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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
    Stereotactic Body Radiotherapy With Sequential Iparomlimab and Tuvonralimab (QL1706) + Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Non-small-cell Lung Cancer in China (LUNG-Nanjing01): a Single-arm, Single-centre, Phase 2 Trial (clinicaltrials.gov)
    P2, N=24, Not yet recruiting, Jiangsu Cancer Institute & Hospital
    New P2 trial
    |
    Loqtorzi (toripalimab-tpzi) • Qibeian (iparomlimab/tuvonralimab)
    3d
    A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=220, Not yet recruiting, Nanjing Leads Biolabs Co.,Ltd
    New P1/2 trial
    |
    Loqtorzi (toripalimab-tpzi) • albumin-bound paclitaxel
    4d
    Neoadjuvant chemoradiotherapy plus programmed cell death protein-1 blockade versus chemoradiotherapy alone for muscle-invasive bladder cancer: a real-world comparative study. (PubMed, Front Immunol)
    Chemotherapy comprised gemcitabine 1,000 mg/m² (days 1 and 8) and cisplatin 70 mg/m² (days 2-3) every 21 days for ≥3 cycles...Toripalimab and tislelizumab achieved comparable PDRs (83.33% vs. 92.86%, p=0.613) and PCRRs (66.67% vs. 78.57%, p=0.694)...NACRT combined with PD-1 blockade significantly improved PCRR without increasing toxicity in patients with MIBC. These findings support conducting a prospective single-arm phase II multicenter trial to confirm potential long-term survival benefits.
    Clinical • Retrospective data • Journal • Real-world evidence
    |
    PD-1 (Programmed cell death 1)
    |
    cisplatin • gemcitabine • Loqtorzi (toripalimab-tpzi) • Tevimbra (tislelizumab-jsgr)
    5d
    A Phase II Study of Toripalimab Plus RC48-ADC With Radiotherapy for Bladder Preservation in HER2-Positive Muscle-Invasive Bladder Cancer (clinicaltrials.gov)
    P2, N=45, Not yet recruiting, Tongji Hospital
    New P2 trial
    |
    cisplatin • Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin)
    9d
    A Phase II Study of Toripalimab Plus Chemotherapy and Low-Dose Radiotherapy for Neoadjuvant Therapy-Refractory Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=48, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    Loqtorzi (toripalimab-tpzi)
    15d
    A Phase I Clinical Study of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab Injection in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=31, Terminated, Shanghai Junshi Bioscience Co., Ltd. | N=198 --> 31 | Recruiting --> Terminated; The trial was stopped early on the initiative of the sponsor on the basis of a change in the research and development strategy without safety concerns
    Enrollment change • Trial termination
    |
    Loqtorzi (toripalimab-tpzi) • tifcemalimab (TAB004)
    16d
    Toripalimab Combined With Anthracycline-free or Anthracycline-containing Chemotherapy as Neoadjuvant Chemotherapy for Early Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=216, Not yet recruiting, Henan Cancer Hospital
    New P2 trial
    |
    carboplatin • Loqtorzi (toripalimab-tpzi) • albumin-bound paclitaxel • cyclophosphamide • epirubicin
    16d
    JS004 Combined With Toripalimab and With Standard Chemotherapy Treat Patients With Advanced Lung Cancer (clinicaltrials.gov)
    P1/2, N=119, Completed, Shanghai Junshi Bioscience Co., Ltd. | Active, not recruiting --> Completed
    Trial completion
    |
    cisplatin • carboplatin • paclitaxel • docetaxel • Loqtorzi (toripalimab-tpzi) • pemetrexed • etoposide IV • tifcemalimab (TAB004)
    16d
    A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma. (clinicaltrials.gov)
    P1/2, N=202, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd.
    New P1/2 trial
    |
    cisplatin • Loqtorzi (toripalimab-tpzi) • YL201
    16d
    Disitamab vedotin (RC48-ADC) combined with immunotherapy as neoadjuvant therapy for localized muscle-invasive bladder cancer: a multicenter real-world study. (PubMed, NPJ Precis Oncol)
    Neoadjuvant cisplatin-based combination chemotherapy or perioperative durvalumab with neoadjuvant gemcitabine-cisplatin has been the primary treatment for localized muscle-invasive bladder cancer (MIBC)...Twenty-five patients (cT2-4aN0-2M0) received at least four cycles of RC48 (2.0 mg/kg, Q2W or Q3W) with toripalimab, tislelizumab, or pembrolizumab, followed by radical cystectomy...Treatment-related adverse events were manageable. These findings suggest that RC48 combined with PD-1 inhibitors is a promising neoadjuvant strategy for localized MIBC and warrants further validation in biomarker-selected populations.
    Journal • Real-world evidence • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression
    |
    Keytruda (pembrolizumab) • Imfinzi (durvalumab) • gemcitabine • Loqtorzi (toripalimab-tpzi) • Tevimbra (tislelizumab-jsgr) • Aidixi (disitamab vedotin)
    17d
    BCIRT-01: Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation (clinicaltrials.gov)
    P2, N=71, Active, not recruiting, Sun Yat-sen University | Trial primary completion date: Aug 2025 --> Dec 2025
    Trial primary completion date
    |
    cisplatin • carboplatin • gemcitabine • Loqtorzi (toripalimab-tpzi)
    18d
    Toripalimab and Penpulimab: Targeting PD-1 in Recurrent or Metastatic Nasopharyngeal Carcinoma. (PubMed, Ann Pharmacother)
    Toripalimab and penpulimab significantly improve outcomes in RM-NPC. Their use is anticipated to expand into additional settings and malignancies as research matures.
    Review • Journal
    |
    PD-1 (Programmed cell death 1)
    |
    cisplatin • carboplatin • Loqtorzi (toripalimab-tpzi) • Anniko (penpulimab)