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
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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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ots Originaltext: Boehringer Ingelheim
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Contact: Julia Meyer-Kleinmann, Science & Technology Communications,
Boehringer Ingelheim GmbH, Tel.: +49-6132-77-8271, Email:
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