Boehringer Ingelheim GmbH

Data Suggests Promising Overall Survival and Progression-Free Survival With VARGATEF(TM) (BIBF 1120)

Ingelheim, Germany (ots/PRNewswire) - - For non-US Healthcare Media

- Abstract # 163O. von Pawel. Proffered Papers 6 - Advanced NSCLC

- Latest Phase II Data for Boehringer Ingelheim's New Cancer Drug in Development Presented

Monotherapy treatment with the triple angiokinase inhibitor(1) BIBF 1120 (planned tradename VARGATEF(TM)) offers promising efficacy and is well tolerated in patients with advanced, relapsed non-small cell lung cancer (NSCLC), according to results from a phase II study in patients with lung cancer(2). Of particular note were results from a subset of 57 patients with 'good disease state' (ECOG performance status* of 0 or 1): these patients experienced longer overall survival (median overall survival was 9.5 months), longer progression-free survival (PFS; median PFS was 2.9 months) and a higher stable disease rate of 59% compared with the overall study population. The results were presented today by Dr Joachim von Pawel from Asklepios Fachkliniken München-Gauting, Germany, at the 1st European Lung Cancer Conference jointly organized by IASLC and ESMO in Geneva, Switzerland.

BIBF 1120, administered as a capsule taken twice daily, is currently being developed by Boehringer Ingelheim and is one of the company's most advanced molecules within the cancer development portfolio. BIBF 1120 is a novel triple angiokinase inhibitor that simultaneously inhibits vascular endothelial growth factor receptors (VEGFRs), platelet-derived growth factor receptors (PDGFRs) and fibroblast growth factor receptors (FGFRs)(1) - all of which are crucially involved in the formation of blood vessels.

Commenting on these results, Dr von Pawel stated in Geneva: "This study is very encouraging because it tells us that BIBF 1120 has good efficacy when administered on its own. The substantial clinical effect observed in the subset of 57 patients with 'good' performance status (ECOG 0-1) is very notable and gives us great impetus to continue fully exploring the potential of this molecule." BIBF 1120 was also well tolerated by patients in this study, which is a very important consideration for cancer patients and their physicians. "The most important clinical question for us to address now is how much benefit patients may derive from BIBF 1120 treatment and the place this potential medicine may have in the cancer clinic of the future," he added.

Study design and results

This phase II study investigated the efficacy of BIBF 1120 in 73 patients with an ECOG score of 0-2 with locally advanced or metastatic NSCLC (stage 11B/IV)(2). Patients with all histologies were eligible to enrol. All patients in the study had previously received at least one line of platinum- based therapy. The primary endpoints were PFS and objective tumour response (measured by RECIST criteria). Secondary endpoints included overall survival (OS) and safety. Patients were randomized to receive either BIBF 1120 250 mg capsule twice daily (n=36) or 150 mg capsule twice daily (n=37). Results reported were:

All patients, ECOG 0-2 (n=73):

    - Median PFS was 1.7 months in the overall study population, which
      included 16 patients with ECOG PS 2. Nearly one in two patients (48%)
      experienced disease control (defined as Partial Response [PR] +
      Complete Response [CR] + Stable Disease [SD]). There was no difference
      in efficacy between the two dose treatment arms.
    - Median OS of all patients was 5.5 months. 

ECOG performance status 0 or 1 (n=57):

BIBF 1120 showed a substantial clinical effect in the subset of 57 patients with 'good' performance status (ECOG 0-1):

    - Median PFS was 2.9 months and disease control rate was 59%; there was
      no difference between both treatment arms.
    - Median OS in this group was 9.5 months. 

The study authors reported that BIBF 1120 administered orally twice daily was generally well tolerated. The most frequent adverse events reported in this study were nausea, diarrhoea and vomiting, and they were mostly mild to moderate.

Dr Andreas Barner, Vice Chairman of the Board of Managing Directors at Boehringer Ingelheim, commented: "These new BIBF 1120 phase II data, coupled with evidence from previous studies(3,4) that show BIBF 1120 is well tolerated in combination with standard lung cancer treatments, gives us great confidence in moving forward with further investigations of BIBF 1120 in lung cancer. We are pleased to report we are making great progress in our oncology research programme and we look forward to presenting further data from our franchise during 2008."

About BIBF 1120

BIBF 1120 is a novel triple angiokinase inhibitor that simultaneously inhibits vascular endothelial growth factor receptors (VEGFRs), platelet-derived growth factor receptors (PDGFRs) and fibroblast growth factor receptors (FGFRs)(1). These growth factors and receptors play an important role in angiogenesis; their inhibition plays a critical role in the prevention of tumour growth and spread.

To date, more than 400 patients have been treated with BIBF 1120 through enrolment in phase I and phase II clinical trials. In two phase I studies(3,4), the dose for BIBF 1120 in combination with pemetrexed or carboplatin/paclitaxel has been determined to be 200 mg twice daily. BIBF 1120 was well tolerated by patients in both studies.

About ECOG

    Grade Eastern Cooperative Oncology Group (ECOG) performance status
    0     Fully active, able to carry on all pre-disease performance without
          restriction
    1     Restricted in physically strenuous activity but ambulatory and
          able to carry out work of a light or sedentary nature, e.g., light
          house work, office work
    2     Ambulatory and capable of all self-care but unable to carry out
          any work activities. Up and about more than 50% of waking hours
    3     Capable of only limited self-care, confined to bed or chair more
          than 50% of waking hours
    4     Completely disabled. Cannot carry on any self-care. Totally
          confined to bed or chair
    5     Dead 

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.

Boehringer Ingelheim is committed to discovering and developing novel cancer treatments that have the potential to provide significant clinical and quality of life benefits for patients. 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. BIBW 2992 (a signal transduction inhibitor) is now entering phase III clinical development and phase III development for BIBF 1120 (a triple angiokinase inhibitor) is planned for 2008. In the area of cell-cycle kinase inhibition, Boehringer Ingelheim is developing novel, potent and highly selective inhibitors of polo-like kinase 1 (Plk1), a protein that is involved in the processes of cell division. These molecules are in the early stages of clinical development.

Boehringer Ingelheim is working in close collaboration with the international scientific community and a number of the world's leading cancer centres to research and develop these potential new treatments for cancer.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 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.

In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

For more information please visit http://www.boehringer-ingelheim.com

Please be advised

This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the USA.

References

* ECOG Definition: The Eastern Cooperative Oncology Group performance status are scales and criteria used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living activities of the patient, and determine appropriate treatment and prognosis.

1. Hilberg F et al. Eur J Cancer Suppl. 2004;2:50.

2. von Pawel J et al. Efficacy, Safety And Pharmacokinetic (PK) Results Of A Phase II Study With The Triple Angiokinase Inhibitor BIBF 1120 In Patients Suffering From Advanced Non-Small Cell Lung Cancer (NSCLC). Abstract # 163O. von Pawel. Proffered Papers 6 - Advanced NSCLC (parallel session)

3. Hanna N et al. A Phase I study of continuous oral treatment with the triple angiokinase inhibitor BIBF 1120 together with pemetrexed in previously treated patients with NSCLC. Abstract P3-091. Presented at WCLC, 5 September 2007.

4. Camidge R et al. A Phase I study of continuous oral treatment with the triple angiokinase inhibitor BIBF 1120 together with carboplatin and paclitaxel in patients with advanced NSCLC. Abstract P3-138. Presented at WCLC, 5 September 2007.

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Contact:

Contact: Julia Meyer-Kleinmann, Science & Technology Communications, 
Boehringer Ingelheim GmbH, Tel.: +49-6132-77-8271, Email:
press@boehringer-ingelheim.com
Original-Content von: Boehringer Ingelheim GmbH, übermittelt durch news aktuell

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