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Association details:
| Biomarker: | EGFR mutation |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Ivesa (firmonertinib) (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Central nervous system efficacy of furmonertinib versus gefitinib in patients with non–small cell lung cancer with epidermal growth factor receptor mutations: Results from FURLONG study.
Published date:
05/26/2022
Excerpt:
CNS PFS rate at 6, 12, 18 months were 91%, 77%, 63% in the furmonertinib group, and 76%, 46%, 34% in the gefitinib group. In the cEFR set, confirmed CNS objective response rate was 91% in patients with furmonertinib and 65% in patients with gefitinib (p = 0.0277), and CNS disease control rate were 100% vs 84% (p = 0.9420), respectively....Furmonertinib showed CNS efficacy as first-line therapy in EGFR-mutated NSCLC patients with CNS lesions. Patients treated with furmonertinib had a reduced risk of CNS progression or death, a higher CNS ORR and a deeper CNS response compared with gefitinib.
DOI:
10.1200/JCO.2022.40.16_suppl.9101
Trial ID:
Source:
Title:
To Assess the Efficacy and Safety of Furmonertinib Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy
Excerpt:
...- Confirmation by the central laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M....
Source:
Title:
Efficacy and Safety of Alflutinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer Patients With T790M
Excerpt:
...Evaluation of the objective response rate of Alflutinib in locally advanced or metastatic non-small cell lung cancer patients harbouring acquired T790M mutation by prior therapy with an EGFR-TKI or primary T790M mutation assessed by RECIST 1.1`Objective response rate of Alflutinib...
More C2 evidence
Source:
Title:
Phase Ib Study of FURMONERTINIB in Patients With NSCLC Having Exon 20 Insertion Mutation
Excerpt:
...- The Participants should provide enough ctDNA in peripheral blood during the screening period, and at the same time, they should provide enough advanced tumor tissue sections as far as possible for central laboratory testing to confirm the mutation type of EGFR 20 exon (please refer to the manual of central laboratory for details);...
Trial ID:
Source:
Title:
Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)
Excerpt:
...- Documented validated results confirming the presence of an Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutation in tumor tissue or blood from local or central testing....
Source:
Title:
A multicenter, single-arm clinical study to evaluate the efficacy and safety of Furmonertinib treatment in patients with resectable multiple primary NSCLC after one-side R0 resection
Excerpt:
...Patient diagnosed with Multiple Primary Lung Cancer (MPLC) (based on M-M/ACCP clinical criteria), identified on preoperative chest CT scan (1mm layer thickness) evaluation; patient with resectable multiple lung cancer in both lungs, with R0 resection of the primary lesion on one side (lesion >=1cm, postoperative pathology stage Ib or higher), and confirmed of EGFR gene sensitive mutations (19Del, and or 21L858R mutations). ...
Trial ID:
Source:
Title:
A multicenter, open label, single arm study: furmonertinib as neoadjuvant therapy for resectable stage IIIA EGFR mutant lung adenocarcinoma
Excerpt:
...5.EGFR mutation positive (must include deletion of exon 19 and/or mutation of exon 21 L858R, which can exist alone or in combination); 6.Presence of at least one accurately measurable lesion, computed tomography (CT) showing a maximum diameter of >10mm at baseline (except for lymph nodes with a shorter axis > 15mm) and suitable for accurate repeat measurements; 7.ECOG performance status score 0-1; 8.Sufficient organ function to meet protocol requirements....
Trial ID:
Source:
Title:
High-dose Furmonertinib in first-line treatment of patients with EGFR classically mutated advanced NSCLC: a multicenter, open-label, single-arm, clinical study
Excerpt:
...A histological or cytological report issued or approved by a tertiary Class A hospital or a qualified testing institution confirms the presence of classical EGFR mutations; 7. ...
Trial ID:
Source:
Title:
A Clinical Study of Furmonertinib Combined with Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-IIIA EGFRm NSCLC
Excerpt:
...EGFR-sensitive mutations (either exon 19 deletion or L858R in exon21); 5. ...
Trial ID:
Source:
Title:
AST2818 in Advanced Non-Small Cell Lung Cancer With EGFR Mutations
Excerpt:
...- Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including at least one of G719X, exon 19 deletion, L858R, L861Q mutation)...
Source:
Title:
Alflutinib Mesylate Versus Gefitinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer （FLAG）
Excerpt:
...The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)....
Source:
Title:
Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Alflutinib in Advanced Non Small Cell Lung Cancer
Excerpt:
...Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR TKI sensitivity (including at least one of G719X, exon 19 deletion, L858R, L861Q mutation) 5....
Source:
Title:
High-dose Furmonertinib for First-line Treatment of EGFR Mutated NSCLC With Central Nervous System (CNS) Metastases
Excerpt:
...Documented validated results from local testing of either tumor tissue or blood confirming the presence of EGFR 19del or exon 21del L858R mutation....
Trial ID:
Source:
Title:
Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer
Excerpt:
...- EGFR mutation positive according to NGS testing by tissue, including deletions in exon 19, L858R, S768I, G719X, L861Q, T790M mutations et al....
Trial ID:
Source:
Title:
Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion
Excerpt:
...- Documented validated results from local or central testing (as designated by the Sponsor) of blood or tumor tissue confirming the presence of an EGFR exon 20 insertion mutation...
Trial ID:
Source:
Title:
Study of FURMONERTINIB in Patients With NSCLC Having Exon 20 Insertion Mutation
Excerpt:
...- The treated patients must have radiological disease progression following the last anti-tumor therapy; and the treatment-naïve patients must have documented positive EGFR exon 20 insertion mutation by laboratory tests prior to enrollment;...
Trial ID:
Source:
Title:
First-line Furmonertinib in Advanced NSCLC Patients With EGFR Uncommon Mutation
Excerpt:
...- Patient with EGFR G719X or S768I or L861Q mutation diagnosed histologically or cytologically, the reports must be issued or recognized by Tier 3A hospitals....
Trial ID:
Source:
Title:
Efficacy and Safety of Furmonertinib in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC (FUTURE)
Excerpt:
...The tumour harbours one of the most common EGFR mutations (19del or L858R); 4....
Trial ID:
Source:
Title:
Adjuvant Targeted-therapy for Patients With Resected High-risk EGFR-mutant Stage IB-IIA Non-small Cell Lung Carcinoma
Excerpt:
...The tumour harbours one of the most common EGFR mutations (19del or L858R) ; 7....
Trial ID:
Source:
Title:
Furmonertinib as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable EGFR Mutated Lung Adenocarcinoma (FRONT)
Excerpt:
...- EGFR mutation positive (19Del or L858R, with or without T790M)...
Trial ID:
Source:
Title:
Alflutinib Versus Alflutinib Plus Chemotherapy for NSCLC
Excerpt:
...- an EGFR mutation, including an exon-19 deletion (Ex19del), L858R, or other (L861Q, G719A, G719C, or G719S), as well as the T790M mutation of EGFR as detected in a tissue or liquid biopsy sample obtained after disease progression during first-line EGFR-TKI (gefitinib, erlotinib, or afatinib) treatment;...
Source:
Title:
The efficacy and safety of Furmonertinib in advanced EGFR mutation-positive NSCLC patients with brain metastases based on real-time dynamic monitoring of peripheral blood and CSF
Excerpt:
......
Trial ID:
Less C2 evidence
Source:
Title:
582P - Furmonertinib treatment in patients with EGFR-mutated non-small cell lung cancer and leptomeningeal metastases: A real-world study
Published date:
11/27/2023
Excerpt:
Furmonertinib 240mg/day has demonstrated clinically significant efficacy as first line and salvage therapy in patients with EGFR-mutant NSCLC and leptomeningeal metastases.
Source:
Title:
491P - Furmonertinib as adjuvant therapy for elderly patients in resected EGFR-mutated non-small cell lung cancer: A double-center, real-world experience
Published date:
11/27/2023
Excerpt:
Patients who underwent radical lung cancer surgery with EGFR mutations from two independent medical centers were enrolled and received furmonertinib 80mg daily….This is the first real-world study to demonstrate that furmonertinib has good efficacy and a tolerable safety profile in elderly patients (≥ 65 years) with completely resected stage I-III NSCLC harboring EGFR mutations.
Source:
Title:
1346P - Efficacy and safety of high dose furmonertinib combined with intrathecal injection in EGFR-mutated advanced NSCLC patients with LM progressed on osimertinib
Published date:
10/16/2023
Excerpt:
This retrospective study aimed to evaluate the efficacy and safety of high dose furmonertinib combined with intrathecal injection methotrexate (MTX) or pemetrexed (PEM) in EGFR-mutated NSCLC patients with LM site-specific resistance to osimertinib….High dose furmonertinib combined with intrathecal injection showed encouraging efficacy in EGFR-mutated advanced NSCLC patients progressed on osimertinib or other third-generation TKI.
Secondary therapy:
pemetrexed; methotrexate
Source:
Title:
Efficacy and safety of re-challenging 160 mg furmonertinib for advanced NSCLC after resistance to third-generation EGFR-TKIs targeted agents: A real-world study
Published date:
08/16/2023
Excerpt:
EGFR-mutated NSCLC patients with intracranial progression pattern cohort (IP cohort) or extracranial progression pattern cohort (EP cohort) were retrospectively analyzed following progression to third-generation EGFR-TKIs receiving furmonertinib 160 mg daily as second-line or later treatment in combination with or without anti-angiogenic agents and chemotherapy....In the IP cohort, the median PFS was 5.5 months (95% CI 4.67–8.72), and the median OS was 9.8 months (95% CI 7.25–11.20) for single-agent furmonertinib or combination therapy. In the EP cohort, the median PFS was 3.2 months (95% CI 2.18–4.70), and the median OS was 6.7 months (95% CI 4.99–8.75).
DOI:
https://doi.org/10.1016/j.lungcan.2023.107346
Source:
Title:
299P - Furmonertinib as adjuvant therapy in EGFR-mutated non-small cell lung cancer following radical lung cancer surgery
Published date:
11/28/2022
Excerpt:
Furmonertinib showed good efficacy as adjuvant therapy in EGFR-muteted NSCLC patients who underwent radical lung cancer surgery, along with an acceptable safety profile without new signals.
