From June 4 to 8, the 2021 Annual Meeting of American Society of Clinical Oncology (ASCO), the world's leading academic organization for oncology, was held online in the form of a virtual conference. The latest results from the Phase III clinical study of Ameile (Almonertinib Mesilate Tablets), a Class 1 new drug independently developed by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. ("Hansoh Pharma" or the "Company"), for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with positive EGFR-sensitive mutations were released in a poster session (poster abstract number: 9013) at the 2021 ASCO Annual Meeting. With a median progression-free survival (mPFS) of 19.3 months, the amazing data demonstrate the Company's innovation capability, bring a major breakthrough in first-line lung cancer treatment, and provide new options and survival benefits to more patients with advanced lung cancer.
01.Better choice, the first involving all "Chinese samples" to benefit Chinese patients
Ameile is China's first original third-generation EGFR-TKI innovative drug. The AENEAS study 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. It is the first randomized, controlled, registered clinical 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, it will fill the gap in the evidence for first-line treatment of mutation-positive NSCLC with China's original third-generation EGFR-TKI drugs.
02.Breakthrough innovation, with a mPFS of 19.3 months
The study shows that, compared with the existing first-line standard therapeutic drug gefitinib, the progression-free survival (PFS) of patients using Ameile as first-line treatment was significantly prolonged (median PFS: 19.3 months vs 9.9 months), and the duration of remission (DoR) was also significantly prolonged (median DoR: 18.1 months vs 8.3 months); 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 above findings demonstrate the safety and efficacy benefits of Ameile for the first-line treatment of EGFR-sensitive mutation-positive locally advanced or metastatic NSCLC. This is the second indication for Ameile. The marketing authorization application for this indication has been accepted by the National Medical Products Administration and included in the priority review category. It is expected to benefit more lung cancer patients after approval.
As a leading innovation-driven pharmaceutical company in China, Hansoh Pharma drives development with innovation, strives to create excellence in pharmaceuticals and enhance innovation in China in a focused, dedicated and professional manner, insists on a patient-centered approach, stays focused on unmet medical needs in clinical practice, and pursues to improve human health and well-being by virtue of an advanced innovative R&D system.
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 a 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 its 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.
About the 2021 ASCO Annual Meeting
The American Society of Clinical Oncology (ASCO) is the world's leading academic organization for oncology. As one of the world's largest clinical oncology meetings with the highest academic level, the 2021 ASCO Annual Meeting brings together many world-class oncologists to discuss the latest research results in clinical oncology and tumor treatment technologies.
