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    DRUG:

    trastuzumab vedotin (MRG002)

    i
    Other names: MRG002
    Company:
    Lepu Med
    Drug class:
    Microtubule inhibitor, HER2-targeted antibody-drug conjugate
    Related drugs:
    30d
    Antibody-drug conjugates in patients with advanced/metastatic HER2-low-expressing breast cancer: a systematic review and meta-analysis. (PubMed, Ther Adv Med Oncol)
    Studies evaluating ADCs (trastuzumab deruxtecan (T-DXd), sacituzumab govitecan (SG), MRG002, and RC48-ADC) in patients with HER2-low a/mBC were included. Future studies should focus on bringing ADCs into earlier lines of therapy in this population. This study was registered in PROSPERO (CRD42024452962).
    Retrospective data • Review • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression • HER-2 underexpression
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Aidixi (disitamab vedotin) • Trodelvy (sacituzumab govitecan-hziy) • trastuzumab vedotin (MRG002)
    2ms
    MRG002-101: A Study of MRG002 in Patients with HER2-Positive Advanced Solid Tumors and Locally Advanced or Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer (clinicaltrials.gov)
    P1/2, N=129, Active, not recruiting, Shanghai Miracogen Inc. | Recruiting --> Active, not recruiting | Trial completion date: Aug 2023 --> Dec 2024
    Enrollment closed • Trial completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    trastuzumab vedotin (MRG002)
    over1year
    A Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov)
    P3, N=290, Recruiting, Shanghai Miracogen Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    gemcitabine • paclitaxel • docetaxel • pemetrexed • trastuzumab vedotin (MRG002)
    almost2years
    Safety, tolerability, pharmacokinetics, and antitumor activity of SHR-A1811 in HER2-expressing/mutated advanced solid tumors: A global phase 1, multi-center, first-in-human study (AACR 2023)
    Background: SHR-A1811 is an ADC comprised of a humanized anti-HER2 monoclonal antibody (trastuzumab), a cleavable linker, and a DNA topoisomerase I inhibitor payload. SHR-A1811 was well-tolerated and showed promising antitumor activity in heavily pretreated advanced solid tumors.Table 1. Subgroup analyses of ORRNo. of prior treatment lines in metastatic setting in all pts (N=250)HER2 positive BC (N=108)HER2-low BC (N=77)Other tumor types (N=65)≤381.8% (45/55)58.7% (27/46)36.7% (18/49)>381.1% (43/53)51.6% (16/31)31.3% (5/16)Prior anti-HER2 therapies in pts with BC (N=185)*HER2 positive BC (N=108)HER2-low BC (N=77)All BC (N=185)Any82.2% (88/107, 73.7-89.0)68.8% (11/16, 41.3-89.0)80.5% (99/123, 72.4-87.1)Trastuzumab81.9% (86/105, 73.2-88.7)75.0% (9/12, 42.8-94.5)81.2% (95/117, 72.9-87.8)Pertuzumab83.0% (39/47, 69.2-92.4)100% (5/5, 47.8-100)84.6% (44/52, 71.9-93.1)Pyrotinib86.9% (53/61, 75.8-94.1)71.4% (5/7, 29.0-96.3)85.3% (58/68, 74.6-92.7)Lapatinib80.0% (28/35, 63.1-91.6)100% (1/1, 2.5-100)80.6% (29/36, 64.0-91.8)T-DM182.4% (14/17, 56.6-96.2)100% (3/3, 29.2-100)85.0% (17/20, 62.1-96.8)Other HER2-ADC (except T-DM1)**60.0% (9/15, 32.3-83.7)50.0% (2/4, 6.8-93.2)57.9% (11/19, 33.5-79.8)ORR in pts with tumor types other than BC (N=65)HER2 IHC3+ or IHC2+/ISH+ (N=36)HER2 IHC2+/ISH- or IHC1+ or unknown (N=29)All other tumor types (N=65)% (n/N)38.9% (14/36)31.0% (9/29)35.4% (23/65)ORR was shown as % (n/N, 95% CI) or % (n/N).
    Clinical • P1 data • PK/PD data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 mutation • HER-2 expression • HER-2 underexpression
    |
    lapatinib • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • Irene (pyrotinib) • Aidixi (disitamab vedotin) • trastuzumab rezetecan (SHR-A1811) • anvatabart opadotin (JNJ-0683) • trastuzumab botidotin (A166) • PF-06804103 • trastuzumab vedotin (MRG002) • trastuzumab envedotin (DP303c) • BAT8001 • TAA013 • DX126-262
    almost2years
    A Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov)
    P3, N=290, Not yet recruiting, Shanghai Miracogen Inc.
    New P3 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    gemcitabine • paclitaxel • docetaxel • pemetrexed • trastuzumab vedotin (MRG002)
    over2years
    A Study of MRG002 in the Treatment of Patients With HER2-expressed Advanced Malignant Solid Tumors. (clinicaltrials.gov)
    P1/2, N=30, Recruiting, Shanghai Miracogen Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    Puyouheng (pucotenlimab) • trastuzumab vedotin (MRG002)
    over2years
    A Study of MRG002 in the Treatment of Patients With HER2-positive Breast Cancer With Liver Metastases. (clinicaltrials.gov)
    P2, N=99, Recruiting, Shanghai Miracogen Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    trastuzumab vedotin (MRG002)
    over2years
    A Study of MRG002 in the Treatment of Patients With HER2-expressed Advanced Malignant Solid Tumors. (clinicaltrials.gov)
    P1/2, N=30, Not yet recruiting, Shanghai Miracogen Inc.
    New P1/2 trial • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    Puyouheng (pucotenlimab) • trastuzumab vedotin (MRG002)
    almost3years
    Antibody-Drug Conjugates Targeting the Human Epidermal Growth Factor Receptor Family in Cancers. (PubMed, Front Mol Biosci)
    A third HER2-directed ADC, disitamab vedotin (RC48), has been approved for locally advanced or metastatic gastric or gastroesophageal junction cancer by the NMPA (National Medical Products Administration) of China in 2021. In this review article, we summarize the three approved ADCs (T-DM1, DS-8201a and RC48), together with the investigational EGFR-directed ADCs (ABT-414, MRG003 and M1231), HER2-directed ADCs (SYD985, ARX-788, A166, MRG002, ALT-P7, GQ1001 and SBT6050) and HER3-directed ADC (U3-1402). Lastly, we discuss the major challenges associated with the development of ADCs, and highlight the possible future directions to tackle these challenges.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • ERBB4 (erb-b2 receptor tyrosine kinase 4)
    |
    HER-2 positive
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • patritumab deruxtecan (U3-1402) • Aidixi (disitamab vedotin) • anvatabart opadotin (JNJ-0683) • Jivadco (trastuzumab duocarmazine) • MRG003 • trastuzumab botidotin (A166) • pertuzumab zuvotolimod (SBT6050) • M1231 • depatuxizumab mafodotin (ABT-414) • trastuzumab vedotin (MRG002) • ALT-P7 • GQ1001
    almost3years
    A Study of MRG002 in the Treatment of Patients With HER2-positive Breast Cancer With Liver Metastases. (clinicaltrials.gov)
    P2, N=99, Not yet recruiting, Shanghai Miracogen Inc.
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    trastuzumab vedotin (MRG002)
    3years
    A Study of MRG002 in the Treatment of Patients With HER2-positive Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=74, Recruiting, Shanghai Miracogen Inc. | Trial completion date: Dec 2021 --> Oct 2022 | Trial primary completion date: Aug 2021 --> Oct 2022
    Clinical • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    trastuzumab vedotin (MRG002)
    3years
    A Study of MRG002 in the Treatment of Patients With HER2-mutated Unresectable/Metastatic Non-small Cell Lung Cancer (NSCLC). (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, Shanghai Miracogen Inc.
    Clinical • New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 mutation
    |
    trastuzumab vedotin (MRG002)
    over3years
    A Study of MRG002 in the Treatment of HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=86, Recruiting, Shanghai Miracogen Inc. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    trastuzumab vedotin (MRG002)
    over3years
    A Study of MRG002 in Patients With HER2-Positive Advanced Solid Tumors and Locally Advanced or Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer (clinicaltrials.gov)
    P1/2, N=152, Recruiting, Shanghai Miracogen Inc. | Initiation date: Aug 2020 --> May 2021
    Clinical • Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    trastuzumab vedotin (MRG002)
    over3years
    A Study of MRG002 in the Treatment of Patients With HER2-positive Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=74, Recruiting, Shanghai Miracogen Inc.
    Clinical • New P1 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    trastuzumab vedotin (MRG002)
    over3years
    A Study of MRG002 in the Treatment of HER2-positive Unresectable Locally Advanced or Metastatic Urothelium Cancer (clinicaltrials.gov)
    P2, N=58, Recruiting, Shanghai Miracogen Inc. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    trastuzumab vedotin (MRG002)
    over3years
    A Study of MRG002 in the Treatment of HER2-positive Unresectable Locally Advanced or Metastatic Urothelium Cancer (clinicaltrials.gov)
    P2, N=58, Not yet recruiting, Shanghai Miracogen Inc.
    Clinical • New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    trastuzumab vedotin (MRG002)
    over3years
    A Study of MRG002 in the Treatment of HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=86, Not yet recruiting, Shanghai Miracogen Inc.
    Clinical • New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    trastuzumab vedotin (MRG002)
    over4years
    A Study of MRG002 in Patients With HER2-Positive Advanced Solid Tumors and Locally Advanced or Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer (clinicaltrials.gov)
    P1/2, N=152, Recruiting, Shanghai Miracogen Inc.
    Clinical • New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    trastuzumab vedotin (MRG002)