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).

FOR NON-US MEDIA ONLY

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.