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    DRUG:

    Ivesa (firmonertinib)

    i
    Other names: AST2818
    Company:
    Allist, ArriVent
    Drug class:
    EGFR inhibitor
    Related drugs:
    1d
    Favorable response to third-generation TKI furmonertinib in a patient with early-stage non-small cell lung cancer​ harboring rare compound EGFR mutations: Exon 18 G719C and Exon 20 S768I - A Case Report. (PubMed, Front Oncol)
    Here, we describe a case of early-stage non-small cell lung cancer (NSCLC) harboring a G719C+S768I compound mutation that achieved complete remission following treatment with furmonertinib. These findings suggest that furmonertinib may represent a promising therapeutic option to improve cure rates in this subset of patients.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR S768I
    |
    Ivesa (firmonertinib)
    3d
    Pulsatile High-dose Furmonertinib in EGFR-mutant NSCLC with Leptomeningeal Metastasis (ChiCTR2600116031)
    P=N/A, N=42, Not yet recruiting, Guangdong Provincial Hospital of Traditional Chinese Medicine; Guangdong Provincial Hospital of Traditional Chinese Medicine
    New trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Ivesa (firmonertinib)
    3d
    Exploration of the Efficacy and Safety of metronomic chemotherapy with vinorelbine capsules combined with third-generation EGFR-TKI as First-Line Treatment in Elderly Patients with Advanced Non-Small Cell Lung Cancer with EGFR Mutations (ChiCTR2500115674)
    P=N/A, N=66, Not yet recruiting, Beijing hospital; Beijing hospital
    New trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Tagrisso (osimertinib) • Ameile (aumolertinib) • vinorelbine tartrate • Ivesa (firmonertinib) • simmitinib (SYHA1817)
    3d
    A Multicenter Exploratory Clinical trail （BEACON）of Furmonertinib Combined with Chemotherapy or Furmonertinib Monotherapy as First-Line Treatment for Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) with Brain Metastases (ChiCTR2500114039)
    P=N/A, N=60, Completed, Dongguan People's Hospital; Dongguan People's Hospital
    New trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Ivesa (firmonertinib)
    3d
    Neoadjuvant 160mg Furmonertinib and Cisplatin/Pemetrexed in EGFR Mutated Stage II-IIIB Resectable NSCLC: A prospective multicenter single-arm clinical study (ChiCTR2600116854)
    P2, N=27, Not yet recruiting, Army Medical Center of PLA; Army Medical Center of PLA
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    cisplatin • pemetrexed • Ivesa (firmonertinib)
    3d
    A Single-Arm, Multicenter, Phase II Clinical Trial of Firmonertinib in Combination With Definitive Radiotherapy for Patients With Stage III Unresectable Pulmonary Adenocarcinoma Harboring Positive EGFR Uncommon Driver Mutations (ChiCTR2500114582)
    P2, N=15, Not yet recruiting, Hunan Cancer Hospital; Hunan Cancer Hospital
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
    |
    Ivesa (firmonertinib)
    7d
    Zipalertinib-A Novel Treatment Opportunity for Non-Small Cell Lung Cancers with Exon 20 Insertions and Uncommon EGFR Mutations. (PubMed, Cancers (Basel))
    The role and the integration of therapies targeting exon20ins or uncommon mutations into the first- and second-line treatment armamentarium for NSCLC patients is not yet fully established, and the therapeutic impact of monotherapies (e.g., sunvozertinib, firmonertinib) versus combinations with standard platinum-based chemotherapy (e.g., zipalertinib, amivantamab) currently still lacks robust evidence to further change the therapeutic landscape for these patients. Therefore, results from the ongoing trials are eagerly awaited and are expected to shed some light on these open questions.
    Review • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR T790M • EGFR L861Q • EGFR G719X • EGFR S768I
    |
    Ivesa (firmonertinib) • Zegfrovy (sunvozertinib) • zipalertinib (CLN-081)
    8d
    Furmonertinib 160mg vs 80mg + Chemotherapy in EGFR-Mutated NSCLC With Brain Metastases: Efficacy and Safety Study (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    carboplatin • pemetrexed • Ivesa (firmonertinib)
    8d
    Prolonged survival in EGFR exon 20 insertion mutant lung adenocarcinoma: case report of sequential osimertinib and furmonertinib with research trend analysis. (PubMed, Front Med (Lausanne))
    This analysis demonstrated a growing global research focus on third-generation EGFR-TKIs and variant-specific treatment strategies for EGFR ex20ins-mutant NSCLC, supporting the rationale underpinning the therapeutic approach adopted in this report. Sequential high-dose third-generation EGFR-TKIs may offer clinically meaningful benefit in selected EGFR ex20ins cases; however, this strategy remains non-standard and should be regarded as hypothesis-generating, warranting further prospective evaluation.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • ETV6 (ETS Variant Transcription Factor 6) • SMAD4 (SMAD family member 4) • SETD2 (SET Domain Containing 2, Histone Lysine Methyltransferase)
    |
    PD-L1 expression • TP53 mutation • EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • Ivesa (firmonertinib) • simmitinib (SYHA1817)
    11d
    Furmonertinib in lung adenocarcinoma with EGFR exon 20 insertion mutation: A case report of positive outcome. (PubMed, Medicine (Baltimore))
    Furmonertinib, as a third-generation EGFR-TKI, demonstrated substantial efficacy in patients with advanced EGFR20ins-mutant NSCLC, significantly extending PFS and improving quality of life. This drug offers a promising new treatment option for patients with resistance to conventional therapies. Further studies will help validate the application of furmonertinib in a broader patient population.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Ivesa (firmonertinib)
    15d
    Double-dose firmonertinib as first-line treatment in patients with locally advanced or metastatic non-small-cell lung cancer harboring EGFR L858R mutation: a prospective, multicenter, phase II study (FIRM). (PubMed, Nat Commun)
    Baseline circulating tumor DNA (ctDNA) variant allele frequency predicts ctDNA clearance at cycle 3 day 1, which correlates with longer PFS. Double-dose firmonertinib shows promising efficacy and tolerability, supporting its preliminary potential as first-line treatment for EGFR L858R-mutated advanced NSCLC.
    P2 data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R
    |
    Ivesa (firmonertinib)
    18d
    Pulsatile High-dose Furmonertinib in EGFR-mutant NSCLC With Leptomeningeal Metastasis (clinicaltrials.gov)
    P=N/A, N=42, Not yet recruiting, Guangzhou University of Traditional Chinese Medicine
    New trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Ivesa (firmonertinib)