AZD9291 for EGFR-Inhibitor–Resistant Non–Small-Cell Lung Cancer

AZD9291 is an oral, irreversible third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets mutated EGFR while sparing the wild-type EGFR. AZD9291 has activity in non–small-cell lung cancer (NSCLC) against the known T790M resistance mutation, which is often acquired after disease progression on earlier-generation EGFR TKIs.

Now, investigators have conducted an industry-supported phase I study to test the safety and effectiveness of AZD9219 in 253 patients with advanced mutated-EGFR NSCLC in whom resistance to EGFR TKIs had developed. Of these, 31 were included in the dose-escalation (from 20 to 240 mg once daily) portion of the study, and 222 were included in 5 dose-expansion cohorts, for which cent…