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Boehringer Ingelheim to present new data at ASCO annual meeting regarding its investigational compound afatinib in EGFR-mutation positive patients with advanced NSCLC
Date:5/25/2011

Boehringer Ingelheim is committed to studying afatinib in patients with advanced NSCLC with EGFR mutations, in addition to other patient populations."

About the Afatinib Data to be Presented at 2011 ASCO Annual Meeting

This phase Ib study involved 26 EGFR-mutation positive patients with NSCLC who acquired resistance to a reversible EGFR TKI (erlotinib or gefitinib), potentially due to the emergence of a second mutation called T790M.  The T790M mutation is found in roughly 50 percent of the tumors from patients who develop acquired resistance to reversible EGFR TKIs.(2)  Patients in the study received afatinib 40 mg daily with escalating dose cohorts of bi-weekly cetuximab at 250 and 500 mg/m2.  Tumor tissue was collected at or after the emergence of acquired resistance for genetic testing.(1)

Twenty-two of the 26 patients in the study received the pre-defined maximum dose of afatinib 40 mg daily plus cetuximab 500 mg/m2.  The most common drug-related adverse events were Grade 1/2 rash (35% and 46%, respectively) and Grade 1/2 diarrhea (50% and 19%, respectively).  Three patients (11.5%) experienced Grade 3 rash.  In addition to the disease control rates observed, confirmed partial responses were seen in 36 percent (8/22) of evaluable patients (95% confidence interval [CI]: 0.17–0.59), including 29 percent of patients (4/13) who were found to have the T790M mutation.  Updated data will be available during the poster presentation at ASCO.  The study has since been expanded to enroll 80 patients; results will be presented at a future conference.(1)  

Boehringer Ingelheim will also present data at the ASCO annual meeting from several additional studies evaluating afatinib in patients with NSCLC, brain metastases and glioblastoma, and other advanced solid tumors.

About the ASCO Provisional Clinical Opinion and NCCN Clinical Practice Guidelines

Based on the growing
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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