Boehringer Ingelheim receives FDA Breakthrough Therapy Designation for 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 • Phase 1/2 data presented at ESMO Asia 2015 Congress showed 62 percent objective responses in patients treated with BI 1482694, including 32 patients (46 percent) with confirmed tumor response • New global Phase 2 trial ELUXA 1 study enrolling patients

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RIDGEFIELD, Conn.—Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (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 1/2 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, M.D., Ph.D., 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 tumors 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 to 60 percent of patients who have previously received EGFR TKI therapy.
Results from HM-EMSI-101, a Phase 1/2 clinical trial of BI 1482694, provide additional evidence of the strong efficacy signals and a favorable safety profile of BI 1482694 at the recommended Phase 2 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 percent of patients, including 32 (46 percent) of patients whose tumor response had been confirmed at the time of data cut-off. Disease control rate was 91 percent 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 percent/0 percent), nausea (37 percent/0 percent), rash (38 perent/5 precent) and skin itching: 36 percent/1 percent).
The Global Phase 2 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. There are currently several U.S. trial sites open and for more information, please visit (NCT02485652).
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.
This is a Phase 1/2, multicenter study of BI 1482694 in Korean patients. All patients included in the trial had been previously treated with at least one EGFR TKI and may have received additional lines of chemotherapy or other systemic treatments. At the recommended Phase 2 dose (RP2D: 800 mg qd), all eligible patients had to have confirmed T790M mutation in the tumor. The primary endpoint was OR; secondary endpoints included duration of response, disease control rate, progression-free survival (PFS) and safety.
ELUXA 1 is an ongoing pivotal Phase 2 global clinical trial. It is designed to further investigate the efficacy and safety of BI 1482694 in patients with NSCLC who acquired T790M-mediated resistance after first-line EGFR TKIs. The ELUXA 1 trial is part of a broad ELUXA pivotal trial program which will include the initiation of Phase 3 studies in 2016.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 146 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.
 Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and families. Company employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, you’re invited to visit the BI Corporate Social Responsibility Report.
In 2014, Boehringer Ingelheim achieved net sales of about $16.96 billion dollars (13.3 billion euros). R&D expenditure corresponds to 19.9 percent of its net sales.

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