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Boehringer Ingelheim Broadens Its Breast Cancer Clinical Trial Program for the Investigational Compound Afatinib

RIDGEFIELD, Conn., Sept. 6, 2011 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. recently announced the initiation of two global phase II studies evaluating afatinib (BIBW 2992) in patients with inflammatory and metastatic breast cancer who have an overexpression of the erbB2 (human epidermal receptor 2 or HER2) protein, also known as HER2-positive patients. Afatinib is an investigational orally-administered irreversible inhibitor of the erbB family of receptor tyrosine kinases, specifically epidermal growth factor receptor (EGFR) and HER2.  Afatinib is in late-stage development in advanced breast cancer and non-small cell lung cancer (NSCLC).  The initiation of these studies represents another important milestone as Boehringer Ingelheim broadens and further develops its oncology pipeline across a range of different cancers.

Study 1200.89, "Afatinib (BIBW 2992) in erbB2 (HER2)-overexpressing Inflammatory Breast Cancer," recently opened for recruitment in Australia, India and the United Kingdom, and will begin enrolling U.S. patients in January 2012.  This trial will investigate the efficacy and safety of afatinib for the treatment of patients with HER2-positive inflammatory breast cancer, one of the most aggressive forms of breast cancer.  Upon progression, patients may be further evaluated with a combination of afatinib and vinorelbine.

A second global trial being conducted outside of the U.S., 1200.98 (LUX-Breast 2), "Afatinib in HER2-Treatment Failures," began enrolling patients in Asia and the United Kingdom in May 2011 and is investigating the efficacy and safety of afatinib in patients with HER2-positive, metastatic breast cancer who have progressed on currently available HER2-targeted treatments.  This trial will evaluate afatinib initially alone and subsequently after progression in combination with either vinorelbine or paclitaxel.  

Afatinib is also being investigated as a potential treatment option for HER2-positive patients with advanced breast cancer in a pivotal phase III clinical trial called LUX-Breast 1. Studies 1200.89 and LUX-Breast 1 include biomarker testing of tumor tissues.

Breast cancer is the second-leading cause of cancer death in women after lung cancer.  An estimated 39,520 American women are expected to die from breast cancer in 2011.(1)  It is thought that women overexpress the HER2 protein in approximately 30 percent of advanced breast cancer cases.(2)  

"There is a need for more treatment options for patients with aggressive HER2-positive breast cancer. These studies are important because they will help us to further explore the potential of afatinib in this difficult-to-treat group of patients," said Andree Amelsberg, M.D., Executive Director, Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. 

About the Afatinib Clinical Program

The LUX trial program is a comprehensive and robust program that comprises more than 10 trials conducted across the globe, investigating afatinib for potential approval for a variety of solid tumor types, including NSCLC, breast and head and neck cancer.  In breast cancer specifically, the following trials are underway:

Afatinib in HER2-Positive Metastatic Breast Cancer After One Prior Trastuzumab Treatment (LUX-Breast 1)

LUX-Breast 1 is a global, open-label, randomized study in nearly 800 HER2-positive patients with advanced breast cancer after prior treatment with trastuzumab. The primary endpoint of the study evaluates whether treatment with afatinib can extend the time until cancer progresses (i.e., progression-free survival or PFS) as compared to continuing treatment with trastuzumab, when both are added to the standard chemotherapy treatment vinorelbine. Overall survival and safety are among the secondary endpoints that will be assessed in the trial.  For more information, please visit

Afatinib in HER2-Treatment Failures (1200.98)

This global, non-randomized, open-label study began in May 2011 and will investigate the efficacy and safety of afatinib alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the neoadjuvant or adjuvant setting. The study will recruit approximately 120 patients.  The primary endpoint of the study is objective response rate; secondary endpoints include best overall response (OR) during each treatment period, duration of OR, PFS and safety.  For more information, please visit  

Afatinib in erbB2 (HER2)-Overexpressing Inflammatory Breast Cancer (1200.89)

This non-randomized, open-label study will investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, locally advanced or metastatic inflammatory breast cancer. The study will include approximately 40 patients (combined in the United States and globally) who have or have not failed prior trastuzumab treatment. The primary endpoint of the study is clinical benefit rate assessed by complete response, partial response and stable disease for at least six months; secondary endpoints include OR, duration of OR, PFS and safety.  For more information, please visit  U.S. investigators who are interested in becoming involved in this study and have potentially eligible patients should contact Boehringer Ingelheim at:  

About Afatinib

Afatinib is an investigational compound.  Afatinib is not approved by the FDA; its safety and efficacy have not been established.  

Afatinib is an orally-administered irreversible inhibitor of the erbB family of receptor tyrosine kinases, specifically EGFR and HER2.  In addition to breast cancer, afatinib is also in late-stage clinical development in NSCLC, the most common type of lung cancer. LUX-Lung 3 is a phase III study in patients with NSCLC and EGFR mutations, which compares single-agent afatinib with chemotherapy using cisplatin/pemetrexed as first-line treatment.

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 drugs. Working in close collaboration with the international scientific community and a number of the world's leading cancer centers, Boehringer Ingelheim is committed to discovering and developing novel cancer treatments. This commitment is underpinned by using advances in science to develop a range of targeted therapies in areas of medical need, including seven investigational compounds in different phases of development for solid tumors and hematological cancers.

The current focus of research includes compounds in three areas: angiogenesis inhibition, signal transduction inhibition and cell-cycle kinase inhibition.  Afatinib is currently in phase III clinical development in NSCLC and breast cancer.  Apart from afatinib, Boehringer Ingelheim's late-stage oncology portfolio includes BIBF 1120, an investigational orally-administered triple angiokinase inhibitor that targets three of the receptor tyrosine kinases shown to aid in the regulation of angiogenesis (formation of blood vessels): fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptor (PDGFR) and vascular endothelial growth factor receptor (VEGFR).  As angiogenesis plays a pivotal role in the growth of all solid tumors, BIBF 1120 is currently being investigated in a number of cancers including NSCLC, ovarian, hepatocellular and colorectal cancers.  BIBF 1120 is not approved by the FDA; its safety and efficacy have not been established.  

In the area of cell-cycle kinase inhibition, Boehringer Ingelheim is developing inhibitors of polo-like kinase (Plk), a protein that is involved in the processes of cell division. These molecules are in the earlier stages of clinical development.

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 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

For Boehringer Ingelheim—and its employees—carrying a good share of social responsibility is an important component in its business culture. Both global commitments in social projects and properly caring for all its employees are included. Respect, equal opportunity, and the balance of career and family life form the basis for mutual cooperation. And, environmental protection and sustainability are always the main focus during any of Boehringer Ingelheim's undertakings.

In 2010, Boehringer Ingelheim posted net sales of approximately $16.7 billion (about 12.6 billion euro) while spending almost 24% of net sales in its largest business segment, Prescription Medicines, on research and development.

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(1) American Cancer Society.  Cancer Facts and Figures: 2011.  Available at:  Last accessed August 24, 2011.
(2) Penault-Llorca, F et al.  Incidence and implications of HER2 and hormonal receptor overexpression in newly diagnosed metastatic breast cancer (MBC). J Clin Oncol. 2005 23: 764

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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