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New Boehringer Ingelheim Corporation Oncology Data to be Presented at ESMO 2012 Congress



9/20/2012 11:06:49 AM

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

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

James Chih-Hsin Yang,

MD, PhD

ESMO Abstract # 1252P
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,

MD

ESMO Abstract # 1292P
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,

MD

ESMO Abstract # 1227O
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,

MD, MPH

ESMO Abstract # 1229PD

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,

MD

ESMO Abstract # 468P
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,

MD

ESMO Abstract # 478P
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,

MD, PhD

ESMO Abstract # 494P
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,

MD

ESMO Abstract # 1339
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,

MD, PhD

ESMO Abstract # 446PD
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,

MD, PhD

ESMO Abstract # 744P
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.

SOURCE Boehringer Ingelheim


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