^
    1year
    FURMO-002: Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations (clinicaltrials.gov)
    P1, N=170, Recruiting, ArriVent BioPharma, Inc.
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 exon 20 insertion • EGFR G719X • EGFR S768I • EGFR G724S • HER-2 exon 23 mutation • EGFR R776C • EGFR V774M
    |
    Ivesa (firmonertinib)
    1year
    FURMO-002: Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations (clinicaltrials.gov)
    P1, N=170, Recruiting, ArriVent BioPharma, Inc. | Phase classification: P1b --> P1
    Phase classification • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 exon 20 insertion • EGFR G719X • EGFR S768I • EGFR G724S • HER-2 exon 23 mutation • EGFR R776C • EGFR V774M
    |
    Ivesa (firmonertinib)
    over1year
    Safety and Efficacy of Aumolertinib in Patients with advanced NSCLC Harboring Uncommon EGFR Mutations: Cohort 2 Updated (IASLC-WCLC 2023)
    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).
    Clinical • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L861Q • EGFR G719X • EGFR S768I • EGFR L747P • EGFR H773L • EGFR V774M
    |
    Ameile (aumolertinib)
    over1year
    Exceptional Response to Aumolertinib in an Advanced NSCLC Patient With Rare EGFR Exon20 V774M and S768I Mutations (IASLC-WCLC 2023)
    The second-generation EGFR-TKI afatinib has been shown to be effective against complex rare EGFR mutations like H773L/V774M or G719X/S768I, meanwhile more adverse effects such as diarrhea and rash occur...Telephone follow-up revealed that the patient continued to take aumolertinib in combination with anlotinib until her death in July 2022... A previous report indicated that patients harboring two uncommon mutations were associated with poorer prognosis (mPFS: 6.5 months). However, the AIM study, recently published in ESMO ASIA 2022, demonstrated that aumolertinib had an impressive objective response rate (ORR) of 53.8% and disease control rate (DCR) of 100% in patients with the main rare mutations (G719X/L861Q/S768I). In summary, this case report suggests that EGFR V774M/S768I can be an activating mutation complex and the administration of aumolertinib monotherapy or a combination with anti-angiogenic drug can achieve outstanding clinical benefits for these patients.
    Clinical • EGFR exon 20 • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR exon 20 insertion • EGFR L861Q • EGFR G719X • EGFR S768I • EGFR exon 20 mutation • EGFR exon 20 mutation + EGFR V774M + EGFR S768I • EGFR H773L • EGFR V774M
    |
    Gilotrif (afatinib) • Focus V (anlotinib) • Ameile (aumolertinib)
    2years
    FURMO-002: Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer With Activating EGFR or HER2 Mutations (clinicaltrials.gov)
    P1b, N=170, Recruiting, ArriVent BioPharma, Inc. | N=108 --> 170
    Enrollment change • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • HER-2 exon 20 insertion • EGFR G719X • EGFR S768I • HER-2 exon 23 mutation • EGFR V774M
    |
    Ivesa (firmonertinib)
    2years
    Safety and efficacy of aumolertinib treatment in patients with advanced NSCLC harboring uncommon EGFR mutations: Cohort 2 (ESMO Asia 2022)
    The up to date data suggested CK Increase was positively associated with the efficacy of Aumolertinib. On the other hand, Aumolertinib in G719X&L861Q&S768I genotypes showed better outcome compared to other genotypes.
    Clinical
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR L861Q • EGFR G719X • EGFR S768I • EGFR L747P • EGFR V774M
    |
    Ameile (aumolertinib)
    over2years
    A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies (clinicaltrials.gov)
    P2, N=1, Terminated, Spectrum Pharmaceuticals, Inc | N=150 --> 1 | Trial completion date: Dec 2023 --> Mar 2022 | Recruiting --> Terminated | Trial primary completion date: Jun 2023 --> Mar 2022; Strategic business decision (unrelated to safety)
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • MSI (Microsatellite instability)
    |
    HER-2 positive • EGFR mutation • MSI-H/dMMR • HER-2 negative • EGFR L858R • HER-2 exon 20 insertion • EGFR L861Q • EGFR G719X • ER negative • EGFR S768I • HER-2 S310F • EGFR positive • HER-2 I655V • HER-2 L869R • HER-2 V842I • EGFR P596L • EGFR R222C • EGFR A750P • EGFR E746 • EGFR L833V • HER-2 R678Q • PGR negative • EGFR V774M
    |
    Pozenveo (poziotinib) • loperamide
    over2years
    The landscape of EGFR mutation in Chinese patients with glioma. (ASCO 2022)
    EGFR amplification was the most common mutation type. There were 122 SNV and Indel subtypes altogether and occurred throughout almost the entire exon region, in which exon7 contained maximum 21 different subtypes and the p.A289V was the main type. The distribution of subtypes in ECD were much more than in ICD.
    Clinical
    |
    EGFR (Epidermal growth factor receptor) • SEC61G (SEC61 Translocon Subunit Gamma)
    |
    EGFR mutation • EGFR T790M • EGFR amplification • EGFR G719A • EGFR A289V • EGFR fusion • EGFR V774M
    3years
    Identification of the Unique Clinical and Genetic Features of Chinese Lung Cancer Patients With EGFR Germline Mutations in a Large-Scale Retrospective Study. (PubMed, Front Oncol)
    A total of 19 patients were confirmed to have received EGFR tyrosine kinase inhibitors (TKIs), but the response to EGFR-TKIs differed among patients with different EGFR mutations. Chinese patients with lung cancer harbored unique and dispersive EGFR germline mutations and showed unique clinical and genetic characteristics, with varied response patterns to EGFR-TKI treatment.
    Retrospective data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR K757R • EGFR R776H • EGFR V774M
    almost5years
    A Study of Poziotinib in Patients With EGFR or HER2 Activating Mutations in Advanced Malignancies (clinicaltrials.gov)
    P2, N=150, Recruiting, Spectrum Pharmaceuticals, Inc | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • HER-2 amplification • EGFR L858R • HER-2 mutation • EGFR T790M • HER-2 exon 20 insertion • EGFR L861Q • EGFR G719X • EGFR S768I • HER-2 S310F • HER-2 V777L • EGFR E709K • HER-2 I655V • HER-2 L869R • HER-2 V842I • EGFR P596L • EGFR R222C • HER-2 T798M • EGFR E746 • HER-2 D769H • HER-2 R678Q • HER-2 T798I • HER-2 mutation + HER-2 T798I • EGFR V774M
    |
    Pozenveo (poziotinib)