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22 Dec 2015

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 has announced that FDA has granted Breakthrough Therapy Designation to its investigational third-generation epidermal growth factor receptor (EGFR) mutant-specific tyrosine kinase inhibitor (TKI), BI 1482694 (HM61713). The designation is based on results from the Phase I/II HM-EMSI-101 clinical trial evaluating the treatment of T790M mutation-positive NSCLC in patients whose tumors have stopped responding to currently available EGFR-directed therapies.

"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.

  • In patients with T790M-positive NSCLC who had previously been treated with an EGFR TKI, objective responses (ORs) by independent assessment were observed in 62% patients, including 32 (46%) patients whose tumor response had been confirmed at the time of data cut-off. Disease control rate was 91% by independent assessment. At the time of data cut off, median duration of response had not yet been reached and will be reported at a later date.

    The most common treatment-related adverse events (AEs) included (total/grade 3) diarrhea (55%/0%), nausea (37%/0%), rash (38%/5%) and skin itching: 36%/1%).

    The Global Phase II trial, ELUXA 1, has been initiated to evaluate the efficacy and safety of BI 1482694 in patients with T790M mutation-positive NSCLC whose tumors stopped responding to currently available EGFR directed therapies. The primary endpoint of this trial, which is the first in a broad clinical development program for BI 1482694, is objective response rate.

    Boehringer Ingelheim has an exclusive license and collaboration agreement with Hanmi Pharmaceutical Co. Ltd for the development and global commercialization rights of BI 1482694 (HM61713), except in South Korea, China and Hong Kong.

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