A retrospective study of the efficacy and safety of Almonertinib in the treatment of locally advanced or brain metastatic non-small cell lung cancer with EGFR-positive mutations

Abstract Objective: To retrospectively analyze the efficacy and safety of Almonertinib in locally advanced or brain metastatic non-small cell lung cancer（NSCLC）with EGFR-positive mutations. Patients and Methods: Patients with advanced NSCLC initially diagnosed with brain metastases (BMs) or progression of BMs were recruited into this study, and treated with Almonertinib.The patients were divided into two groups, Almonertinib mono-therapy group and combined group of Almonertinib and radiotherapy(RT).The primary endpoint were intracranial objective response rate (ORR) and intracranial disease control rate (DCR). The secondary endpoints included PFS and OS. Results: 162 patients were included in our study, in which 86 patients in the Almonertinib mono-therapy group and 76 patients in thecombined therapy group. At the end of follow-up, 40 patients died with a data maturity of 24.7%. The median follow-up was 18 months. The ORR and DCR of intracranial lesions were observed in 83 of 162 (51.2%) and 155 of 162 (95.6%). The ORR and DCR of extra-cranial lesions were observed in 67 of 162 (42.9%) and 143 of 162 (91.6%). The overall population ORR and DCR were observed in 82 of 162 (50.6%) and 150 of 162 (92.5%). The median PFS in this group was 15.0 months, and the 1- and 2-year PFS rates were 59.7% and 36.4%, respectively. The 1-year PFS rates for Almonertinib plus RT and mono-therapy were 53.5% and 65.7%, respectively. Conclusions: Almonertinib mono-therapy is a safe and effective treatment for patients with locally advanced or metastatic NSCLC with EGFR-positive mutation.