The FDA has granted Breakthrough Therapy designation to BI 1482694 (HM61713; Boehringer Ingelheim). BI 1482694 is for the treatment of T790M mutation-positive NSCLC in patients whose tumors have stopped responding to currently available EGFR-directed therapies.

The Breakthrough Therapy designation is based on results from HM-EMSI-101, a multicenter, Phase 1/2 clinical trial of BI 1482694 in Korean patients with T790M mutation-positive NSCLC. The subjects had previously been treated with ≥1 EGFR TKI and may have received other chemotherapy or systemic treatments. The primary endpoint was objective response (OR) by independent assessment.

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Results from the study showed that ORs were observed for BI 1482694 in 62% of patients with T790M-positive NSCLC who had previously been treated with an EGFR TKI, including 32 (46%) patients with confirmed tumor response at data cut-off period. Findings were recently presented at the ESMO Asia 2015 Congress in Singapore and ASCO 2015 in Chicago.

BI 1482694 is currently being evaluated in a global Phase 2 clinical trial, ELUXA 1, to further assess its efficacy and safety for the same indication. Phase 3 studies are intended to initiate in 2016.

BI 1482694 is a novel, third-generation, oral EGFR mutant-specific tyrosine kinase inhibitor (TKI) selectively targeting tumors with T790M mutations.

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