Phase 3 trial of first-line aumolertinib versus gefitinib for advanced NSCLC with EGFR ex19del or L858R alterations

Aumolertinib (formerly almonertinib; HS-10296) is a novel third-generation EGFR-TKI. The phase 3 AENEAS trial at 53 centers in China compared first-line aumolertinib versus gefitinib for locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletion or L858R mutations. The median progression-free survival was 19.3 months with aumolertinib versus 9.9 months with gefinitib (HR 0.46; p<0.0001). There were no significant differences between the two group in ORR or DCR, but the duration of response was longer with aumolertinib than with gefitinib (median 18.1 months versus 8.3 months). Adverse events of grade 3 or higher were seen in 36.4% and 35.8% of patients with aumolertinib and gefitinib, respectively. The authors conclude that aumolertinib is a well-tolerated third-generation EGFR TKI that could serve as a first-line treatment option for EGFR-mutant NSCLC.