Hansoh Pharma's Innovative Drug Ameile (Aumolertinib) Receives Grade I Recommendation in 2025 CSCO NSCLC Guidelines for Consolidation Therapy in EGFR-Mutant Stage III Unresectable NSCLC

Recently, the "2025 CSCO Diagnosis and Treatment Guidelines Conference," jointly hosted by the Chinese Society of Clinical Oncology (CSCO) and the Beijing Xisike Clinical Oncology Research Foundation, released the "CSCO Guidelines for the Diagnosis and Treatment of Primary Non-Small Cell Lung Cancer (2025 Edition)." Hansoh Pharma's original innovative drug, Almonertinib Mesylate Tablets (brand name: Amelie), received a Level Ⅰ recommendation as consolidation therapy following chemoradiotherapy for EGFR mutation-positive Stage Ⅲ unresectable non-small cell lung cancer (NSCLC) patients. This makes it the first China-developed third-generation EGFR-TKI to achieve this level of recommendation.

The latest recommendation is mainly based on the positive results of Amelie in the POLESTAR study. This is a nationwide, multi-center, randomized, double-blind, controlled, Phase III clinical study aimed at evaluating the efficacy and safety of Amelie as consolidation therapy following chemoradiotherapy in patients with Stage III unresectable NSCLC with EGFR mutations. The interim analysis results of this study were presented as an oral report at the 2024 World Conference on Lung Cancer (WCLC). Data showed that the median progression-free survival (mPFS) assessed by the Independent Review Committee in the Amelie group was 30.4 months, which is 8 times that of the placebo group (mPFS = 3.8 months), with similar benefits observed in the investigator-assessed mPFS, indicating that Amelie’s consolidation therapy effectively reduced the risk of disease progression or death by 85%. Notably, all patients included in the POLESTAR study were Chinese, demonstrating the significant efficacy of the original China-produced EGFR-TKI for Chinese patients, and offering high guidance for clinical practice in China.

In China, NSCLC accounts for approximately 85% of the total number of lung cancer cases, among which nearly one-third are locally advanced (Stage III) NSCLC. For most patients, the optimal opportunity for surgery has been missed at the time of diagnosis, making treatment more challenging and urgently requiring the exploration of more precise and effective treatment methods. In recent years, the rapid development of precision targeted therapies represented by third-generation EGFR-TKIs has provided more treatment options to further enhance the diagnosis and treatment level of inoperable Stage III NSCLC and improve patient prognosis.

The new addition of Amelo to the Class I recommendation for "consolidation treatment after concurrent or sequential chemoradiotherapy in EGFR-sensitive mutation Stage III unresectable NSCLC" confirms its application potential in this field. This holds significant guiding value for the development of precise diagnosis and treatment of NSCLC in China, further enhancing the level of lung cancer diagnosis and treatment in China, and benefiting patients continuously.