Boehringer Ingelheim initiates pivotal programme for novel third-generation EGFR targeting lung cancer compound

05-Nov-2015 - Germany

Boehringer Ingelheim announced 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).

Coordinating investigator Professor Keunchil Park, Division of Hematology & Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, South Korea commented, “Third-generation EGFR TKIs, which were developed to overcome the most frequent resistance mechanism to available first- and second-generation compounds, could become an important addition to our armamentarium against EGFR-mutant lung cancer. In this patient population with T790M we are now able to investigate a follow-on targeted therapy and potentially further delay the use of burdensome chemotherapy regimens.”

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.

https://www.bionity.com/en/news/155404/boehringer-ingelheim-initiates-pivotal-programme-for-novel-third-generation-egfr-targeting-lung-cancer-compound.html