Kim DW, et al. - Among patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who had failed ≥ 1 previous line of EGFR-tyrosine kinase inhibitor (TKI) therapy, researchers tested olmutinib for its safety, tolerability, pharmacokinetics and antitumor activity in this phase 1/2 study. Dose-escalation and four dose-expansion parts were involved in the phase 1 (1: olmutinib 300 mg once daily; 2A: 800 mg once daily [EGFR T790 M mutation-positive patients]; 2B: 500 mg twice daily [EGFR T790 M mutation-positive]; 3: 800 mg once daily [EGFR T790 M mutation-negative]). Olmutinib 800 mg once daily was administered to EGFR T790 M mutation-positive patients in phase 2. Diarrhea (59.2% of patients), pruritus (42.1%), rash (40.8%), and nausea (39.5%) were documented as the most frequent treatment-related adverse events that occurred. Findings revealed effective clinical activity as well as a manageable safety profile of olmutinib in these patients, suggesting its curative potential for T790M-positive NSCLC patients who have failed ≥ 1 previous line of EGFR-TKI therapy.