Aumolertinib Combined with Platinum-Based Chemotherapy Demonstrates Significant PFS Benefit in First-Line EGFR-Mutated NSCLC: AENEAS2 Phase III Trial Published in The Lancet Oncology

Recently, the international top-tier oncology journal The Lancet Oncology (Impact Factor: 33.7) prominently published online the latest results of the AENEAS2 study on Hansoh Pharma’s innovative drug Almonertinib (Almonertinib Mesylate Tablets). This study is a Phase III clinical trial evaluating first-line treatment with almonertinib (110 mg) in combination with platinum-based doublet chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. The data demonstrated that almonertinib combined with platinum-based doublet chemotherapy significantly improved progression-free survival (PFS) in patients with advanced NSCLC carrying EGFR-sensitive mutations, with an overall manageable safety profile.

AENEAS2 is a randomized, open-label, phase III study conducted at 60 centers in China, designed to evaluate the efficacy and safety of almonertinib combined with platinum-based doublet chemotherapy versus almonertinib monotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR-sensitive mutations.

The study included a total of 624 patients with advanced non-small cell lung cancer (NSCLC) harboring EGFR-sensitive mutations. The results showed that, based on assessments by an independent blinded review committee (BICR), the combination therapy group demonstrated a significant improvement in progression-free survival (PFS) compared to the monotherapy group, with a 53% reduction in the risk of disease progression or death. The median PFS was 28.9 months versus 18.9 months, respectively. Overall survival (OS) data were immature but indicated a trend toward a survival benefit with the targeted therapy combination compared to monotherapy. In patients with measurable brain lesions at baseline, the response rate in the targeted therapy combination group reached 100%. Regarding safety, the safety profile of the combination regimen was consistent with the known safety profiles of the individual agents. The overall safety was manageable and well tolerated, with 89% of patients completing 4–6 cycles of platinum-based chemotherapy, and the median number of pemetrexed treatment cycles was 20 months.

Lung cancer is one of the malignant tumors with the highest incidence and mortality rates worldwide. Although third-generation EGFR-TKIs are the standard first-line treatment for advanced EGFR-mutated NSCLC, the efficacy of monotherapy remains constrained by inherent limitations. With the continuous escalation of clinical demands, combination therapies involving targeted drugs have gradually emerged as a key exploratory direction to overcome this therapeutic bottleneck.

As China’s first domestically developed third-generation EGFR-TKI, Ameile addresses the unmet needs in first-line treatment for patients with locally advanced or metastatic NSCLC harboring EGFR-sensitive mutations, offering Chinese patients a novel combination therapy option with superior efficacy and safety.