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.
