Single-center phase 2 trial of first-line aumolertinib plus chemotherapy for advanced NSCLC with EGFR ex19del or ex21 L858R

Aumolertinib (formerly almonertinib; HS-10296) is an oral, third-generation EGFR-TKI. A phase 2 trial at Tianjin Medical University Cancer Institute and Hospital (Tianjin, China) evaluated aumolertinib plus pemetrexed-carboplatin chemotherapy as first-line treatment for advanced non-small cell lung cancer with EGFR mutation (exon 19 deletion or exon 21 L858R). Among 34 included patient the median progression-free survival (primary endpoint) was 28.0 months (95% CI 18.7-36.9) while the median overall survival was not reached with median follow-up of 30 months (range 18-38). Objective response was seen in 31 patients (ORR 91.2%) and all patients had disease control (DCR 100%). The most common grade ≥ 3 treatment-related adverse event was decrease neutrophil count (64.7% of patients). The authors conclude that aumolertinib plus chemotherapy showed potential as first-line treatment for patients with EGFR-mutant aNSCLC, which deserves to be tested in randomized controlled trials.