Boehringer Ingelheim Pharmaceuticals, Inc. will present new phase Ib data at the 2011 American Society of Clinical Oncology (ASCO) annual meeting in Chicago (June 3-7) that indicates combining its investigational therapy afatinib (BIBW 2992) with cetuximab at the maximum tested dose controlled disease in all (n=22) treated epidermal growth factor receptor (EGFR)-mutation positive patients with non-small cell lung cancer (NSCLC) who developed acquired resistance to treatment with a reversible EGFR tyrosine kinase inhibitor (TKI). Researchers observed a tumor size reduction of up to 76 percent over a treatment period of up to five months. The most common drug-related adverse events were rash and diarrhea, with three patients (11.5%) experiencing Grade 3 rash. Afatinib is an orally-administered irreversible inhibitor of the erbB family of receptor tyrosine kinases, specifically EGFR and HER2. It is in late-stage development in advanced NSCLC and breast cancer.
Boehringer Ingelheim and QIAGEN are pleased that ASCO and the National Comprehensive Cancer Network (NCCN), two leading oncology organizations, recently recommended EGFR mutation testing for patients with metastatic or recurrent NSCLC. These recommendations underscore the importance of genetic tumor testing to predict patient response to certain treatments, enabling personalized healthcare. Boehringer Ingelheim has partnered with QIAGEN to develop a real-time polymerase chain reaction assay (real-time PCR) companion diagnostic test for afatinib that, if approved, could help physicians identify which patients may benefit from EGFR-targeted therapies.
"The ASCO and NCCN EGFR mutation testing recommendations reinforce the importance of identifying the appropriate NSCLC patients for clinical trials," said Christopher Corsico, M.D., M.P.H., Senior Vice President, Medicine and Regulatory, Boehringer Ingelheim Pharmaceuticals, Inc. "Boehringer Ingelheim is committed to studying afatinib in patients with advanced NSCLC with EGFR mutations, in addition to other patient populations."
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