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    DRUG:

    sacibertinib (Hemay022)

    i
    Other names: Hemay022
    Company:
    Tianjin Hemay Pharma
    Drug class:
    EGFR inhibitor
    Related drugs:
    8ms
    A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=339, Recruiting, Tianjin Hemay Pharmaceutical Co., Ltd
    New P3 trial • Combination therapy • Metastases
    |
    Herceptin (trastuzumab) • lapatinib • capecitabine • sacibertinib (Hemay022)
    9ms
    A phase I study of Hemay022, an irreversible dual EGFR/HER2 tyrosine kinase inhibitor in Chinese patients with HER2-positive advanced breast cancer. (PubMed, Chin J Cancer Res)
    The pharmacokinetic properties and encouraging anti-tumor activities of Hemay022 in advanced breast cancer patients warranted further evaluation of Hemay022 for treating breast cancer patients in the current phase III trial (No. NCT05122494).
    P1 data • Journal • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    sacibertinib (Hemay022)
    9ms
    Study Evaluating Hemay022 in Combination With Endocrine Therapy In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=55, Completed, Tianjin Hemay Pharmaceutical Co., Ltd | Recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 overexpression
    |
    fulvestrant • letrozole • exemestane • sacibertinib (Hemay022)
    9ms
    Study Evaluating Hemay022 In Subjects With HER2-Positive Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=28, Completed, Tianjin Hemay Pharmaceutical Co., Ltd | Unknown status --> Completed | N=57 --> 28 | Trial completion date: Dec 2018 --> Sep 2023 | Trial primary completion date: Dec 2018 --> Sep 2023
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression
    |
    sacibertinib (Hemay022)
    1year
    Antitumor activity and safety of sacibertinib (Hemay022) in combination with endocrine therapy in patients with ER and HER2 both positive metastatic breast cancer: A phase Ib study (SABCS 2023)
    This study aimed to explore the safety and efficacy of sacibertinib plus endocrine therapy in patients with estrogen receptor-positive ( PATIENTS AND METHODS Using a phase 1b 3+3 dose escalation and expansion study design, patients with ER+/ HER2+ MBC were treated with sacibertinib (200mg-500mg daily) plus endocrine therapy including exemestane, letrozole, fulvestrant. CONCLUSION Sacibertinib plus endocrine therapy had a favorable safety profile and antitumor activity in patients with ER+/ HER2+ MBC, 400-500mg daily showed more efficacy, supporting further assessment in randomized studies. This figure showed response of Sacibertinib plus endocrine therapy in ER+/ HER2+ metastatic breast cancer.
    Clinical • P1 data • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive
    |
    fulvestrant • letrozole • sacibertinib (Hemay022)
    1year
    Antitumor efficacy and safety of sacibertinib (Hemay022) in combination with endocrine therapy in patients with ER+ and HER2+ metastatic breast cancer: A phase Ib study (SABCS 2023)
    PATIENTS AND METHODS Using a phase 1b 3+3 dose escalation and expansion study design, patients with ER+/ HER2+ MBC were treated with sacibertinib (200mg-500mg daily) plus endocrine therapy including exemestane, letrozole, fulvestrant . Summary of efficacy data(EAS) NOTE. NA, not available (because cannot be calculated) Treatment-Emergent Adverse Events Occurring in ≥ 10% of Patients in the Safety Population Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; Waterfall plot of best change rate in target-lesion size from baseline
    Clinical • P1 data • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 positive • ER positive
    |
    fulvestrant • letrozole • sacibertinib (Hemay022)
    over2years
    Fillful-03: A Phase Ⅲ Study of the Efficacy and Safety of Hemay022+Aromatase Inhibitor(AI) in Participants With ER+/HER2+ Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=339, Recruiting, Tianjin Hemay Oncology Pharmaceutical Co., Ltd | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 overexpression
    |
    Herceptin (trastuzumab) • lapatinib • capecitabine • sacibertinib (Hemay022)
    3years
    A Phase Ⅲ Study of the Efficacy and Safety of Hemay022+Aromatase Inhibitor(AI) in Participants With ER+/HER2+ Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=339, Not yet recruiting, Tianjin Hemay Oncology Pharmaceutical Co., Ltd
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 overexpression
    |
    Herceptin (trastuzumab) • lapatinib • capecitabine • sacibertinib (Hemay022)
    over3years
    Study Evaluating Hemay022 in Combination With Endocrine Therapy In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=48, Recruiting, Tianjin Hemay Pharmaceutical Co.,Ltd | Trial completion date: Jul 2021 --> Dec 2022 | Trial primary completion date: Feb 2021 --> May 2022
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 overexpression
    |
    fulvestrant • letrozole • exemestane • sacibertinib (Hemay022)
    almost4years
    Study Evaluating Hemay022 in Combination With Endocrine Therapy In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=48, Recruiting, Tianjin Hemay Pharmaceutical Co.,Ltd | Trial completion date: Jul 2019 --> Jul 2021 | Trial primary completion date: Mar 2019 --> Feb 2021
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 overexpression
    |
    fulvestrant • letrozole • exemestane • sacibertinib (Hemay022)