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    DRUG:

    Loqtorzi (toripalimab-tpzi)

    i
    Other names: JS001, JS-001, JS 001, TAB-001, TAB001, terepril monoclonal antibody, treipril monoclonal antibody, TAB 001
    Company:
    Apotex, Coherus Oncology, Dr. Reddy’s, Excellmab, Hikma, LEO Pharma, Shanghai Junshi Biosci
    Drug class:
    PD1 inhibitor
    Related drugs:
    2d
    Efficacy and safety of toripalimab in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): a phase 1b/2 study. (PubMed, Signal Transduct Target Ther)
    Toripalimab combined with cetuximab demonstrated manageable safety and promising efficacy for R/M HNSCC, warranting further investigation. Clinical trial number: NCT04856631.
    P1/2 data • Journal
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    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • PD-L1 negative
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    Erbitux (cetuximab) • Loqtorzi (toripalimab-tpzi)
    5d
    HCHTOG2603: A Multicenter, Open-Label, Randomized Controlled Phase III Clinical Trial Comparing Surgery Versus Radical Chemoradiotherapy (Organ Preservation) in Patients With Thoracic Esophageal Squamous Cell Carcinoma Achieving cCR or cPR Following Neoadjuvant Immunochemotherapy (clinicaltrials.gov)
    P3, N=1044, Not yet recruiting, Henan Cancer Hospital
    New P3 trial
    |
    Loqtorzi (toripalimab-tpzi) • albumin-bound paclitaxel
    5d
    PTC-Guided Atorvastatin Plus Axitinib and Toripalimab in Advanced RCC (clinicaltrials.gov)
    P1/2, N=40, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New P1/2 trial
    |
    Loqtorzi (toripalimab-tpzi) • axitinib
    6d
    EDS01 HN: Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) for the Treatment of Recurrent or Metastatic Head and Neck Tumors (clinicaltrials.gov)
    P1, N=9, Recruiting, West China Hospital
    New P1 trial
    |
    Loqtorzi (toripalimab-tpzi)
    13d
    Safety and Clinical Outcomes of Kanglaite Injection in Combination with Toripalimab and Chemotherapy for Advanced Non-Small Cell Lung Cancer: A Real-World Retrospective Analysis. (PubMed, Cancer Manag Res)
    Dynamic changes in serum VEGF levels were associated with treatment response; however, these findings should be interpreted with caution due to the retrospective design and absence of a control group. Further well-designed prospective controlled studies are warranted to validate these observations.
    Clinical data • Retrospective data • Journal • Real-world evidence
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR wild-type • ALK wild-type
    |
    Loqtorzi (toripalimab-tpzi) • Kanglaite Injection (KLTi)
    13d
    REMEDY-RCC: Gut Microbiota Modulation for Immunotherapy Resensitization in Advanced Renal Cell Carcinoma (clinicaltrials.gov)
    P2, N=33, Not yet recruiting, Jinling Hospital, China
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Yervoy (ipilimumab) • Loqtorzi (toripalimab-tpzi)
    14d
    Neoadjuvant SF-SBRT Plus Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC. (clinicaltrials.gov)
    P3, N=201, Not yet recruiting, Shanghai Pulmonary Hospital, Shanghai, China
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    ALK rearrangement
    |
    cisplatin • carboplatin • docetaxel • Loqtorzi (toripalimab-tpzi) • albumin-bound paclitaxel
    14d
    HOPE-07-MIBC: Disitamab Vedotin Plus Immunotherapy vs Chemoimmunotherapy in Resectable HER2-Expressing MIBC (clinicaltrials.gov)
    P2/3, N=240, Not yet recruiting, West China Hospital
    New P2/3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 expression
    |
    cisplatin • gemcitabine • Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin)
    19d
    Metronomic Oral Paclitaxel Monotherapy and Combined Immunotherapy for Advanced HER2-Negative Breast Cancer: A Two-Stage Dose Exploration and Expansion Trial (clinicaltrials.gov)
    P2, N=44, Not yet recruiting, Zhejiang Cancer Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    paclitaxel • Loqtorzi (toripalimab-tpzi)
    21d
    Malignant reninoma with pulmonary metastasis and ATRX mutation treated with olaparib: a case report of specialized treatment. (PubMed, Front Immunol)
    The patient developed local recurrence and pancreatic head metastasis in January 2025, with stable disease achieved after radiotherapy, EP chemotherapy and toripalimab immunotherapy. Subsequent olaparib targeted therapy led to resolution of renal recurrent tumor, but progressive pancreatic lesion and persistent pulmonary metastasis were observed, suggesting tumor heterogeneity. This case demonstrates the value of NGS in screening actionable molecular targets for rare malignant reninoma; olaparib yields favorable local control for ATRX-mutated malignant reninoma based on synthetic lethality, while the differential response at metastatic sites underscores the need for exploring combination therapies to overcome tumor heterogeneity and drug resistance, providing a clinical reference for precision treatment of this rare disease.
    Journal • PARP Biomarker • IO biomarker
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    ATRX (ATRX Chromatin Remodeler)
    |
    Lynparza (olaparib) • Loqtorzi (toripalimab-tpzi)
    22d
    A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC) (clinicaltrials.gov)
    P2, N=64, Active, not recruiting, Lyvgen Biopharma Holdings Limited | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    paclitaxel • Loqtorzi (toripalimab-tpzi) • exlinkibart (LVGN6051)
    23d
    A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer (clinicaltrials.gov)
    P2, N=864, Recruiting, Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Loqtorzi (toripalimab-tpzi) • AWT020