Boehringer Ingelheim's third generation EGFR TKI, BI 1482694, receives FDA Breakthrough Therapy Designation for treatment of patients with NSCLC

FDA designation reinforces potential for BI 1482694 to become a new treatment option for patients with EGFR mutation-positive lung cancer with a T790M mutation.

"Boehringer Ingelheim is pleased that the FDA has granted Breakthrough Therapy Designation to our investigational third-generation EGFR inhibitor BI 1482694. We feel this designation reflects the potential of the compound to be an important part of the treatment of non-small cell lung cancer in patients with T790M mutation," said Tarek Sahmoud, vice president, Oncology Clinical Development and Medical Affairs. "The continued development of BI 1482694 and our entire oncology portfolio underscores our commitment to advancing novel treatment approaches designed to help improve the lives of people with cancer."

BI 1482694 is a novel, third-generation, oral EGFR mutant-selective TKI developed to specifically target tumours with T790M mutations. 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 have previously received EGFR TKI therapy.

Results from HM-EMSI-101, a Phase I/II clinical trial of BI 1482694, provide additional evidence of the strong efficacy signals and favorable safety profile of BI 1482694 at the recommended Phase II dose of 800 mg once daily. These data were recently presented at the ESMO Asia 2015 Congress in Singapore and ASCO 2015 in Chicago.