Abstract
ObjectiveThe sensitivity of immune checkpoint inhibitors (ICIs) as monotherapy is low in non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins). This study aims at investigating the effectiveness of the combination of ICI and chemotherapy (ICI-combined regimen) in a real-world population of NSCLC patients harboring near-loop insertions of EGFR exon 20.MethodsWe conducted a retrospective study of advanced NSCLC with EGFR ex20ins from April 2016 to March 2021 at Guangdong Provincial People's Hospital, Southern Medical University, China. A total of 126 cases of EGFR ex20ins were screened from 1610 patients with advanced NSCLC harboring EGFR mutations and 62 cases were further analyzed for different therapeutic efficacy.ResultsThe first-line ICI-combined regimen showed marked efficacy for near-loop insertions of EGFR exon 20, with an ORR of 71.4% and a mPFS of 11.5 months, compared to ORRs of 12.5% for traditional targeted therapy (P = .003) and 18.8% for chemotherapy (P = .013). The first-line mPFS of traditional EGFR-TKIs and chemotherapy were only 5.6 and 5.8 months, respectively. Similar results were observed for any-line therapy of ICI-combined regimen, with an ORR of 80%. The median progression-free survival (PFS) of any-line therapy of ICI-combined regimen was 11.5 months, which were significantly longer than that of traditional targeted therapy (4.5 months, P = .026) and chemotherapy (5.0 months, P = .013).ConclusionsICI-combined regimen may be superior compared to targeted therapy and chemotherapy for advanced NSCLC with near-loop insertions of EGFR exon 20. Further exploration is warranted to confirm the efficacy of ICI-combined regimen.