October [●] 2024
●AMEILE combined with chemotherapy demonstrated statistically significant and clinically meaningful improvement in progression-free survival in patients with EGFR mutated advanced lung cancer.
Hansoh Pharma Pharmaceutical Group Co., Ltd. (Hansoh Pharma, 03692.HK) today announced the Phase III registrational trial AENEAS2 evaluating AMEILE (aumolertinib mesylate tablets), Hansoh Pharma’s third generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI), in combination with chemotherapy as first line therapy for patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFR mutated non-small cell lung cancer (NSCLC), met its primary endpoint of progression-free survival(PFS).
Based on blinded independent central review, data from AENEAS2 phase III demonstrate a statistically significant risk reduction over 50% in disease progression or death in patients with the combination of AMEILE and chemotherapy in comparison to AMEILE monotherapy. The median progression-free survival of AMEILE and chemotherapy combination has been extended to over 2 years. Safety results were consistent with the established profiles of each medicine that observed in previously reported studies. No new safety signals were identified.
“AENEAS2 represents a groundbreaking study, demonstrating significant advancements in the treatment of first-line NSCLC patients with EGFR mutations, and underscores the potential of AMEILE in enhancing efficacy within this population," said Prof. Shun Lu, Director of the Lung Cancer Center at Shanghai Chest Hospital and principal investigator for the trial. "The statistically significant and clinically meaningful results further emphasize the potential of AMEILE in treating EGFR-mutated NSCLC patients. We are eager to share these exciting findings at upcoming medical conferences.”
“These promising results from the AENAES2 study could bring a new combination therapy option to patients with advanced EGFR-mutated lung cancer,” said Ms. Eliza Sun, Executive Director of the Board at Hansoh Pharma. “The significant improvement in progression-free survival underscores the potential of AMEILE in combination with chemotherapy. We remain committed to addressing the unmet needs of patients with EGFR-mutated non-small cell lung cancer.”
Following the successful demonstration of AMEILE's efficacy in AENAES Phase III study in first-line settings as mono therapy, data from AENAES2 has proven the efficacy of AMEILE in combination with chemotherapy as a potential first-line treatment. Detailed results of the study will be presented at upcoming medical conference and will be submitted to regulatory authority.
About 阿美乐® (AMEILE)
AMEILE is currently approved for the first-line treatment for adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitute mutation positive, and approved for the treatment of patients with locally advanced or metastatic NSCLC with T790M mutation, who have progressed on or after EGFR-TKI therapy. Two additional indications are under sNDA review, including Adjuvant therapy for early-stage settings and Treatment for Stage III locally advanced unresectable NSCLC.
About the AENEAS2 Trial
AENEAS2 is a randomized, open-label, multi-center, Phase III trial in the first line treatment of 624 patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC. Patients were treated with AMEILE ® (aumolertinib 110 mg) once daily oral tablets in combination with chemotherapy (pemetrexed 5 00mg/m2plus cisplatin 75mg/m2 or carboplatin (AUC5)) every three weeks for four cycles, followed by AMEILE with pemetrexed maintenance every three weeks.
About Lung cancer
Lung cancer remains the leading cause of both cancer incidence and mortality in China. According to statistics from 2022, approximately 1.06 million new lung cancer cases were reported in China, accounting for 22.0% of all malignancies, with 740,000 cancer-related deaths, representing 28.5% of all cancer fatalities. 1 Among these cases, non-small cell lung cancer (NSCLC) is the most prevalent type, constituting 85% of all diagnoses.2 Patients with EGFR mutations are particularly responsive to EGFR-TKIs, a class of targeted therapies that block specific signaling pathways that promote tumor growth.3
Reference:
1.Liu, Y., Chen, H., & Zhou, Q. (2020). Targeted therapies for EGFR-mutant lung cancer: Advances and challenges. Journal of Thoracic Oncology, 15(5), 743-755. https://doi.org/10.1016/j.jtho.2020.01.008
2.Wang, X., & Li, Y. (2021). Non-small cell lung cancer: Advances in diagnosis and treatment. Chinese Medical Journal, 134(10), 1234-1242. https://doi.org/10.1097/CM9.0000000000001511
3.Zhang, L., Sun, Y., & Li, Q. (2022). Lung cancer statistics in China: Incidence and mortality. Cancer Research, 82(12), 2303-2310. https://doi.org/10.1158/0008-5472.CAN-22-0453
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