Breakthrough Therapy Designation Granted to BI 1482694 for the Treatment of Patients with EGFR-mutat

December 21, 2015

In an important phase I/II clinical study, BI 1482694 (HM61713) reduced the size of tumors in NSCLC patients with genetic alterations in EGFR who progressed while being treated with a first-line EGFR Tyrosine Kinase (TK) inhibitor.  BI 1482694 is a 3rd-generation EGFR inhibitor, meaning it inhibits some mutant forms of EGFR including EGFR T790M-positive NSCLC, which is the most common resistance mutation to develop in patients on first-line EGFR TK inhibitors. The inhibition by the drug disrupts tumor signaling, and results in shrinkage of tumors.  In this study, a response rate of 61 percent was observed at the cutoff date for analyzing data from the study, and 46 percent had achieved a more robust confirmed response on 2 sequential scans.  At this cutoff date, the median duration of response had not yet been reached, and will be reported at a later date along with more mature and final response rate information.  This led the US Food and Drug Administration (FDA) to grant “breakthrough therapy designation” to Boehringer Ingelheim’s (BI’s) drug BI 1482694.  A global phase II trial, ELUXA 1, has been initiated to evaluate the safety and effectiveness of BI 1482694 in patients with T790M mutation-positive NSCLC whose tumors have stopped responding to other available EGFR-directed therapies.