Value through Innovation21 April 2014
27 September 2011

BIBF 1120* in patients with metastatic colorectal cancer as effective as bevacizumab with less serious adverse events

Results from a Phase I/II study among the few to have been selected for presentation in the Presidential Session at the 2011 European Multidisciplinary Cancer Congress (EMCC).

Stockholm, Sweden, 27 September, 2011 – Patients with metastatic colorectal cancer (mCRC) receiving BIBF 1120* as first-line treatment in combination with mFOLFOX6 showed a median progression-free survival of 10.6 months which was equivalent to bevacizumab plus mFOLFOX6 in a randomised two arm phase II study enrolling a total of 126 patients. Importantly, only 34.1% of those patients taking BIBF 1120* experienced any kind of serious adverse events, versus 53.7% of those taking bevacizumab.

More detailed results from the trial are:

  • The objective response rate (ORR), a measure of tumour shrinkage, was 61.2% in the BIBF 1120* arm and 53.7% in the bevacizumab arm.
  • Patients receiving BIBF 1120* had a similar progression-free survival rate at 9 months to those taking bevacizumab (63% vs. 69%).
  • Importantly, patients on BIBF 1120* experienced a lower frequency of serious gastrointestinal adverse events than those receiving bevacizumab (11.8% vs. 29.3%).

The study is ongoing in order to collect overall survival data. Phase III trials with larger patient populations will be considered to confirm these positive results and to further investigate the potential of BIBF 1120* in mCRC.

Unlike other angiokinase inhibitors which only target one receptor, BIBF 1120* is a novel triple angiokinase inhibitor that blocks three growth factor receptors simultaneously (VEGFR 1-3, PDGFR alpha and beta and FGFR 1-3).1 All three receptor types play a critical role in the formation and maintenance of new blood vessels (angiogenesis).Their blockade may lead to the inhibition of angiogenesis, and may ultimately stop tumour growth and spread.2,3

“These new study results hold promise for further investigation of BIBF 1120* in patients suffering from advanced colorectal carcinoma,” said Prof Eric Van Cutsem, lead investigator for the trial, and Professor of Internal Medicine at the University of Leuven, Belgium. “It is utterly important to provide therapeutic options to our patients with less serious treatment complications, which is particularly significant as these patients have advanced disease. I would very much look forward to seeing further results to confirm the potential of BIBF 1120* in this patient population.”

BIBF 1120* has also demonstrated potential in other cancer types, and is currently in phase III development in lung and ovarian cancer.

Notes to editors

Abstract presentation details
Abstract title: LATE BREAKING ABSTRACT: A Phase I/II, Open-label, Randomised Study of BIBF 1120* Plus mFOLFOX6 Compared to Bevacizumab Plus mFOLFOX6 in Patients with Metastatic Colorectal Cancer
Abstract number: 14LBA
Speaker LBA: Van Cutsem, E. (B)
Session being presented: Presidential Session IV: Best and Late Breaking Abstracts
Location: Hall A1
Date: 27-Sep-2011
Time: 09:00-11:00

About Trial Nr. NCT 00904839
The primary objective of this Phase I/II study was to evaluate progression free survival (PFS) rate at 9 months of patients receiving BIBF 1120 in combination with mFOLFOX6 compared to patients receiving bevacizumab combined with mFOLFOX6 in first line metastatic colorectal cancer. PFS rate was defined as the percentage of patients whose disease did not progress 9 months after the treatment had started.

About Colorectal Cancer
Colorectal cancer is the second most common cause of death from cancer across all cancer types in men and women in Europe4, and is the third most commonly reported cancer in the world, with over one million cases occurring annually.5

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’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. BIBF 1120* is currently in phase III clinical development in NSCLC and further solid cancer types. Afatinib* is currently in phase III clinical development in NSCLC and breast 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.

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.

References

1 Hilberg F et al. BIBF1120: Triple angiokinase inhibitor with sustained receptor blockade and good anti-tumor efficacy. Cancer Research 2008;68(12): 4774-4782.
2 Folkman N. Clinical Applications of Research on Angiogenesis. New England Journal of Medicine 1995;333: 1757-1763.
3 Ellis, L.M. and Hicklin, D.J. VEGF-targeted therapy: mechanisms of anti-tumour activity. Nature Reviews Cancer 2008;8: 579-591.
4 Ferlay J et al. Estimates of cancer incidence and mortality in Europe in 2008. Int J Cancer 2010;46: 765-781.
5 Ferlay J et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010; EPub Ahead of print.

* BIBF 1120 is an investigational compound. Its 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.

Media contact

  • Specht
    Boehringer Ingelheim

    Corporate Communications

    Dr Heike Specht
    Binger Strasse 173

    55216 Ingelheim

    GERMANY

Media contact

  • Specht
    Boehringer Ingelheim

    Corporate Communications

    Dr Heike Specht
    Binger Strasse 173

    55216 Ingelheim

    GERMANY

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