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Association details:
| Biomarker: | EGFR exon 20 insertion |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Ivesa (firmonertinib) (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
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:
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:
More C2 evidence
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....
Less C2 evidence
Source:
Title:
A Phase 1b Study Of Furmonertinib, an Oral, Brain Penetrant, Selective EGFR Inhibitor, in Patients with Advanced NSCLC with EGFR Exon 20 Insertions
Published date:
08/08/2023
Excerpt:
Furmonertinib showed promising efficacy and a predictable and manageable safety profile in patients with NSCLC harboring EGFR Exon20ins mutations.
Trial ID:
Source:
Title:
Clinical efficacy analysis of furmonertinib and structural insights into sensitivity to diverse TKIs for NSCLC with EGFR exon 20 insertion.
Published date:
05/25/2023
Excerpt:
Comparative analysis of the efficacy of different groups showed that median PFS was significantly longer in furmonertinib group than in osimertinib (10.2 vs 3.8 mo, p = 0.008). Median OS was numerically longer in furmonertinib group than in osimertinib...rather than erlotinib (GlideScore: -5.564; MM/GBSA: -52.8044), gefitinib (-7.68; -47.317), and afatinib (-5.075; -44.64), furmonertinib (-11.085; -68.1575) and osimertinib (-10.031; -63.87) revealed favorable binding activity to EGFRex20ins, with furmonertinib being the most significant....Furmonertinib might have positive clinical efficacy to advanced NSCLC pts with EGFRex20ins on account of its favorable binding activity to EGFRex20ins.
DOI:
10.1200/JCO.2023.41.16_suppl.e21084
Source:
Title:
39P - Preliminary clinical investigations and mechanism exploration of furmonertinib in NSCLC with EGFR Exon 20 insertion
Published date:
03/23/2023
Excerpt:
Furmonertinib has positive clinical efficacy to advanced NSCLC pts with EGFRex20ins probably based on its favorable binding activity to EGFRex20ins. Furmonertinib may be the optimal choice for these pts in the future.
Source:
Title:
48P - Efficacy analysis and mechanism exploration of furmonertinib for advanced NSCLC with EGFR exon 20 insertion mutation
Published date:
03/02/2023
Excerpt:
We observed 14 pts with PR and six pts with SD as best response to furmonertinib (ORR: 70.0%, DCR: 100%). All pts showed tumor shrinkage in target lesions (median best percent change, -36.43% [-74.78%, -5.56%]). Median PFS was 10.2 (95 % CI, 7.19-13.21) months(mo). Median DOR was 8.5 (95 % CI, 4.97-12.03) mo. Comparative analysis of the efficacy of different groups showed that median PFS was significantly longer in furmonertinib group than in osimertinib (10.2 vs 3.8 mo, p = 0.008)....Furmonertinib has positive clinical efficacy to advanced NSCLC pts with EGFRex20ins probably based on its favorable binding activity to EGFRex20ins.
Source:
Title:
Short-term efficacy of furmonertinib in treatment of NSCLC patients with EGFR exon20 insertion.
Published date:
05/26/2022
Excerpt:
The study retrospectively collected 15 NSCLC patients with EGFR Ex20ins mutant...By the end of follow-up, 15 patients had completed at least one efficacy evaluation, and all had different degrees of tumor regression. No patient reached CR, 8 patients had PR and 7 patients had SD....The overall findings suggested that furmonertinib is a third generation EGFR-TKI with good efficacy and acceptable safety.
DOI:
10.1200/JCO.2022.40.16_suppl.e21063
Source:
Title:
Preliminary clinical investigations of high-dose furmonertinib in NSCLC with EGFR Exon 20 insertions (20ins).
Published date:
05/26/2022
Excerpt:
Retrospective search identified 14 metastatic NSCLC patients (pts) with EGFR 20ins treated with high-dose furmonertinib (160mg qd) in Fudan University Shanghai Cancer Center. The clinical efficacy and safety were investigated....5 out of 9 pts achieved PR, and 3 patients achieved SD. No CR was observed and 1 patient PD at first assessment….High-dose furmonertinib has shown encouraging anti-tumor activity in NSCLC with EGFR 20ins.
DOI:
10.1200/JCO.2022.40.16_suppl.e21029
Source:
Title:
1210P - Preclinical and preliminary clinical investigations of furmonertinib in NSCLC with EGFR exon 20 insertions (20ins)
Published date:
09/13/2021
Excerpt:
10 EGFR 20ins advanced NSCLC pts were enrolled in cohort 1 and received furmonertinib 240mg qd....The best response was PR in 7 pts and SD in 3 pts. 5/7 objective responses (all PR) were confirmed, with 2 awaiting confirmation. All pts showed tumor shrinkage in target lesions (median best percent change, -43.0% [-72.3%, -3.0%]).
Trial ID:
