Ameile (aumolertinib)

Furthermore, subsequent-line treatment multivariate Cox regression analysis showed a statistically significant impact of elevated creatine kinase on median PFS (p = 0.026) and a significant effect on the number of metastatic organs (p = 0.017), co-mutation (p = 0.035), and elevated creatine kinase (p = 0.014) on median OS. Aumolertinib has shown clinical significance and can safely be used in the real-world setting for patients with EGFR mutation-positive NSCLC.

P2, N=63, Active, not recruiting, Zhejiang Cancer Hospital | Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2024 --> Jun 2024

P2, N=56, Active, not recruiting, Shanghai Pulmonary Hospital, Shanghai, China | Recruiting --> Active, not recruiting

P2, N=22, Recruiting, The First Affiliated Hospital of Guangzhou Medical University | Not yet recruiting --> Recruiting

Pharmacological inhibition of MMP-9 could overcome resistance to almonertinib, as evidenced in both in vitro and in vivo models. Our findings suggest that LCN2 was a crucial regulator for conferring almonertinib-resistance in NSCLC and demonstrate the potential utility of targeting the LCN2-MMP-9 axis for clinical treatment of almonertinib-resistant lung adenocarcinoma.

P2, N=85, Not yet recruiting, Sun Yat-sen University

P2, N=108, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

We reported a patient with lung adenocarcinoma who developed EGFR-T790M mutation after first-line treatment with icotinib and sarcoma transformation after second-line treatment with almonertinib. Sarcoma transformation can be one of the forms of drug resistance in patients with lung adenocarcinoma with EGFR-TKIs. The prognosis of patients with adenocarcinoma after transformation into sarcoma is poor.

P2, N=100, Recruiting, The Second Affiliated Hospital of Shandong First Medical University; The Second Affiliated Hospital of Shandong First Medical University

P3, N=192, Recruiting, Guangdong Association of Clinical Trials | Not yet recruiting --> Recruiting | Phase classification: P2 --> P3 | Trial completion date: Aug 2024 --> Dec 2026 | Trial primary completion date: Oct 2022 --> Dec 2024

No abstract available

P2, N=13, Recruiting, Fujian Cancer Hospital | Not yet recruiting --> Recruiting | N=134 --> 13 | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: May 2023 --> Dec 2023

Our findings indicate that aumonertinib is as effective as osimertinib in treating EGFR19del, while also exhibiting a lower occurrence of adverse skin reactions. This may result in an improved quality of life for patients.

Aumolertinib inhibits proliferation, survival, invasion and migration and induces apoptosis in SH-SY5Y cells by downregulating MMP2 and MMP9 expression.

P3, N=314, Not yet recruiting, Jiangsu Hansoh Pharmaceutical Co., Ltd.

As of August 23, 2023, the first generation EGFR-TKIs, gefitinib, icotinib, and erlotinib; the second generation EGFR-TKIs, afatinib and dacomitinib; and the third generation EGFR-TKIs, osimertinib, almonertinib, furmonertinib and befotertinib were all approved for marketing by China National Medical Products Administration (NMPA). In addition, multiple domestic third-generation EGFR-TKIs are undergoing clinical trials, such as rezivertinib (BPI-7711), limertinib (ASK120067), and oritinib (SH-1028). Meanwhile, mobocertinib and sunvozertinib, which targets EGFR 20ins mutations, were also approved by NMPA. With the increasing variety of EGFR-TKIs approved for marketing subsequently, it brings confusion to clinicians when choosing specific medications, and there is an urgent need to develop relevant treatment guidelines. Hence, the Medical Oncology Branch of China International Exchange and Promotive Association for Medical and Health Care and the Chinese Association for Clinical Oncologists convened experts to integrate the research results of various EGFR-TKIs, and proposed the "China clinical practice guideline for epidermal growth factor receptor tyrosine kinase inhibitors in stage Ⅳ non-small cell lung cancer (version 2023)", to provide reference for better clinical practice.

P=N/A, N=30, Recruiting, Kunming Medical University

P1/2, N=270, Not yet recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd.

The results of qRT-PCR showed that almonertinib reduced the expression of Cyp3a1 in liver and intestine, and Abcb1a, Abcg2 in intestine and kidney. The pharmacokinetic results suggest that it is important to take special care of the interactions of these drugs in clinical applications.

The primary endpoints are Objective Response Rate (ORR) and the duration of PS improved from 3 at baseline to 1. Secondary endpoints are progression-free survival (PFS), overall survival (OS), quality of life (QoL), disease control rate (DCR) and safety.

Conclusions This study demonstrated the significant efficacy of aumolertinib as adjuvant therapy for completely resected stage I-III EGFR-mutated NSCLC, and reported the consistent efficacy of aumolertinib in pts with co-mutation for the first time. Our study is still ongoing to expand the cohort of pts with co-mutation and extend the follow-up period to determine longer-term outcomes.

No abstract available

No abstract available

P3b, N=8, Terminated, EQRx International, Inc. | Trial completion date: Feb 2028 --> Aug 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Feb 2027 --> Aug 2023; The study is being closed based on corporate changes at EQRx and is not related to any efficacy or safety issues with aumolertinib.

This report showed pronounced intracranial objective response benefit in patients with intracranial oligometastatic disease followed by SRT after intracranial oligo-progression and no new safety signals. Aumolertinib has promising efficacy and good tolerability in intracranial oligometastatic EGFR mutated NSCLC. [Keywords] Non-small cell lung cancer; epidermal growth factor receptor tyrosine kinase inhibitor; Aumolertinib; Stereotactic radiotherapy.

In terms of safety, most of the adverse events (AEs) were mild, with no grade 4-5 in the two groups, and the overall tolerance of patients was good. For advanced NSCLC patients with EGFR mutations, second-line treatment with almonertinib plus chemotherapy significantly improved PFS compared with almonertinib alone without a significant increase in adverse events, providing efficacy and safety.

P3, N=98, Recruiting, Qianfoshan Hospital | .

This is the first prospective real-word study to explore the efficacy and safety of third-genaration EGFR-TKI aumolertinib as the first-line treatment for patients with uncommon EGFR mutation of C1 coal-accumulating areas, which can provide an opportunity to improve rates of cure. Trial recruitment is ongoing.

P2/3, N=40, Not yet recruiting, Laibin People's Hospital

P3b, N=8, Active, not recruiting, EQRx International, Inc. | Recruiting --> Active, not recruiting | N=500 --> 8

P2, N=63, Recruiting, Zhejiang Cancer Hospital | Not yet recruiting --> Recruiting | Trial completion date: Jul 2023 --> Jul 2024 | Trial primary completion date: Mar 2023 --> Mar 2024

The most common treatment-emergent adverse events (TEAEs) in AUM + APA and AUM arms were diarrhea (31% vs 12%), rash (29% vs 10%), proteinuria (27% vs 6%), platelet count decreased (25% vs 4%), hypertension (25% vs 6%), creatine kinase increase (23% vs 16%), respectively. Conclusions The combination of AUM + APA may provide a more effective and well tolerable treatment option for the first line treatment in EGFR mutated NSCLC patients.

This study aims to assess the efficacy and safety of high-dose aumolertinib combined Ommaya reservoir intrathecal chemotherapy with pemetrexed for LM from EGFR-mutated NSCLC and explore the efficacy prognostic value of dynamic changes in cell-free DNA (cfDNA) profiles. This study will enroll approximately 40 patients with LM from EGFR-mutated NSCLC (exon 19 deletion or L858R). The primary endpoint is progression-free survival (PFS) according to RECIST 1.1 criteria. The secondary endpoints include intracranial progress free survival (iPFS), objective response rate (ORR), disease control rate (DCR), duration of remission (DoR), overall survival (OS) and therapeutic toxicities.

Recruitment of this study is ongoing, and the first patient in (FPI) was in January 2022. Up to April 2023, more than half of the patients have been enrolled.

In patients with advanced NSCLC harboring uncommon EGFR mutations, high-dose aumolertinib demonstrated a tolerable safety profile and encouraging antitumor activity in NSCLC pts harboring uncommon EGFR mutations. High-dose aumolertinib is also currently being evaluated in a phase 3 clinical trial for patients with uncommon EGFR mutations (NCT04951648).

ALWAYS study demonstrated that aumolertinib plus anlotinib as 1st-Line Treatment for advanced EGFR mutant NSCLC had a promising anti-tumor activity with a manageable safety profile. In addition, this combination treatment also showed a meaningful clinical control in NSCLC patients with brain metastases.

We reported a patient with EGFR-mutant NSCLC with brain metastases who benefited from aumolertinib more than 33 months and have surprising intracranial efficacy as CR. In this case, aumolertinib proved to be a highly effective and well-tolerated treatment option for NSCLC with brain metastases.

The main treatment regimens are aumolertinib monotherapy (18.2%), aumolertinib combined with WBRT (36.4%) or bevacizumab (18.2%). This retrospective study first demonstrated aumolertinib monotherapy or combined with local therapy had prolong the survival time and also improve the BM-related neurological symptoms and quality of life, no matter the first-line or therapy.