A brand-new third-generation epidermal growth factor receptor tyrosine kinase inhibitor authorized in China is called aumolertinib (formerly known as almonertinib; HS-10296). Researchers compared the effectiveness and safety of aumolertinib vs. gefitinib as a first-line therapy for locally progressed or metastatic EGFR-mutated non-small-cell lung cancer for a double-blind phase III study.

At 53 locations around China, patients were randomly randomized to receive either gefitinib (250 mg) or aumolertinib (110 mg) once a day. According to the investigator’s evaluation, the main end objective was progression-free survival (PFS).

A total of 429 individuals with locally advanced or metastatic NSCLC who had never received therapy were included. PFS with aumolertinib was much longer than with gefitinib (hazard ratio, 0.46; 95% CI, 0.36 to 0.60; P<.0001). Gefitinib had a median PFS of 9.9 months (95% CI, 8.3 to 12.6) compared to aumolertinib’s 19.3 months (95% CI, 17.8 to 20.8). The objective response rates and disease control rates in the aumolertinib and gefitinib groups were similar (objective response rate, 73.8%, and 72.1%, respectively; disease control rate, 93.0% and 96.7%, respectively). With aumolertinib, the median time to respond was 18.1 months (95% CI, 15.2 to not applicable), compared to 8.3 months (95% CI, 6.9 to 11.1) with gefitinib. About 36.4% and 35.8% of patients in the aumolertinib and gefitinib groups had adverse events of grade≥3 severity (any cause). When compared to individuals who got gefitinib, rash and diarrhea (of any grade) were found in 41.4% & 35.8% vs. 23.4% & 16.4% of aumolertinib patients, respectively.

A well-tolerated third-generation EGFR receptor tyrosine kinase inhibitor called aumolertinib may be used as the first-line therapy for NSCLC with EGFR mutations.

Reference: ascopubs.org/doi/full/10.1200/JCO.21.02641