The American Society of Clinical Oncology (ASCO) Annual Meeting is the world's most authoritative academic exchange event in the field of oncology. The Phase III clinical study data of Ameile (Almonertinib Mesilate Tablets), a Class 1 innovative drug independently developed by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. ("Hansoh Pharma"), for the first-line treatment of EGFR-sensitive mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), will be released at the 2021 ASCO Annual Meeting. As China's first original third-generation EGFR-TKI innovative drug, Ameile has made a major breakthrough in the first-line treatment of lung cancer, which will bring more survival benefits to patients with advanced lung cancer.
▲Ameile (Almonertinib Mesilate Tablets)
Major Breakthrough in First-Line Lung Cancer Treatment
The study shows that, compared with the existing first-line standard treatment drug gefitinib:
1.Patients treated with Ameile as first-line therapy had significantly longer progression-free survival (PFS) (median PFS: 19.3 months vs 9.9 months) and significantly longer duration of remission (DoR) (median DoR: 18.1 months vs 8.3 months).
2.Despite the significantly longer duration of dosing in the Ameile group (median duration of dosing: 463 days vs 254 days), the incidence of drug-related rash, diarrhea, elevated AST/ALT, and drug-related serious adverse events (SAEs) was lower (SAEs: 4.2% for almonertinib vs 11.2% for gefitinib).
The study results have demonstrated the advantages of Ameile in safety and efficacy for the first-line treatment of EGFR-sensitive mutation-positive locally advanced or metastatic NSCLC, and the marketing approval application for this indication has been accepted by the National Medical Products Administration and included in the Publicity List of Varieties Subject to Priority Review. This is the second indication for Ameile, which is expected to benefit more patients after approval.
The study results will be presented in a poster discussion at the 2021 ASCO Annual Meeting on June 4 (poster abstract number: 9013).
About the study
This is a multicenter, randomized, double-blind, controlled Phase III study of Ameile vs gefitinib as first-line therapy for patients with EGFR-sensitive mutation-positive locally advanced or metastatic NSCLC, with a total of 400+ subjects enrolled. All the patients enrolled in this study are Chinese patients. It is the first randomized, controlled study of a third-generation EGFR-TKI drug for the first-line treatment of Chinese lung cancer patients, with a higher level of evidence that better reflects the disease status of Chinese lung cancer patients.
About Ameile (Almonertinib Mesilate Tablets)
Ameile (Almonertinib Mesilate Tablets) is China's first original third-generation EGFR-TKI innovative drug independently developed by Hansoh Pharma, and also the world's first third-generation EGFR-TKI with median progression-free survival (mPFS) exceeding one year (second-line use). Ameile was included in the National Reimbursement Drug List in December 2020, and became reimbursable in March 2021. With huge clinical demand and excellent clinical value, Ameile was successfully selected into the Reference List of Medical Institutions Providing Some Negotiated Drugs Newly Included in National Reimbursement Drug List 2020 (First Batch), which will greatly improve the accessibility of domestic innovative drugs.
