PIVOTAL TRIAL OF AMEILE® PLUS CHEMOTHERAPY (AENEAS2) PUBLISHED IN THE LANCET ONCOLOGY
Recently, the top international oncology journal The Lancet Oncology (Impact Factor: 33.7) published online the latest results of Hansoh Pharma’s innovative drug Ameile® (aumolertinib mesylate tablets) from the AENEAS2 study. This study is a Phase III clinical trial evaluating first-line treatment with aumolertinib (110mg) combined with platinum-based doublet chemotherapy in locally advanced or metastatic non-small cell lung cancer (NSCLC) patients harboring EGFR exon 19 deletion or exon 21 (L858R) substitution mutations. Data showed that aumolertinib combined with platinum-based doublet chemotherapy significantly improved progression-free survival (PFS) in advanced EGFR mutation-positive NSCLC patients, with overall manageable safety.
AENEAS2 is a randomized, open-label, Phase 3 study conducted at 60 centers in China, aiming to evaluate the efficacy and safety of aumolertinib combined with platinum-based doublet chemotherapy versus aumolertinib monotherapy in locally advanced or metastatic EGFR mutation-positive NSCLC. The study enrolled 624 patients with advanced EGFR mutation-positive NSCLC. Results demonstrated: Based on blinded independent central review (BICR) assessment, the combination therapy group showed significantly improved PFS compared to the monotherapy group (HR 0.47, 95% CI: 0.37–0.60; P<0.0001), reducing the risk of disease progression or death by 53%. Median PFS was 28.9 months versus 18.9 months, respectively. Overall survival (OS) data were immature but suggested a survival benefit trend for targeted-chemotherapy combination versus monotherapy (HR 0.44). In patients with measurable baseline brain lesions, the response rate reached 100% in the targeted-chemotherapy combination group. Regarding safety, the safety profile of the combination regimen was consistent with the known safety profiles of individual agents, with overall manageable safety and good tolerability. 89% of patients completed 4–6 cycles of platinum-based chemotherapy, and the median treatment duration of pemetrexed was 20 cycles.
Lung cancer is one of the malignancies with the highest global incidence and mortality rates. Although third-generation EGFR-TKIs are standard first-line treatments for advanced EGFR-mutant NSCLC, the efficacy of monotherapy is difficult to breakthrough. With escalating clinical demands, combination therapy models with targeted agents have gradually become a key direction for overcoming therapeutic challenges.
As China’s first domestically developed third-generation EGFR-TKI, Ameile® addresses the higher demands for first-line treatment in locally advanced or metastatic EGFR mutation-positive NSCLC patients, providing a new combination therapy option with both efficacy and safety advantages for Chinese patients.
About The Lancet Oncology
The Lancet Oncology is an authoritative sub-journal of the top international medical journal The Lancet, founded in 2000 by Lancet Publishing Group. With a latest impact factor of 33.7, it is a globally leading clinical oncology research journal focused on advancing clinical practice, improving current standards, advocating healthcare policy reform, and dedicated to addressing global oncology-related issues.
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative medicines that generate product sales in China, with the revenue from innovative medicines and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China, and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).
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