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Interim Data Announced for BIBF 1120 as Compared to bevacizumab in Combination Chemotherapy in Metastatic Colorectal Cancer
Date:9/27/2011

STOCKHOLM, Sept. 27, 2011 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced interim results from an exploratory clinical trial evaluating its investigational compound BIBF 1120 in patients with metastatic colorectal cancer (mCRC).  In this Phase I/II study of 126 patients comparing BIBF 1120 as first-line treatment to bevacizumab, both in combination with mFOLFOX6 (6th modified regimen of folinic acid [leucovorin], fluorouracil, and oxaliplatin), the progression-free survival (PFS) rate at 9 months was 63 percent (95% CI: 50%-75%) in the BIBF 1120 arm and 69% (95% CI: 53%-86%) in the bevacizumab arm.(1)  The median PFS was numerically similar between both groups at 10.6 months ([95% CI: 9.4-12.3] for the BIBF 1120 arm and [95% CI: 9.1-NA] for the bevacizumab arm).(2)

The study, presented at the Presidential Session of the 2011 European Multidisciplinary Cancer Congress in Stockholm, Sweden, also showed that the objective response rate (ORR), a measure of tumor shrinkage, was 61 percent in the BIBF 1120 arm and 54 percent in the bevacizumab arm.(1)

While both treatment arms showed similar safety profiles, a lower incidence of serious adverse events was seen in patients taking BIBF 1120 compared to those taking bevacizumab (34% vs. 54%).(2)  Adverse events (grade 3 or higher) experienced by at least 10 percent of patients in the BIBF 1120 and bevacizumab arms included neutropenia (32% vs. 24%), diarrhea (15% vs. 12%), neurotoxicity (14% vs. 10%), paresthesia (13% vs. 12%) and asthenia (11% vs. 10%).(1)  Patients receiving BIBF 1120 experienced a lower frequency of serious gastrointestinal adverse events than those receiving bevacizumab (12% vs. 29%).(2)

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

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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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