Hansoh Pharma's Aumolertinib (Almonertinib) Phase III AENEAS Study Published in Journal of Clinical Oncology, Demonstrating Superior Efficacy and Safety as First-Line Treatment for EGFR-Mutated NSCLC

China Economic Net, May 19 (Reporter Zhu Guowang) - On May 18, the internationally renowned oncology journal, Journal of Clinical Oncology (JCO, IF: 44.544), published online a research paper on Hansoh Pharma's innovative drug Almonertinib Mesylate Tablets (brand name: Amelie) from the AENEAS study led by Professor Lu Shun from Shanghai Chest Hospital affiliated with Shanghai Jiao Tong University. This marks the first time that ASCO's official journal has published clinical data on a China-developed third-generation EGFR-TKI.

The AENEAS study is a multi-center, randomized, double-blind, controlled Phase III trial comparing Aumolertinib with Gefitinib as a first-line treatment for patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). More than 400 subjects participated in the study. The results demonstrated the superior safety and efficacy of Aumolertinib as a first-line treatment for EGFR mutation-positive locally advanced or metastatic NSCLC.

AENEAS Study is a Phase III, multicenter, randomized, double-blind, controlled trial comparing Aumolertinib (Almonertinib) with Gefitinib as a first-line treatment for patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), with over 400 participants in total. The study results demonstrated the superior safety and efficacy of Aumolertinib as a first-line treatment for EGFR mutation-positive locally advanced or metastatic NSCLC.

Compared with the existing first-line standard treatment drug Gefitinib, patients using Aumolertinib as first-line treatment showed a significantly prolonged progression-free survival (PFS) (median PFS 19.3 months VS 9.9 months) and a significantly extended duration of response (DoR) (median DoR 18.1 months VS 8.3 months), demonstrating the evident efficacy of Aumolertinib.

In all subgroup populations, the median PFS benefit of Aumetinib was superior to that of Gefitinib: 20.8 months VS 12.3 months in the 19del subgroup, 13.4 months VS 8.3 months in the L858R subgroup; the PFS benefit in the brain metastasis subgroup was particularly prominent, at 15.3 months VS 8.2 months, reducing the risk of disease progression or death by 62%. In contrast, the non-brain metastasis subgroup showed 19.3 months VS 12.6 months, suggesting that Aumetinib treatment can bring greater benefits to patients with brain metastases.

In terms of safety, compared with the gefitinib group, the amivantamab group had a longer treatment duration (median exposure time 463.5 days VS 254.0 days), but the incidence of rash, diarrhea, AST/ALT elevation, and treatment-related serious adverse events was lower, suggesting that amivantamab has a safety advantage as a first-line treatment.

This study enrolled all Chinese patients and is the first randomized controlled trial of a third-generation EGFR-TKI drug for first-line treatment in Chinese lung cancer patients, providing higher-level evidence that better reflects the disease status of Chinese lung cancer patients. In December 2021, this indication was approved by the National Medical Products Administration, becoming the second indication for Ameile (Almonertinib), ushering in a new era of first-line treatment with a China-originated third-generation EGFR-TKI. Previously, the AENEAS study presented its progress for the first time at the 2021 ASCO Annual Meeting, drawing widespread attention from international peers. The latest findings on its brain metastasis subgroup will be further released at the 2022 ASCO Annual Meeting.

Almonertinib is the first China-originated third-generation EGFR-TKI independently developed by Hansoh Pharma, and also the world's first third-generation EGFR-TKI with a median progression-free survival (mPFS) of over one year (for second-line use). Since its market launch two years ago, it has been widely used in clinical practice, benefiting more than 100,000 patients with NSCLC. Lü Aifeng, Executive Director of Hansoh Pharmaceutical Group Company Limited, stated: "The publication of Almonertinib Phase III clinical research data in JCO reflects the high recognition from the international oncology community, marking a significant breakthrough for China's pharmaceutical innovation in the field of targeted lung cancer treatment. As a leading innovation-driven pharmaceutical company in China, Hansoh Pharma will continue to accelerate the pace of technological innovation, bringing more benefits to patients in China and even globally through technological advancements."