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The American Society of Clinical Oncology (ASCO) annual meeting is the most authoritative academic exchange event in the field of oncology in the world.
Jiangsu Hausen Pharmaceutical Group Co.
, Ltd.
independently developed a category 1 innovative drug Amelo® (Ametinib mesylate) for the first-line treatment of EGFR The data of the Phase III clinical study of sensitive mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) will be announced at the 2021 ASCO annual meeting
.
As the first Chinese original third-generation EGFR-TKI innovative drug, Amelox® has made a major breakthrough in the field of first-line treatment of lung cancer, which will bring more survival benefits to patients with advanced lung cancer
Major breakthrough in first-line lung cancer treatment
Studies have shown that compared with the existing first-line standard treatment drug gefitinib:
- Patients using Amelox® as the first-line treatment have significantly prolonged progression-free survival (PFS) (median PFS 19.
3 months vs 9.
9 months), and duration of remission (DoR) also significantly prolonged (median DoR 18.
1 months vs 8.
3 Months)
. - Although the medication time of the Amelox® group was significantly longer (median medication time was 463 days vs.
254 days), the incidence of drug-related rashes, diarrhea, elevated AST/ALT, and drug-related serious adverse reactions (SAEs) was lower (SAEs) : Ametinib 4.
2% vs Gefitinib 11.
2%)
.
The results of the study have shown the safety and effectiveness of Amelox for the first-line treatment of EGFR-sensitive mutation-positive locally advanced or metastatic NSCLC.
The application for marketing authorization for this indication has been accepted by the National Medical Products Administration and has been accepted by the National Medical Products Administration.
Included in the public list of priority review varieties
.
This is the second indication for Amelor®, and it is expected that more patients will be benefited after approval
The results of this study will be presented in the form of a poster discussion at the 2021 ASCO annual meeting on June 4 (post summary number 9013)