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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:
    1d
    EC-CRT-008: Consolidation of Toripalimab and Capecitabine After Chemoradiotherapy in ESCC (clinicaltrials.gov)
    P3, N=242, Recruiting, Sun Yat-sen University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1)
    |
    Loqtorzi (toripalimab-tpzi) • capecitabine
    1d
    FACT-TN: FMD and Neoadjuvant Chemo-immunotherapy in TNBC (clinicaltrials.gov)
    P2, N=80, Recruiting, Sun Yat-sen University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • HER-2 negative + ER positive • HER-2 negative + HR negative
    |
    docetaxel • Loqtorzi (toripalimab-tpzi) • doxorubicin hydrochloride • albumin-bound paclitaxel • cyclophosphamide • epirubicin
    1d
    2025-370: A Multicohort Study of Toripalimab in Combination With Investigator-Selected Chemotherapy for Advanced HER2-Negative Breast Cancer (clinicaltrials.gov)
    P2, N=92, Recruiting, Henan Cancer Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    Loqtorzi (toripalimab-tpzi)
    2d
    RCT of GAPP Induction and Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced NPC. (clinicaltrials.gov)
    P3, N=442, Not yet recruiting, Sun Yat-sen University
    New P3 trial
    |
    cisplatin • gemcitabine • Focus V (anlotinib) • Loqtorzi (toripalimab-tpzi)
    2d
    Toripalimab as Monotherapy in Participants With POLE or POLD-1 Mutated and Non-MSI-H Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=35, Recruiting, Sun Yat-sen University | Trial completion date: Jan 2024 --> Dec 2029 | Trial primary completion date: Jan 2024 --> Jan 2028
    Trial completion date • Trial primary completion date • Tumor mutational burden • IO biomarker • MSI-H
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability) • POLE (DNA Polymerase Epsilon) • POLD1 (DNA Polymerase Delta 1)
    |
    POLE mutation • POLD1 mutation
    |
    Loqtorzi (toripalimab-tpzi)
    5d
    Case Report: A rare case of Pneumocystis jirovecii infection with left hydropneumothorax following immunotherapy for stage IVB clear cell renal cell carcinoma. (PubMed, Front Med (Lausanne))
    After receiving targeted combination immunotherapy with sequential PD-1 inhibitors (toripalimab) plus anti-angiogenic agents (sunitinib, axitinib)-a regimen that enhances anti-tumor immunity but may disrupt pulmonary immune homeostasis-the patient gradually developed progressive dyspnea, chest tightness, hypoxemia, and anuria. Although PJP complicated by hydropneumothorax after immunotherapy is rare, it should be considered as a possible etiology when cancer patients develop progressive dyspnea with difficulty maintaining oxygen saturation after receiving immune checkpoint inhibitor-based therapy, particularly in the context of immune checkpoint inhibitor use. While biomarkers for predicting immunotherapy efficacy and irAEs are well-studied, the identification of specific biomarkers for predicting opportunistic infections like PJP in this context remains an area of active research.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD4 (CD4 Molecule)
    |
    sunitinib • Loqtorzi (toripalimab-tpzi) • axitinib
    5d
    Redefining standards: a comprehensive systematic review of practice changing advances in GU oncology from ASCO and ESMO 2025. (PubMed, Front Endocrinol (Lausanne))
    Key advances include: (1) In bladder cancer, perioperative durvalumab (NIAGARA) and enfortumab vedotin plus pembrolizumab (KEYNOTE-905/EV-303) set new standards, while HER2-targeted disitamab vedotin plus toripalimab (RC48-C016) improved metastatic survival...(3) In prostate cancer, enzalutamide plus leuprolide improved survival in high-risk biochemical recurrence (EMBARK). Capivasertib plus abiraterone benefited PTEN-deficient metastatic hormone-sensitive disease (CAPItello-281). The PSMAddition trial demonstrated that adding [177Lu]Lu-PSMA-617 to standard therapy significantly improved radiographic PFS in PSMA-positive mHSPC. Docetaxel scheduling was optimized (ARASAFE), and an AI model (STAMPEDE) identified patients for AR inhibitor benefit. Novel agents like saruparib and pasritamig showed promise...The 2025 evidence establishes multiple new standards of care across GU cancers, emphasizing biomarker-driven strategies, immunotherapy integration, novel resistance mechanisms, and treatment optimization. This synthesis provides an evidence-based framework for updating guidelines and highlights the move toward more personalized management, while noting persistent challenges and future research needs.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PTEN (Phosphatase and tensin homolog)
    |
    FOLH1 positive
    |
    Keytruda (pembrolizumab) • Imfinzi (durvalumab) • docetaxel • Loqtorzi (toripalimab-tpzi) • Xtandi (enzalutamide) • abiraterone acetate • Truqap (capivasertib) • Aidixi (disitamab vedotin) • Padcev (enfortumab vedotin-ejfv) • saruparib (AZD5305) • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • leuprolide acetate for depot suspension • pasritamig (JNJ-8343)
    6d
    TORCHLIGHT: Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment (clinicaltrials.gov)
    P3, N=531, Completed, Shanghai Junshi Bioscience Co., Ltd. | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER negative
    |
    Loqtorzi (toripalimab-tpzi) • albumin-bound paclitaxel
    9d
    LIGHT: LDRT Combined With Toripalimab and Chemotherapy for Recurrent/Metastatic NPC (clinicaltrials.gov)
    P2, N=55, Recruiting, Sun Yat-sen University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cisplatin • gemcitabine • Loqtorzi (toripalimab-tpzi)
    9d
    CHS-388-202: A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepatocellular Carcinoma (clinicaltrials.gov)
    P2, N=72, Active, not recruiting, Coherus Oncology, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Avastin (bevacizumab) • Loqtorzi (toripalimab-tpzi) • casdozokitug (CHS-388)
    13d
    Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacokinetics, and Preliminary Efficacy of FS-8002 (clinicaltrials.gov)
    P1, N=66, Recruiting, Shanghai Pushi Medical Science Co. Ltd | Trial completion date: Sep 2026 --> Feb 2028 | Trial primary completion date: Sep 2026 --> Feb 2028
    Trial completion date • Trial primary completion date
    |
    Loqtorzi (toripalimab-tpzi)
    16d
    STC-15-24202: STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas (clinicaltrials.gov)
    P1/2, N=107, Recruiting, STORM Therapeutics LTD | N=188 --> 107 | Trial completion date: Jun 2027 --> Jun 2028 | Trial primary completion date: Dec 2026 --> Dec 2027
    Enrollment change • Trial completion date • Trial primary completion date
    |
    Loqtorzi (toripalimab-tpzi) • STC-15