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    DRUG:

    trastuzumab rezetecan (SHR-A1811)

    i
    Other names: SHR-A1811, SHRA1811, SHR A1811, SHR-1811, SHR1811, SHR 1811
    Company:
    Glenmark, Jiangsu Hengrui Pharma
    Drug class:
    Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate
    Related drugs:
    1m
    A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer (clinicaltrials.gov)
    P3, N=1000, Not yet recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd.
    New P3 trial
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • capecitabine • trastuzumab rezetecan (SHR-A1811) • AiRuiLi (adebrelimab)
    1m
    Trastuzumab rezetecan versus pyrotinib plus capecitabine for patients with HER2-positive metastatic breast cancer (HORIZON-Breast01): interim analysis of a multicentre, open-label, randomised, controlled, phase 3 trial. (PubMed, Lancet Oncol)
    Trastuzumab rezetecan improved progression-free survival versus pyrotinib plus capecitabine and showed a distinct safety profile in patients with HER2-positive breast cancer, presenting as a potential new treatment option.
    P3 data • P3 data: top line • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • capecitabine • Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811)
    1m
    A Randomized, Open-Label, Controlled, Multicenter Phase III Clinical Study of SHR-A1811 in Combination With Chemotherapy and Bevacizumab Versus Standard Therapy as First-Line Treatment for Advanced Colorectal Cancer (clinicaltrials.gov)
    P3, N=300, Not yet recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd.
    New P3 trial
    |
    Avastin (bevacizumab) • 5-fluorouracil • oxaliplatin • trastuzumab rezetecan (SHR-A1811) • leucovorin calcium • levoleucovorin calcium
    1m
    SHR-A1811-305: A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy (clinicaltrials.gov)
    P3, N=1615, Active, not recruiting, Jiangsu HengRui Medicine Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • HR positive
    |
    Kadcyla (ado-trastuzumab emtansine) • trastuzumab rezetecan (SHR-A1811)
    1m
    A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor (clinicaltrials.gov)
    P1/2, N=120, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • capecitabine • albumin-bound paclitaxel • trastuzumab rezetecan (SHR-A1811)
    1m
    Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib as First-Line Therapy for Advanced HER2-Positive/HER2-Low Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=70, Recruiting, Peking Union Medical College Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression • HER-2 underexpression
    |
    Herceptin (trastuzumab) • Lenvima (lenvatinib) • trastuzumab rezetecan (SHR-A1811) • AiRuiLi (adebrelimab)
    1m
    TRIBE: An Open-Label, Randomized Phase III Study of Trastuzumab Rezetecan With or Without Bevacizumab in First to Third Line BLIS Subtype TNBC (clinicaltrials.gov)
    P3, N=140, Not yet recruiting, Fudan University
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • ER negative
    |
    Avastin (bevacizumab) • Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811)
    2ms
    Trastuzumab Rezetecan Neoadjuvant Therapy in THP-Insensitive HER2-Positive Early Breast Cancer (clinicaltrials.gov)
    P2, N=124, Recruiting, The First Affiliated Hospital of Soochow University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • trastuzumab rezetecan (SHR-A1811)
    2ms
    HER2 Therapies in Non-Small Cell Lung Cancer (NSCLC). (PubMed, Int J Mol Sci)
    Concerning treatment, in advanced HER2-positive, Non-Squamous NSCLC tumors, the first-line treatment is Platinum-based + Pemetrexed chemotherapy, with or without immunotherapy, because no HER2-targeted antibody therapy has yet been approved for initial treatment. After progression, HER2-targeted antibody-drug conjugates like Trastuzumab-Deruxtecan and Ado Trastuzumab-Emtansine may offer patients clinical benefits. New HER2-selective tyrosine kinase inhibitors, such as zongertinib and sevabertinib, have shown promising results, including patients previously treated with antibody-drug conjugates (ADCs). Recent advances, including next-generation ADCs such as SHR-A1811 and A166, and bispecific antibodies, such as zenocutuzumab for NRG1 fusion-positive disease, which are also expanding treatment options. Overall, advances in diagnostics and new targeted therapies are changing how HER2-altered NSCLC is treated and are helping to make care more personalized.
    Review • Journal • IO biomarker
    |
    NRG1 (Neuregulin 1)
    |
    HER-2 positive • HER-2 mutation • HER-2 expression • NRG1 fusion • HER-2 exon 20 mutation
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • pemetrexed • Bizengri (zenocutuzumab-zbco) • trastuzumab rezetecan (SHR-A1811) • Hernexeos (zongertinib) • Sertaly (trastuzumab botidotin) • Hyrnuo (sevabertinib)
    2ms
    Multi-Omics-Based Phase Ⅱ Trial of Trastuzumab Rezetecan Plus Camrelizumab for Perioperative Therapy in HER2-Positive Muscle-Invasive Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=44, Not yet recruiting, Sheng Tai
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • AiRuiKa (camrelizumab) • trastuzumab rezetecan (SHR-A1811)
    2ms
    Efficacy and Safety of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    New P2 trial
    |
    HER-2 positive
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • trastuzumab rezetecan (SHR-A1811)
    2ms
    Trastuzumab Rezetecan(SHR-A1811) Combined With Ivonescimab (AK112) in Locally Advanced or Metastatic Non-small Cell Lung Cancer Harboring HER2 Gene Abnormalities (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Sun Yat-sen University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 overexpression • HER-2 amplification
    |
    Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811) • Idafang (ivonescimab)