FDA granted Breakthrough Therapy Designation to an epidermal growth factor receptor mutant-specific tyrosine kinase inhibitor, 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 non-small cell lung cancer in patients whose tumors have stopped responding to currently available EGFR-directed therapies. These data were presented at the ESMO Asia 2015 Congress in Singapore and ASCO 2015 in Chicago.
BI 1482694 is an oral, third-generation 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, according to the drug’s sponsor, Boehringer Ingelheim.
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 patients, including 32 (46 percent) 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 included diarrhea, nausea, rash and skin itching.
A 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.
