Aumolertinib vs Gefitinib as First-Line Treatment for Patients With EFGR-Mutated NSCLC

Aumolertinib was associated with improved survival outcomes compared to gefitinib in patients with epidermal growth factor receptor (EFGR)-mutated non-small cell lung cancer (NSCLC), according to findings from a phase 3 trial.

“Given the approval of only one third-generation EGFR inhibitor, there is a standing need for another highly efficacious and well-tolerated agent to diversify the treatment armamentarium,” explained Shun Lu, MD, Department of Medical Oncology, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China, and colleagues.

The double-blind phase 3 trial randomly assigned 429 patients in a 1:1 ratio to receive once daily treatment of either aumolertinib or gefitinib, to assess the efficacy and safety of aumolertinib vs gefitinib as a first-line treatment for locally advanced or metastatic EGFR-mutated NSCLC. The primary outcome of the trial was progression-free survival (PFS).

Aumolertinib yielded significantly longer PFS vs gefitinib (hazard ratio [HR], 0.46; 95% confidence interval [CI], 0.36 to 0.60; P = .0001). The median PFS with aumolertinib compared to gefitinib was 19.3 months (95% CI, 17.8 to 20.8) and 9.9 months (95% CI, 8.3 to 12.6), respectively. Aumolertinib and geftinib yieleded similar objective response rates (73.8% and 72.1%, respectively) and disease control rates (93% and 96.7%, respectively). Aumolertinib yielded a median duration of response of 18.1 months (95% CI, 15.2 to not applicable) compared to 8.3 months (95% CI, 6.9 to 11.1) with gefitinib.

Among patients treated with aumolertinib, 36.4% experienced adverse events of grade 3 severity, compared to 35.8% of patients treated with gefitinib. Patients treated with aumoterlinib reported rash and diarrhea at rates of 23.4% and 16.4%, respectively, vs respective rates of 41.4% and 35.8% among patients treated with geftinib.

“The results suggest the possible use of aumolertinib as first-line treatment for EGFR-mutant NSCLC, particularly given the encouraging low rates of EGFR wild-type–mediated toxicity,” concluded Lu et al.

Source:                                        

Lu S, Dong X, Jian H, et al. AENEAS: A Randomized Phase III Trial of Aumolertinib Versus Gefitinib as First-Line Therapy for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With EGFR Exon 19 Deletion or L858R Mutations. Published online May 17, 2022. J Clin Oncol. 2022;JCO2102641. doi:10.1200/JCO.21.02641