Boehringer Ingelheim initiates efficacy and safety of BI 1482694

Boehringer Ingelheim announced at the BIO-Europe® conference in Munich, Germany, the initiation of a global Phase II trial evaluating the efficacy and safety of BI 1482694 (HM61713) in patients with T790M mutation-positive non-small cell lung cancer (NSCLC), whose tumours stopped responding to currently available epidermal growth factor receptor (EGFR) directed therapies. The primary endpoint of this trial, which is the first in a broad clinical development programme for BI 1482694, is objective response rate (ORR). 

BI 1482694 is a novel, third-generation, oral, irreversible EGFR mutant-specific tyrosine kinase inhibitor (TKI) developed to specifically target tumours with T790M mutations. At this year’s American Society of Clinical Oncology (ASCO) Annual Meeting, interim results of the Phase I/II clinical trial indicated strong efficacy signals in patients with such tumours, combined with a favourable safety profile.¹ The T790M mutation is known as the most common resistance mechanism to develop in response to treatment with EGFR TKIs. It is found in approximately 50-60% of patients who previously received EGFR TKI therapy. There are currently no EGFR-directed therapies approved specifically for the treatment of this mutation, representing an area of great unmet need for these patients.