Value through Innovation24 April 2014
29 August 2011

Boehringer Ingelheim Broadens its Breast Cancer Trial Programme for Afatinib*

Two phase II studies investigating afatinib* in erbB2 (HER2)-overexpressing, metastatic or inflammatory breast cancer are open for recruitment

Ingelheim, Germany, 29 August, 2011 – Boehringer Ingelheim today announced the initiation of two phase II studies, 1200.89 and LUX-Breast 2, evaluating afatinib* in patients with metastatic breast cancer, who have an overexpression of the erbB2 (HER2) protein, so called HER2-positive patients. Afatinib* is an irreversible ErbB Family Blocker, which binds to all erbB-family kinases including erbB2 (HER2).1

The 1200.89 study is investigating the efficacy and safety of afatinib* for the treatment of patients with erbB2 (HER2)-overexpressing inflammatory breast cancer, one of the most aggressive forms of breast cancer.

The LUX-Breast 2 study, which started enrolling patients in May this year, is investigating the efficacy and safety of afatinib* in patients with erbB2 (HER2)-positive, metastatic breast cancer. The patients have progressed on currently available erbB2 (HER2) targeted treatments. 

Afatinib* is also currently being investigated in a pivotal phase III clinical trial, called LUX-Breast 1. LUX-Breast 1 is a global trial in patients with metastatic erbB2 (HER2)-positive breast cancer after prior treatment with trastuzumab. The trial investigates whether treatment with afatinib* can extend the lives of these women before their cancer progresses (progression-free survival) as compared to continuing treatment with trastuzumab when both are added to the standard chemotherapy treatment vinorelbine. Both, the LUX-Breast 1 and study 1200.89 include thorough biomarker testing of tumour tissues.

Approximately 20-30% of women with breast cancer overexpress the erbB2 (HER2) receptor. 2 This overexpression of the erbB2 (HER2) protein is associated with a more aggressive form of breast cancer and a greater risk of disease progression and death compared to women with erbB2 (HER2) negative tumours.3

Prof. Dr Nadia Harbeck

Prof. Dr Nadia Harbeck

“There is an urgent need for more treatment options for patients with aggressive erbB2 (HER2)-positive breast cancer. These studies are important because they will help us to further explore the potential of the novel compound afatinib to fill this gap in this difficult to treat group of patients”, said Professor Nadia Harbeck, Director of the Interdisciplinary Breast Centre, University Hospitals Cologne, Germany.

The initiation of these new studies represents yet another important milestone for Boehringer Ingelheim to broaden and further develop its oncology pipeline across a range of different cancers.

For more information:
About study 1200.75, LUX-Breast 1: Afatinib* in HER2-positive Metastatic Breast Cancer After One Prior Trastuzumab Treatment

http://clinicaltrials.gov/ct2/show/NCT01125566?term=LUX-Breast+1&rank=1

About study 1200.89: Afatinib* in erbB2 (HER2)-overexpressing Inflammatory Breast Cancer

http://clinicaltrials.gov/ct2/show/NCT01325428?term=afatinib+1200.89&rank=1

If investigators are interested in becoming involved in the study and have potentially eligible patients, they should contact Boehringer Ingelheim at:

clintriage.rdg@boehringer-ingelheim.com  

Notes to editors
About study LUX-Breast 1 (1200.75): Afatinib* in HER2-positive Metastatic Breast Cancer After One Prior Trastuzumab Treatment

http://clinicaltrials.gov/ct2/show/NCT01125566?term=LUX-Breast+1&rank=1

LUX-Breast 1 is an open-label, randomised phase III trial to investigate the efficacy and safety of oral afatinib* plus vinorelbine compared to trastuzumab plus vinorelbine in patients with metastatic erbB2 (HER2)-positive breast cancer who received one prior treatment with trastuzumab. The primary endpoint of this study is progression-free survival (PFS), defined as the time from the date of randomisation to the date of disease progression, or to the date of death. Secondary endpoints include best RECIST assessment during each treatment period, overall survival (OS), tumour shrinkage, time to deterioration, health-related quality of life and safety.

Inclusion criteria are as follows:

  • Histologically confirmed diagnosis of erbB2 (HER2)-overexpression breast cancer
  • Stage IV metastatic disease
  • Must have progressed on one prior trastuzumab treatment
  • No more than one prior trastuzumab based therapy regimen (either adjuvant or first-line)
  • Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer
  • Must have (archived) tumour tissue sample available for central re-assessment of erbB2 (HER2)-status

About study LUX-Breast 2 (1200.98): Afatinib* in HER2-Treatment Failures

http://clinicaltrials.gov/ct2/show/NCT01271725?term=afatinib+1200.98&rank=1

This non-randomised, open label study started in May 2011 and will recruit approximately 120 patients. The primary endpoint of the study is objective response. Secondary endpoints include best overall response (OR) during each treatment period, duration of OR, PFS and safety.

Inclusion criteria are as follows:

  • Female patients >18 years with proven diagnosis of erbB2 (HER2)-overexpressing, histologically confirmed breast cance
  • Stage IV metastatic disease
  • At least one measurable lesion according to RECIST 1.1. Skin, bone and brain lesions are considered non-target lesions
  • Must have failed or progressed on either trastuzumab or lapatanib or trastuzumab and lapatanib treatment in the neoadjuvant and/or adjuvant setting

About study 1200.89: Afatinib* in erbB2 (HER2)-overexpressing Inflammatory Breast Cancer

http://clinicaltrials.gov/ct2/show/NCT01325428?term=afatinib+1200.89&rank=1

This non-randomised, open label study is now open for recruitment of about 40 patients. The primary endpoint of the study is clinical benefit assessed by complete response, partial response and stable disease for at least 6 months. Secondary endpoints include overall response (OR), duration of OR, PFS and safety.

Inclusion criteria are as follows:

  • Female patients >18 years with proven diagnosis of erbB2 (HER2)-overexpressing, histologically confirmed breast cancer
  • Locally advanced or metastatic disease
  • Must have disease that can be evaluated according to RECIST 1.1
  • For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment
  • Investigator-confirmed diagnosis of Inflammatory Breast Cancer
  • Must have biopsiable disease

Advancing Boehringer Ingelheim’s oncology pipeline:
In addition to breast cancer, afatinib* is also being investigated for non-small cell lung cancer (NSCLC) in phase III clinical trials, the most common type of cancer.4 In the LUX-Lung clinical trial programme, one of the pivotal trials, LUX-Lung 3, evaluates the efficacy and safety of afatinib* compared to standard chemotherapy (cisplatin/pemetrexed) as a potential first-line treatment of patients with locally advanced or metastatic NSCLC with ErbB1(EGFR) mutations.
Afatinib* is just one of Boehringer Ingelheim’s most advanced oncology pipeline compounds. Another compound in Phase III development is BIBF 1120*, which is being investigated in NSCLC and ovarian cancer.

About Metastatic Breast Cancer
Metastatic breast cancer refers to the stage of the disease when cancer cells have broken away from the primary breast cancer site and spread to other parts of the body via the bloodstream or lymphatic system. Breast cancer is the most frequently diagnosed cancer and is the leading cause of cancer deaths among women worldwide, resulting in more than 450,000 deaths per year.5 Whilst mortality rates from breast cancer have decreased steadily in recent years thanks to advances in both early detection and adjuvant treatment, metastatic breast cancer still has a poor prognosis with a 5-year relative survival rate of about 23%.6

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 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 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 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. Afatinib* is currently in phase III clinical development in NSCLC. The LUME-Lung 1 phase III clinical trial is investigating BIBF 1120* in combination with standard second-line chemotherapy for patients with advanced NSCLC. 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.
More than 400 employees around the world are dedicated to the discovery and development of new cancer treatments: 200 highly skilled and motivated scientists in Vienna, Austria at the dedicated, state-of-the-art Boehringer Ingelheim cancer research centre and more than 200 across the globe associated with oncology research and development.

Boehringer Ingelheim is committed to the clinical development of pioneering treatments for cancer through an extensive and diverse global study programme involving investigators and patients from around the world. This is supported by a significant financial investment from Boehringer Ingelheim, with the aim of developing treatments, which will make a difference to the lives of patients and their families. Boehringer Ingelheim’s oncology pipeline is evolving and demonstrates the company’s continued commitment to 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 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.

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 2010, Boehringer Ingelheim posted net sales of about 12.6 billion Euro while spending almost 24% of net sales in its largest business segment Prescription Medicines on research and development.


For more information please visit: www.thewhiteroom.info/lux-breast

*
Afatinib is an investigational compound. Its safety and efficacy have not yet been fully established

Afatinib and BIBF 1120 are investigational compounds. Their safety and efficacy have not yet been fully established

Afatinib, BIBF 1120 and volasertib are investigational compounds. Their safety and efficacy have not yet been fully established

Referenzen

1 BI data on file
2 Penault-Llorca F et al. (2005) ‘Incidence and implications of HER2 and hormonal receptor overexpression in newly diagnosed metastatic breast cancer (MBC) Journal of Clinical Oncology vol.23 S69
3 Slamon D et al. (1987) ‘Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene’, Science, vol. 235, pp. 177-87
4 Metro G and Crinò (2011) ‘The LUX-Lung clinical trial program of afatinib for non-small-cell lung cancer.’ Expert Rev Anticancer Ther. vol.11 S673
5 Ferlay J et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010; EPub Ahead of print.
6 Howlader N et al. SEER Cancer Statistics Review, 1975-2008, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2008/, based on November 2010 SEER data submission, posted to the SEER web site, 2011.

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  • Dr. Christina Janista
    Boehringer Ingelheim

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    Dr Christina Janista
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    GERMANY

    • Phone + 49 - 6132 – 77 93640
    • Fax + 49 - 6132 – 77 6601
    • vCard

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Prof. Dr Nadia Harbeck

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