Hansoh Pharma Submits New NDA for Aumetinib in Combination with Chemotherapy for EGFR-Mutated Advanced NSCLC
Hansoh Pharma
Pharmaceutical Research, Production, and Sales
Screenshot source: CDE official websiteAENEAS2 is a randomized, open-label, multicenter, Phase III trial, enrolling a total of 624 patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC patients. Patients receive Ameile ( once daily in each cycle.110 mg) Oral tablets, with chemotherapy once every three weeks (Pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 or carboplatin (AUC5)) Combined therapy for a total of four cycles, followed by maintenance therapy with Almonertinib and Pemetrexed once every three weeks.
According to the blinded independent central review, the data from the AENEAS Phase III study indicate that,Patients treated with Almonertinib (Ameile) in combination with chemotherapy experienced more than a 50% reduction in the risk of disease progression or death., with statistical significance.Ameile in Combination with Chemotherapy Extends Median Progression-Free Survival to Over 2 YearsThe safety results were consistent with the established safety profiles of each drug in previous studies, and no new safety signals were identified.
1) Used forSecond-line TreatmentPatients with locally advanced or metastatic NSCLC who have progressed after prior EGFR-TKI treatment and are T790M mutation-positive;
2）First-line treatmentWith EGFR exon 19 deletion or exon 21 (L858R) Positive for substitution mutations in adult patients with locally advanced or metastatic NSCLC.
Used for EGFR exon 19 deletion or exon 21 (L858R) Positive for substitution mutationAdjuvant Treatment for Adult Patients with NSCLC After Tumor Resection（CXHS2400060），Expected to be approved in Q2 next year。 Used to treat unresectable locally advanced EGFR exon 19 deletion or exon 21 (L858R) NSCLC patients with substitution mutations,The application (CXHS2400077) has been included in the priority review, and is expected to be approved in Q1 next year.。
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