Comparison of Osimertinib versus Almonertinib in T790M+ EGFR Non-Small-Cell Lung Cancer Patients

What is Known and Objective. Almonertinib was newly approved for treating non-small-cell lung cancer (NSCLC) patients with EGFR T790M mutation, and the therapeutic effect of almonertinib needed to be investigated. This study aims to investigate the efficacy and safety of almonertinib compared with osimertinib in EGFR-T790M+ patients who used earlier-generation EGFR-TKI and experienced disease progression. Methods. Among all 160 patients, 80 received osimertinib, while the other 80 patients took almonertinib once daily. The objective response rate (ORR) and disease control rate (DCR) were analyzed, while overall survival (OS) and progression-free survival (PFS) were estimated. In terms of safety, adverse events (AEs) were compared. Results and Discussions. The ORR and DCR were significantly higher in patients who received almonertinib than those in the osimertinib group (70.0% vs. 47.5%, P = 0.004 ; 90.0% vs. 77.5%, P = 0.032 ). The OS was significantly higher in the almonertinib group than in patients who received osimertinib ( P = 0.031 ), while the PFS was similar between the two groups ( P = 0.226 ). Of 28 patients with brain metastasis, the OS was not raised after using almonertinib compared with the osimertinib group ( P = 0.626 ). The number of AEs was similar between the almonertinib and osimertinib groups (all P > 0.05 ). Treatment-related AEs of grade ≥3 occurred in 20.0% and 15.0% of patients in the osimertinib and almonertinib arms, respectively. What is New and Conclusion. Almonertinib may become an alternative option for EGFR-T790M + NSCLC patients after earlier-generation EGFR-TKI for its promising efficacy and manageable tolerability. However, the treatment option for patients with brain metastasis remains to be explored further.