New Boehringer Ingelheim Oncology Data to be Presented at ESMO 2012 Congress
RIDGEFIELD, Conn., Sept. 20, 2012 /PRNewswire/ — Boehringer Ingelheim today announced that data from 13 abstracts assessing the efficacy and safety of two of its investigational oncology compounds – afatinib and nintedanib – were selected for presentation at the ESMO 2012 Congress (European Society for Medical Oncology) in Vienna, Austria, September 28 – October 2, 2012. These data represent Boehringer Ingelheim’s commitment to further develop its oncology pipeline with the goal of bringing new treatment options to the oncology community.
Data will include results from Phase II and III studies of afatinib in various lung cancer treatment settings and patient groups as well as data on health-related quality of life and symptom control. Data from Phase I studies of afatinib in advanced solid tumors will also be presented. The nintedanib results are from Phase I studies in hepatocellular carcinoma and in combination with afatinib in advanced solid tumors.
“Boehringer Ingelheim is looking forward to sharing new results for our investigational oncology compounds with the global oncology community at ESMO,” said Berthold Greifenberg, M.D., vice president, Clinical Development and Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. “This is an exciting time for Boehringer Ingelheim as we continue to explore the potential of our growing oncology pipeline.”
Data for Boehringer Ingelheim Investigational Oncology Compounds at ESMO 2012
Title Lead Study Author Abstract Details
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Afatinib*
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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 James Chih-Hsin Yang, ESMO Abstract # 1252P
MD, PhD Date: Saturday, September 29
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 Myung-Ju Ahn Ahn, ESMO Abstract # 1292P
MD Date: Saturday, September 29
Time: 13:00 - 14:00 PM CEST
Activity of afatinib/cetuximab
in patients (pts) with EGFR
mutant non-small cell lung
cancer (NSCLC) and acquired
resistance (AR) to EGFR
inhibitors Yelena Y. Janjigian, ESMO Abstract # 1227O
MD Date: Sunday, September 30
Time: 9:00 - 11:00 AM 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 Lecia V. Sequist, ESMO Abstract # 1229PD
MD, MPH Date: Sunday, September 30
Time: 12:45 - 14:15pm 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 Deborah Enting ESMO Abstract # 464P
Date: Monday, October 1
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 David Schnell, ESMO Abstract # 468P
MD Date: Monday, October 1
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 Sylvie Zanetta, ESMO Abstract # 478P
MD Date: Monday, October 1
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 Helene Senellart, ESMO Abstract # 494P
MD, PhD Date: Monday, October 1
Time: 13:00 - 14:00 PM CEST
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 Jens Koehler, ESMO Abstract # 1339
MD Publication Only
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 Jean-Charles Soria, ESMO Abstract # 446PD
MD, PhD Date: Sunday, September 30
Time: 13:00 - 14:00 PM CEST
--- ---------------------------
Nintedanib*
----------
Phase I study of nintedanib
(BIBF 1120) in European
patients with advanced
hepatocellular carcinoma Daniel Palmer ESMO Abstract # 740P
Date: Sunday, September 30
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 Chia-Jui Yen, ESMO Abstract # 744P
MD, PhD Date: Sunday, September 30
Time: 13:00 - 14:00 PM CEST
--- ---------------------------
*Afatinib and nintedanib are investigational compounds; their efficacy and safety have not been established.
About Boehringer Ingelheim in Oncology
Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research program to develop innovative cancer treatments. Working in close collaboration with the international scientific community and a number of the world’s leading cancer centers, Boehringer Ingelheim’s commitment to oncology is underpinned by using advances in science to develop a range of targeted therapies for various solid tumors and hematological cancers.
The current focus of late-stage research includes compounds in three areas: signal transduction inhibition, angiogenesis inhibition and cell-cycle kinase inhibition. Afatinib is an investigational orally-administered irreversible inhibitor of the ErbB family of receptor tyrosine kinases, which is currently in phase III clinical development in advanced NSCLC, head and neck cancer, and breast cancer. Boehringer Ingelheim recently submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of afatinib as a treatment for patients with EGFR (ErbB1) mutation-positive NSCLC. The company is working on applications for afatinib in a number of countries, including the United States. Nintedanib (BIBF 1120) is an investigational orally-administered triple angiokinase inhibitor that targets three of the receptor tyrosine kinases shown to aid in the regulation of angiogenesis and is currently in Phase III clinical development in NSCLC and ovarian cancer. Volasertib is an investigational inhibitor of polo-like kinase that is currently being investigated in early phase trials. Boehringer Ingelheim’s oncology pipeline continues to evolve and demonstrates the company’s continued commitment to the disease area.
For information about participating in a Boehringer Ingelheim clinical trial, please visit www.bicancertrials.com or call 1.866.725.7110. Healthcare providers interested in learning more about Boehringer Ingelheim clinical trials in oncology can visit www.inoncologyus.com for additional information.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
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 has a demonstrated commitment to corporate social responsibility. 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 endeavors.
In 2011, Boehringer Ingelheim achieved net sales of about $17.1 billion (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 http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.
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