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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Title:

367P - High-dose aumolertinib in EGFR-mutant NSCLC patients with brain metastases: Primary data from ACHIEVE

Published date:
11/28/2022
Excerpt:
Treatment-naïve EGFR-mutant NSCLC patients with asymptomatic brain metastases received aumolertinib 165mg orally once daily….The overall ORR was 90.9% (20/22; 95% CI: 70.8-98.9). The CNS ORR was 86.3 (19/22; 95% CI: 65.1-97.1). The overall and CNS DCR were both 100%.
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Aumolertinib activity in patients with CNS metastases and EGFR-mutated NSCLC treated in the randomized double-blind phase III trial (AENEAS).

Published date:
05/26/2022
Excerpt:
Au also achieved longer CNS median PFS over G in cFAS (29.0 vs 8.3 months; HR = 0.323; 95% CI, 0.181-0.576; P< 0.0001)….Au demonstrated superior clinical efficacy against CNS metastases over G as first-line therapy in EGFR-mutated advanced NSCLC, and the safety profile was consistent with that reported previously.
DOI:
10.1200/JCO.2022.40.16_suppl.9096
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Almonertinib With Chemotherapy in mEGFR NSCLC

Excerpt:
...The tumor harbors 1 of the 2 common epidermal growth factor receptor (EGFR) mutations known to be associated with Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) sensitivity (Ex19del or L858R), either alone or in combination with other epidermal growth factor receptor (EGFR) mutations, which may include T790M....
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Real-world protocol for first-line ematinib therapy in patients with locally advanced or metastatic NSCLC who are EGFR mutation-positive (21 L858R)

Excerpt:
...A tumor tissue sample or blood sample was confirmed as an EGFR-sensitive mutation (21 L858R) by an investigator-approved local laboratory test. ...
More C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

480P - Aumolertinib as adjuvant therapy for resectable stage I-III EGFR-mutant NSCLC: Also effective in EGFR co-mutation

Published date:
11/27/2023
Excerpt:
The 1-year DFS rate is 100%....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.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Almonertinib plus chemotherapy versus almonertinib alone in second-line treatment of advanced non-small cell lung cancer with mutated epidermal growth factor receptor: a retrospective study

Published date:
09/27/2023
Excerpt:
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.
Secondary therapy:
Chemotherapy
DOI:
10.3389/fonc.2023.1248690
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Conversion to Aumolertinib in NSCLC Patients with EGFR Mutations Who Are Safety Intolerant after Osimertinib Treatment: A Retrospective Study

Published date:
08/08/2023
Excerpt:
We retrospectively collected data from NSCLC patients with EGFR-mutation who were intolerant after osimertinib treatment and received aumolertinib 110mg daily...15 patients subsequently received aumolertinib treatment. The 3-month conversion success rate was 100%, and overall ORR was 80% (2 CR, 10 PR, 95% CI: 51.9-95.7), DCR was 100%. ORR in subgroups with safety intolerance (rash and diarrhea) after treatment with osimertinib were respectively 87.5% (2 CR, 5 PR, 95% CI: 47.3-99.7) and 100% (2 CR, 4 PR).... This study confirmed safety and efficacy of aumolertinib in EGFR-mutation advanced NSCLC patients with safety intolerance after treatment with osimertinib...
Evidence Level:
Sensitive: C3 – Early Trials
Title:

The Safety and Efficacy of Aumolertinib in Advanced EGFR-mutant NSCLC Patients Who Were Intolerant to Osimertinib Treatment

Published date:
08/08/2023
Excerpt:
Aumolertinib is a safety and efficacy choice in locally advanced or metastatic EGFR-mutant NSCLC pts who were intolerant to osimertinib treatment.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Safety and Efficacy of Aumolertinib in Patients with advanced NSCLC Harboring Uncommon EGFR Mutations: Cohort 2 Updated

Published date:
08/08/2023
Excerpt:
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.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

A Study of Aumolertinib Monotherapy or Combination Treated EGFR-mutated NSCLC Patients with Symptomatic Brain Metastases

Published date:
08/08/2023
Excerpt:
The study retrospectively analyzed 33 patients with advanced EGFR-mutated positive NSCLC with symptomatic brain metastases….The confirmed partial response (PR) were 9 (40.9%) patients and stable disease (SD) were 13 (59.1%) patients, all the patients had progressed. The ORR was 40.9% (9/22) and the DCR was 100 % (22/22). The median PFS and OS were 12.1months and 32.0 months, respectively. The main treatment regimens are aumolertinib monotherapy (40.9%), aumolertinib combined with WBRT (36.4%)....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.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

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

Published date:
03/23/2023
Excerpt:
Intracranial oligometastatic patients with EGFR sensitive mutations (EGFR-TKIs naive) were enrolled and received aumolertinib 110 mg daily until intracranial disease progression….After administration of aumolertinib, the best response of all patients in intracranial and extracranial lesions was partial response (PR), with an iORR of 100%.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

371P - Real-world data of first-line treatment with aumolertinib for elderly EGFR+ NSCLC patients

Published date:
11/28/2022
Excerpt:
This study enrolled pts with stage IIA-IVB EGFR+ NSCLC who received aumolertinib alone as first-line therapy...Overall, ORR and DCR were 74.2% and 97.0%, respectively...ORR was 71.4% and 77.4% for pts ≥65 and <65 yr, respectively, and DCR was 97.1% and 96.8%, respectively.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

375P - Stereotactic radiotherapy (SRT) in combination with aumolertinib to treat intracranial oligometastatic non-small cell lung cancer (NSCLC): A phase II, prospective study

Published date:
11/28/2022
Excerpt:
Aumolertinib showed preliminary efficacy and good tolerability in intracranial oligometastatic EGFR mutated NSCLC.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

EP08.02-004 - Aumolertinib in Treatment-Naïve EGFR-mutant NSCLC Patients With Brain Metastases: Primary Efficacy and Safety Data from the ARTISTRY

Published date:
07/12/2022
Excerpt:
Aumolertinib showed preliminary antitumor activity with a manageable safety profile as first-line therapy in EGFR-mutant NSCLC patients with brain metastases.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

EP08.02-006 Data from Real World to Evaluate the Efficacy of Almonertinib in EGFR-mutant NSCLC Patients

Published date:
07/12/2022
Excerpt:
100 patients’ medical records were reviewed for EGFR mutated ANSCLC treated with almonertinib, Data from 2020/4/1 to 2021/3/1 in Henan Cancer Hospital were also collected and retrospectively analyzed…. The ORR of the patients who received almonertinib as first-line treatment (n=45) was 71%, mPFS was 16.7 months, and mOS was still not reached....Almonertinib has been shown good efficacy and safety in EGFR-mutant ANSCLC.... Elevated creatine kinase is an important predictor of longer mPFS.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

86P-Aumolertinib as adjuvant therapy in postoperative EGFR-mutated non-small cell lung cancer

Published date:
03/23/2022
Excerpt:
At the data cutoff, all patients have no symptoms of tumor recurrence, 25 (37.9%) patients have been followed up for over 1 year. At 12 months, 100% patients were alive and disease-free...This is the first study to demonstrate that aumolertinib has preliminary efficacy and a tolerable safety profile in patients with completely resected stage I-III NSCLC harboring EGFR mutations.
DOI:
https://doi.org/10.1016/j.annonc.2022.02.09687
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Intracranial complete remissions in an aumolertinib-treated EGFR mutation-positive non-small cell lung cancer (NSCLC) patient with symptomatic brain metastases and Eastern Cooperative Oncology Group performance status (ECOG PS) up to 4: a case report

Published date:
02/28/2023
Excerpt:
Further tissue and imaging analysis revealed EGFR-mutant stage IV (cT2N3M1) NSCLC...After 2 weeks of aumolertinib administration, the patient showed significant improvement...
DOI:
10.21037/tcr-22-1614
Evidence Level:
Sensitive: D – Preclinical
Title:

Sequence-dependent synergistic effect of aumolertinib-pemetrexed combined therapy on EGFR-mutant non-small-cell lung carcinoma with pre-clinical and clinical evidence

Published date:
05/03/2022
Excerpt:
Their inhibition effects on cell proliferation and metastasis were firstly compared upon three human NSCLC cell lines in vitro...Aumolertinib-pemetrexed combined therapy is promising for EGFR mutant NSCLC but only in right administration sequence.
Secondary therapy:
pemetrexed
DOI:
https://doi.org/10.1186/s13046-022-02369-3