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DRUG:

Ameile (aumolertinib)

i
Other names: HS-10296, HS 10296, EQ143, EQ-143, EQ 143, HS10296
Company:
Abdul Latif Jameel Health, Jiangsu Hansoh Pharma
Drug class:
EGFR inhibitor
Related drugs:
3d
Efficacy and safety with aumolertinib plus anlotinib for untreated EGFR-mutant NSCLC with brain metastases. (PubMed, NPJ Precis Oncol)
Aumolertinib plus anlotinib was effective and well-tolerated as first-line therapy in EGFR-mutant NSCLC patients with BMs. Trial Registration: ClinicalTrials.gov(identifier NCT04978753, registered July 20, 2021).
Journal
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EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53)
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TP53 mutation • EGFR mutation • EGFR L858R • EGFR exon 19 deletion • TP53 wild-type • EGFR positive
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Focus V (anlotinib) • Ameile (aumolertinib)
7d
Efficacy of Almonertinib Versus Osimertinib as the First-Line Treatment for Non-Small Cell Lung Cancer With EGFR L858R Mutation and Prognostic Analysis: A Retrospective Comparative Cohort Study. (PubMed, Cancer Med)
Both almonertinib and osimertinib demonstrated good efficacy in patients with brain metastases, and PD-L1 expression was not associated with the prognosis of EGFR L858R mutant NSCLC. Finally, no significant difference between osimertinib and almonertinib for the treatment of patients with EGFR L858R mutations was observed. Both options remain viable for these patients.
Clinical • Retrospective data • Journal • PD(L)-1 Biomarker • IO biomarker
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
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PD-L1 expression • EGFR mutation • EGFR L858R • EGFR exon 19 deletion
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Tagrisso (osimertinib) • Ameile (aumolertinib)
8d
FN-1501 Synergistically Enhances Almonertinib Efficacy in EGFR-TKI-Resistant Lung Adenocarcinoma through Ferroptosis Induction. (PubMed, Anticancer Agents Med Chem)
FN-1501 exhibits significant antitumor activity and, when combined with Alm, effectively reverses EGFR-TKI resistance by inducing ferroptosis, highlighting its potential for clinical application.
Journal
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NCOA4 (Nuclear Receptor Coactivator 4)
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Ameile (aumolertinib) • FN-1501
23d
Case Report: Evolution and targeted therapy of an EGFR-mutant large-cell neuroendocrine carcinoma. (PubMed, Front Oncol)
The patient exhibited a sustained response to first-line osimertinib, with a progression-free survival of 20 months, followed by transformation to small-cell lung cancer (SCLC) confirmed via histopathological reassessment. Second-line treatment with etoposide and cisplatin combined with radiotherapy resulted in an additional 7 months of disease control...Third-line chemotherapy with paclitaxel, carboplatin, and bevacizumab, followed by maintenance therapy with aumolertinib and anlotinib, extended progression-free survival by 21 months. Overall survival reached 48 months. This case highlights the critical importance of repeated molecular profiling and histologic reevaluation in guiding therapeutic decisions for EGFR-mutant LCNEC undergoing phenotypic evolution.
Journal
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EGFR (Epidermal growth factor receptor) • CEACAM5 (CEA Cell Adhesion Molecule 5)
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EGFR mutation • EGFR L858R
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Avastin (bevacizumab) • cisplatin • Tagrisso (osimertinib) • carboplatin • paclitaxel • Focus V (anlotinib) • etoposide IV • Ameile (aumolertinib)
24d
First-Line Third-Generation EGFR Tyrosine Kinase Inhibitor Monotherapy for Advanced EGFR-Mutated Non-Small Cell Lung Cancer: A Systematic Review and Network Meta-Analysis. (PubMed, MedComm (2020))
Osimertinib (HR, 0.90; 95% CrI, 0.83-0.99) and lazertinib (HR, 0.89; 95% CrI, 0.79-1.00) showed overall survival benefits over first-gen TKIs. Furmonertinib, aumolertinib, and osimertinib had lower rates of severe treatment-related adverse events (TRAEs), while befotertinib exhibited the highest risk of grade ≥3 TRAEs (RR, 3.96; 95% CrI, 2.35-7.17). This study is the first head-to-head comparison of third-gen EGFR-TKIs using a Bayesian network meta-analysis, offering critical insights into efficacy and safety. Our results support personalized selection of third-gen EGFR TKIs for patients with advanced EGFR-mutated NSCLC, particularly for subpopulations with CNS metastases or different mutation subtypes.
Retrospective data • Journal
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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Tagrisso (osimertinib) • Ameile (aumolertinib) • Ivesa (firmonertinib) • Lazcluze (lazertinib) • Semena (befotertinib)
27d
Real-world study of first-line therapy with aumolertinib for elderly patients with non-small cell lung cancer harboring EGFR mutation. (PubMed, Medicine (Baltimore))
The median OS was 33.7 months and 30.7 months in the ≥65 and <65 years groups, respectively (P = .851). Adverse events were not statistically different between the 2 groups.The efficacy and safety profile of aumolertinib as a first-line therapy in elderly patients with epidermal growth factor receptor-mutant NSCLC were similar to those observed in the younger subgroup.
Observational data • Retrospective data • Journal • Real-world evidence
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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Ameile (aumolertinib)
1m
Integrated machine learning survival framework for consensus modeling in a large multicenter cohort of NSCLC resistant to aumolertinib. (PubMed, Sci Rep)
Notably, for patients with high ARRPS scores, the addition of CD-437 or TPCA-1 to conventional AUM treatment may help overcome drug resistance. These findings suggest that ARRPS serves as both a prognostic tool and a guide for personalized treatment strategies, potentially optimizing the clinical management of NSCLC patients.
Journal
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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Ameile (aumolertinib)
2ms
HS-10296 (Almonertinib) enhances radiosensitivity in EGFR-mutant NSCLC (including T790M) through inhibition of EGFR downstream signaling and DNA damage repair. (PubMed, Carcinogenesis)
These findings establish HS-10296 as a promising radiosensitizer for EGFR-mutant NSCLC through simultaneous targeting of oncogenic signaling via PI3K/AKT and MAPK/ERK pathways and critical DNA repair mechanisms. The study provides compelling preclinical evidence supporting clinical evaluation of HS-10296 combined with radiotherapy for EGFR-driven NSCLC, including tumors with T790M-mediated resistance.
Journal
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RAD51 (RAD51 Homolog A)
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EGFR mutation • EGFR T790M
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Ameile (aumolertinib)
2ms
Rectal metastasis as the initial presentation of primary lung adenocarcinoma with an EGFR L858R mutation: a case report. (PubMed, World J Surg Oncol)
Although rectal metastasis harbouring EGFR L858R mutations from primary lung adenocarcinoma is extremely rare, clinicians should have a low threshold for pulmonary low-dose spiral CT. In addition, histopathologic analysis by immunohistochemistry combined with molecular diagnostics is critical for a timely and accurate diagnosis and to distinguish rectal metastases from primary rectal malignancies.
Journal
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EGFR (Epidermal growth factor receptor) • NKX2-1 (NK2 Homeobox 1) • CDX2 (Caudal Type Homeobox 2) • NAPSA (Napsin A Aspartic Peptidase)
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EGFR mutation • EGFR L858R
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Ameile (aumolertinib)
2ms
Clinical study of aumolertinib versus osimertinib in the treatment of EGFR-mutated advanced non-small cell lung cancer. (PubMed, Discov Oncol)
Aumolertinib and osimertinib exhibit comparable efficacy and safety profiles in the treatment of EGFR-mutant NSCLC, providing a reference path for clinicians to optimize drug treatment strategies in NSCLC.
Journal
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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Tagrisso (osimertinib) • Ameile (aumolertinib)
2ms
Nutritional status and drug resistance in EGFR-mutant NSCLC: a retrospective cohort study on almonertinib efficacy. (PubMed, Naunyn Schmiedebergs Arch Pharmacol)
The shortened PFS observed in cachectic patients may reflect accelerated disease progression related to poor nutritional status rather than Almonertinib-specific resistance. Moreover, mild to moderate anxiety was observed in all patients receiving Almonertinib, underscoring the importance of incorporating psychological support in cancer care.
Retrospective data • Journal
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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Ameile (aumolertinib)
3ms
New P3 trial
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Ameile (aumolertinib) • ruzaltatug rezetecan (SHR-A2009)