversible ErbB Family Blocker, thus it differs from currently
available targeted therapies in that it irreversibly and completely
inhibits ErbB receptor signal transduction, blocking the key pathways
that help tumour cells grow, migrate and metabolise.5 This novel mode of
action may lead to a distinct therapeutic benefit and has provided the
basis for initiation of the LUX-Lung trial programme.5
This
years’ ESMO 2012 Congress sees the presentation of 13 abstracts
assessing the efficacy and safety of Boehringer Ingelheim’s
investigational oncology compounds afatinib* and nintedanib*.
Presentations of Boehringer Ingelheim Investigational Oncology Compounds at ESMO 2012 Congress
Title
First Author
Details
Afatinib*
LUX-Lung
3: Activity of afatinib in uncommon epidermal growth factor receptor
(EGFR) mutations in LUX-Lung 3, a phase III trial of afatinib or
cisplatin/pemetrexed in EGFR mutation-positive lung cancer
J.C.-H. Yang
1252P Date: Saturday, 29 September Time: 13:00 – 14:00 PM CEST
Phase
II trial of afatinib as a third-line treatment for Korean patients
(pts) with wild-type epidermal growth factor receptor (wtEGFR) stage
IIIB/IV lung adenocarcinoma
M.-J.A. Ahn
1292P Date: Saturday, 29 September Time: 13:00 – 14:00 PM CEST
LUX-Lung
3: Symptom and health-related quality of life results from a randomized
phase III study in 1st-line advanced NSCLC patients harbouring EGFR
mutations
L.V. Sequist
1229PD
Date: Sunday, 30 September
Time: 12:45 – 14:45 PM CEST
A
Phase I study of daily afatinib, an irreversible ErbB Family Blocker,
combined with weekly paclitaxel and 2-weekly bevacizumab in patients
with advanced solid tumours
D. Enting
464P Date: Monday, 1 October Time: 13:00 – 14:00 PM CEST
Phase
I study to compare safety and pharmacokinetics of afatinib, an oral
irreversible ErbB Family Blocker, in non-cancer subjects with hepatic
impairment to matched healthy subjects
D. Schnell
468P Date: Monday, 1 October Time: 13:00 – 14:00 PM CEST
Phase
I safety and tolerability of once daily oral afatinib (A) (BIBW 2992)
in combination with gemcitabine (G) in patients (pts) with advanced
solid tumours
S. Zanetta
478P Date: Monday, 1 October Time: 13:00 – 14:00 PM CEST
Phase
I safety and tolerability of once daily oral afatinib (A) in
combination with docetaxel (D) in patients (pts) with relapsed or
refractory advanced solid tumours
H. Senellart
494P Date: Monday, 1 October Time: 13:00 – 14:00 PM CEST
LUX-Lung
8: A randomized, open-label, Phase III trial of afatinib vs. erlotinib
in patients with advanced squamous cell carcinoma of the lung as
second-line therapy following first-line platinum-based chemotherapy
G. Goss
509TiP Date: Monday, 1 October Time: 13:00 – 14:00 PM CEST
LUX-Lung
5: Impact of EGFR mutation status on clinical benefit from BIBW 2992 in
patients (pts) with advanced non-small cell lung cancer (NSCLC)
progressing after chemotherapy (ctx) and erlotinib (E) or gefitinib (G) –
A single center experience
J. Köhler
1339 Abstract Only
Activity
of afatinib/cetuximab in patients (pts) with EGFR mutant non-small cell
lung cancer (NSCLC) and acquired resistance (AR) to EGFR inhibitors
Y.Y. Janjigian
1227O Date: Sunday, 30 September Time: 9:00 – 11:00 AM CEST
Combination Afatinib* and Nintedanib*
Phase
I study of afatinib (BIBW 2992), an ErbB Family Blocker plus nintedanib
(BIBF 1120), a triple angiokinase inhibitor, in patients (pts) with
advanced solid tumours
J.-C. Soria
446PD Date: Sunday, 30 September Time: 13:00 – 14:00 PM CEST
Nintedanib*
Phase I study of nintedanib (BIBF 1120) in European patients with advanced hepatocellular carcinoma
D. Palmer
740P Date: Sunday, 30 September Time: 13:00 – 14:00 PM CEST
Early data from a phase I study of nintedanib (BIBF 1120) in Asian patients with advanced hepatocellular carcinoma
C.-J. Yen
744P Date: Sunday, 30 September Time: 13:00 – 14:00 PM CEST
Boehringer Ingelheim Media Briefing at ESMO 2012
LUNG CANCER: what lies beneath the data
WHEN:Saturday 29 September 2012, 17:30–19:00
WHERE: Industry Press Room, Level 1, Lounge 1, ESMO2012 Congress Venue (Austria Center Vienna),Vienna, Austria
Highlights
from the session, including the webcast will also be available on
www.thewhiteroom.infofrom Monday 1 October. In the meantime, visit this
online resource centre for further information.
Notes to Editors
About Afatinib*
Afatinib*
is an irreversible ErbB Family Blocker which inhibits signal
transduction of all kinase receptors from the ErbB Family5, which 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). Afatinib* is currently also in
Phase III clinical development in breast cancer and head & neck
cancer.
The European Medicines Agency (EMA) has
recently accepted the submission of a Marketing Authorisation
Application from Boehringer Ingelheim for approval of afatinib* as a
treatment in patients with EGFR mutation positive NSCLC.
About LUX-Lung 3 Trial
LUX-Lung
3 is the largest and most robust registration trial to date in patients
with advanced EGFR mutation positive lung cancer. LUX-Lung 3 is a
global, randomized, open-label, Phase III trial and the first to
directly compare a tyrosine kinase inhibitor (afatinib*) to the standard
chemotherapy agents, pemetrexed and cisplatin. The study included 345
previously untreated patients with EGFR mutation positive NSCLC.4
The
most common drug-related adverse events observed in the afatinib*
treatment arm were diarrhoea (95%), rash/acne (89%), and
mucositis/stomatitis (72%). The most common drug-related adverse events
observed in the chemotherapy arm (pemetrexed /cisplatin) were nausea
(66%), decreased appetite (53%), and vomiting (42%). There was a low
discontinuation rate associated with treatment-related adverse events in
the trial (8% discontinuation rate for afatinib*; 12% for
chemotherapy). One percent of patients in the afatinib* arm discontinued
treatment due to diarrhoea.
About Lung Cancer
Lung
cancer is the most common and most deadly form of cancer in the world.6
In Europe, it accounts for 391,000 new cancer cases annually, and
342,000 deaths each year.7 Overall, lung cancer is the cause of 19.9% of
all cancer deaths in Europe.7 Thirteen percent of all new cases of
cancer are lung cancers8 and smoking is attributed as the main cause.9
Early
testing for tumour EGFR mutation status of lung cancer patients is
critical in improving patient outcomes. Between 10-15% of Caucasian and
40% of Asian NSCLC patients have tumours harbouring EGFR mutations, with
approximately 90% of these accounting for two mutations (del19 or
L858R).10
About Nintedanib*
Nintedanib*
is a triple angiokinase inhibitor that blocks three growth factor
receptors simultaneously: vascular endothelial growth factor receptors
(VEGFR 1-3), platelet-derived growth factor receptors (PDGFR alpha and
beta) and fibroblast growth factor receptors (FGFR 1-3).11 All three
receptors are crucially involved in the formation and maintenance of new
blood vessels (angiogenesis); their blockade may lead to the inhibition
of angiogenesis, which plays a critical role in tumour growth and
spread.12,13
Nintedanib* is currently being
investigated in patients with a number of various solid tumours
including advanced non-small cell lung cancer (NSCLC), ovarian cancer,
liver cancer (hepatic cell carcinoma), kidney cancer (renal cell
carcinoma), and colorectal cancer.
About Boehringer Ingelheim in Oncology
Building
on scientific expertise and research excellence in the fields of
pulmonary and cardiovascular medicine, metabolic disease, neurology,
virology and immunology, Boehringer Ingelheim has embarked on a major
research programme to develop innovative cancer drugs. Working in close
collaboration with the international scientific community and a number
of the world’s leading cancer centres, Boehringer Ingelheim’s commitment
to oncology is underpinned by using advances in science to develop a
range of targeted therapies for various solid tumours and haematological
cancers.
The current focus of research includes
compounds in three areas: angiogenesis inhibition, signal transduction
inhibition and cell-cycle kinase inhibition. Nintedanib*, an
angiogenesis inhibitor is currently in Phase III clinical development in
NSCLC and ovarian cancer. In the area of cell-cycle kinase inhibition,
Boehringer Ingelheim is developing an inhibitor of polo-like kinase 1
(Plk1), volasertib*, a protein that is involved in the processes of cell
division. The compound is in Phase II development for acute myeloid
leukaemia.
Boehringer Ingelheim’s oncology pipeline is
evolving and demonstrates the company’s continued commitment to advance
the disease area.
Boehringer Ingelheim
The
Boehringer Ingelheim group is one of the world’s 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it
operates globally with 145 affiliates and more than 44,000 employees.
Since it was founded in 1885, the family-owned company has been
committed to researching, developing, manufacturing and marketing novel
medications of high therapeutic value for human and veterinary medicine.
As
a central element of its culture, Boehringer Ingelheim pledges to act
socially responsible. Involvement in social projects, caring for
employees and their families, and providing equal opportunities for all
employees form the foundation of the global operations. Mutual
cooperation and respect, as well as environmental protection and
sustainability are intrinsic factors in all of Boehringer Ingelheim’s
endeavours.
In 2011, Boehringer Ingelheim achieved net
sales of about 13.2 billion euro. R&D expenditure in the
business area Prescription Medicines corresponds to 23.5% of its net
sales.
For more information please visit:
www.boehringer-ingelheim.com, www.thewhiteroom.infoand www.newshome.com
a
LUX-Lung 3 included 345 patients in 133 sites in 25 countries. Results
were independently reviewed. The chemotherapy arm was cisplatin /
pemetrexed, considered the most efficacious platinum doublet
chemotherapy in advanced and metastatic lung cancer.2 The trial
prospectively selected EGFR (ErbB1) mutations, rather than
retrospectively. The trial was the largest trial conducted in lung
cancer patients with EGFR mutations. The trial included patients from
all over the world including Caucasians and Asians.
* These are investigational compounds.
Their safety and efficacy have not yet been fully established.
References
1.
Abstract no: 1229PD. Sequist L. V. et al. LUX-Lung 3: Symptom and
health-related quality of life results from a randomized phase III study
in 1st-line advanced NSCLC patients harbouring EGFR mutations. ESMO
2012 Congress. Available at:
http://abstracts.webges.com/myitinerary/session-148.html?congress=esmo2012#.UFdGtBr1LSY.gmai
2.
Scagliotti GV, et al. Phase III study comparing cisplatin plus
gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive
patients with advanced-stage non-small-cell lung cancer.J Clin Oncol
2008;26(21):3543–51
3. Tanaka K. et al. Impact of
Dyspnea, Pain, and Fatigue on Daily Life Activities in Ambulatory
Patients with Advanced Lung Cancer. Journal of Pain and Symptom
Management. Journal of Pain and Symptom Management 2002, Vol. 23 No. 5.
4.
Abstract no: LBA7500. Yang et al. LUX-Lung 3: A randomized, open-label,
phase III study of afatinib versus pemetrexed and cisplatin as
first-line treatment for patients with advanced adenocarcinoma of the
lung harboring EGFR-activating mutations. Oral Presentation at 48th
Annual Meeting of the American Society of Clinical Oncology (ASCO) 2012.
5.
Solca, F. et al. Target Binding Properties and Cellular Activity of
Afatinib (BIBW 2992), an Irreversible ErbB Family Blocker (Fast Forward
10 August 2012) . J Pharmacol Exp Ther 2012 343 (2).
6. Ferlay J et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010; 127 2893-2917.
7. Ferlay J et al. Estimates of cancer incidence and mortality in Europe in 2008. EJC 2010; 46 765-781.
8.
Cancer Research UK. UK lung cancer incidence. CancerStats – Key Facts
2009. [Online] Available at:
http://info.cancerresearchuk.org/cancerstats/types/lung/incidence/[Last
Accessed September 2012].
9. Allen J et al. J Natl Compr Canc Netw 2008;6(3): 285-293.
10.
Quest Diagnostics – Lung Cancer Mutation Panel. [Online] Available at:
http://www.questdiagnostics.com/hcp/intguide/jsp/showintguidepage.jsp?fn=TS_LungCancerMutation_Panel.htm[Last
Accessed September 2012].
11. Hilberg F et al.
BIBF1120: Triple angiokinase inhibitor with sustained receptor blockade
and good anti-tumor efficacy. Cancer Research 2008;68(12): 4774-4782.
12. Folkman N. Clinical Applications of Research on Angiogenesis. New England Journal of Medicine 1995;333: 1757-1763
13.
Ellis, L.M. and Hicklin, D.J. VEGF-targeted therapy: mechanisms of
anti-tumour activity. Nature Reviews Cancer 2008;8: 579-591.
Contacts
Boehringer Ingelheim
Corporate Communications
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55216 Ingelheim/Germany
Phone: +49 6132 77 90815
Fax: +49 6132 77 6601
Email: press@boehringer-ingelheim.com
More information
www.boehringer-ingelheim.com
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