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    DRUG:

    FHND9041

    i
    Other names: FHND9041, FHND-9041, FHND 9041
    Associations

    News

    Trials
    Company:
    Sino Biopharm
    Drug class:
    EGFR inhibitor
    Related drugs:
    Associations

    News

    Trials
    4ms
    Comprehensive first-in-human phase I/II study of FHND-9041 in patients with EGFR-mutated advanced non-small cell lung cancer. (PubMed, Lung Cancer)
    FHND-9041 exhibits favorable safety and efficacy profile, supporting its further clinical development for EGFR-mutated advanced NSCLC.
    P1/2 data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M • EGFR positive
    |
    FHND9041
    11ms
    FHND9041 Versus Afatinib for Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=350, Enrolling by invitation, Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
    New P3 trial
    |
    Gilotrif (afatinib) • FHND9041
    over1year
    Helpful: First-in-Human Phase I/II Study of FHND-9041 in Patients With EGFR Mutated Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=124, Completed, Yongchang Zhang
    New P1/2 trial • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    FHND9041
    over2years
    Safety, efficacy, and tolerability of FHND9041 capsules as first-line treatment in patients with EGFR sensitive mutations or second/ third-line treatment in patients with T790M+ advanced non-small cell lung cancer (NSCLC): results from a phase I/II single-arm, multi-center, open-label study (AACR 2023)
    FHND9041 capsule 80 mg shows significant antitumor activity with favorable efficacy and safety profile in patients for both initial treatment and treatment of T790M+ NSCLC who progressed after prior therapy. For futher research of the capsule, a multicenter, randomized, positive-controlled phase III clinical research is ongoing with recommended dose of 80 mg.GroupDosage(mg)Evaluable Subjects(n)ORR%Second/Third-line T790M+40mg333.3380mg3963.64120mg4258.33180mg3100.00First-line80mg3771.43
    Clinical • P1/2 data • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR T790M
    |
    FHND9041