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2023 ELCC | Multiple studies of Hansoh Pharma's aumolertinib to be presented once more at authoritative international academic conference
Release Date:2023/03/23
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   The European Lung Cancer Congress (ELCC) 2023 will be held in Copenhagen, Denmark from March 29-April 1, 2023. ELCC 2023 will report a total of 11 EGFR-TKI related studies with Chinese investigators as first or corresponding authors, including 5 results related to Hansoh's innovative drug aumolertinib (Ameile), accounting  for 45% of the total number of abstracts, ranking first among all EGFR-TKI.

   ELCC is one of the major academic conferences in the field of lung cancer, organized by the European Society for Medical Oncology (ESMO) and the International Association for the Study of Lung Cancer (IASLC), dedicated to advancing science, disseminating education and improving the practice of lung cancer specialists worldwide. Five abstracts of aumolertinib were selected in the ELCC 2023, including three study data and two study designs, bringing the latest advances in EGFR-TKI plus radiotherapy, adjuvant therapy and high-dose treatment of brain metastases for non-small cell lung cancer (NSCLC).

18P - Stereotactic radiotherapy(SRT) in combination with Aumolertinib to treat intracranial oligometastatic Non-Small Cell Lung Cancer (NSCLC): An update of the phase II, prospective study

Jiayan Chen, Fudan University Shanghai Cancer Center

This study (NCT04519983) aimed to investigate the efficacy and safety of aumolertinib followed by SRT in patients with intracranial oligometastatic NSCLC. Intracranial oligometastatic patients with EGFR sensitive mutations (EGFR-TKIs naive) were enrolled and received aumolertinib 110mg daily until intracranial disease progression. Then SRT (3240Gy total, 8Gy/f) was given to intracranial oligo-progression disease. The primary endpoint was intracranial objective response rate (iORR). Secondary endpoints included intracranial progression-free survival (iPFS), intracranial duration of response (iDOR), cerebral radiation necrosis rate (CRNR) and overall survival (OS). At data cut-off, 35 patients were enrolled and 32 patients were assessed, and followed for 3 months to 16 months. The best response of all patients in intracranial and extracranial lesions was partial response (PR), with an iORR of 100%. No grade ≥3 adverse events occurred.

97P - Aumolertinib as adjuvant therapy in postoperative EGFR-mutated stage I-III non-small cell lung cancer with high-risk pathological factors

Yuwei Shen, Ningbo Medical Center Lihuili Hospital

Haibo Shen, Ningbo No.2 Hospital

This study aimed to observe the efficacy and safety of adjuvant aumolertinib in NSCLC patients with high-risk pathological factors. A total of 115 stage I–III lung adenocarcinoma with micropapillary or solid component patients were enrolled. 45 EGFR mutation-positive patients (exon 19 deletion or L858R) were assigned to group A and received aumolertinib (110 mg daily). 25 EGFR mutation-positive patients were assigned to group B and 45 EGFR mutation-negative or unknown patients were assigned to group C, both received observation for disease recurrence and no adjuvant therapy was given. At data cut-off, all patients in aumolertinib group have no symptoms of tumor recurrence and continued aumolertinib, the 1-year disease-free survival (DFS) was 100%. In group B, 64% patients were alive and disease-free, 3 of 25 patients had tumor recurrence within 1 year (1-year DFS: 88%). In group C, 89% patients were alive and disease-free, 1-year DFS was 93%. There were no grade ≥3 adverse events occurred.

98P - Adjuvant aumolertinib in resected EGFR-Mutated Non-Small-Cell Lung Cancer: a multiple-center real-world experience

Jian Hu, The First Affiliated Hospital, Zhejiang University School of Medicine

This study aimed to evaluate the long-term efficacy and safety of adjuvant aumolertinib in postoperative patients. A total of 215 patients who underwent radical lung cancer surgery with EGFR-sensitizing mutations from four different medical centers were enrolled and received aumolertinib 110 mg daily, the medication time (6 months-36 months) depended on the pathological stage and physical conditions. The DFS, safety and tolerability were evaluated. All patients were followed for at least 6 months, 40 patients have been followed up for over 2 years, and 110 patients have been followed for over 1 year. At data cutoff, only one patient had bone metastasis, and no patient presented with CNS metastasis. 2-year DFS was 99%. 69 patients (69/215, 32.1%) experienced drug-related adverse reactions, and there were no grade ≥3 adverse events occurred.

80TiP - High-dose Aumolertinib Versus Osimertinib in EGFR T790M+ NSCLC Patients With Brain Metastases (ATTACK)

Shun Lu, Shanghai Chest Hospital, Shanghai JiaoTong University

ATTACK (NCT04870190) is a multicenter, open-label, randomized, controlled trial  to evaluate the efficacy and safety of aumolertinib compared with osimertinib in EGFR T790M+ NSCLC patients with brain metastases. Approximately 232 patients will be randomized (1:1) to receive either 165 mg aumolertinib or 80 mg osimertinib, administered once daily orally, stratified by the type of EGFR mutation (Ex19del or L858R). Treatment continues in 21-day cycles until disease progression, withdrawal of consent, the development of unacceptable side effects, or the fulfillment of other discontinuation criteria. The primary endpoint is iPFS. Secondary endpoints include PFS, objective response rate (ORR), disease control rate (DCR), iORR, intracranial DCR (iDCR), overall survival (OS), and safety. The first patient had been enrolled in November 2022.

104TiP - MRD Evaluation of Aumolertinib in EGFR Mutation-positive stage IB and stage IA2-3 NSCLC After Complete Surgical Resection: A Multicenter, Open-lable, Single-arm Study (ASSIST)

Chao Cheng, The First Affiliated Hospital of Sun Yat-sen University

The ASSIST (ChiCTR2200063184) study is designed to assess the efficacy and safety of aumolertinib as adjuvant therapy in pts with EGFR-mutant stage IB and stage IA2-3 NSCLC according to minimal residual disease (MRD) detection. Approximately 130 patients will receive aumolertinib 110 mg orally once daily until disease progression or complete the overall treatment for 3 years. Stratified by the results of two postoperative MRD detections. Patients will receive aumolertinib as adjuvant therapy regardless of whether MRD was positive or negative. Plasma samples will be collected at week 12 and 24 after surgery and every 24 weeks at each follow-up time to evaluate MRD status. The primary endpoint is DFS rate at 3 years. Secondary endpoints include DFS rate at 4 and 5 years, OS and safety. The first patient in (FPI) was in July 2022, and the estimated study completion date is Q3 2024.