Breakthrough Tx Status Granted for Mutation-positive NSCLC
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.
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.
For more information call (800) 542-6257 or visit Boehringer-ingelheim.com.