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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 Biosci, Dr. Reddy’s, Excellmab, Hikma, Shanghai Junshi Biosci
    Drug class:
    PD1 inhibitor
    Related drugs:
    1d
    Toripalimab Plus Chemotherapy as a First-Line Therapy for Extensive-Stage Small Cell Lung Cancer: The Phase 3 EXTENTORCH Randomized Clinical Trial. (PubMed, JAMA Oncol)
    To evaluate the efficacy and safety of toripalimab plus etoposide and platinum-based chemotherapy (EP) vs placebo plus EP as a first-line treatment for patients with ES-SCLC. The treatment exhibited an acceptable safety profile, supporting this combination regimen as a new treatment option for patients with ES-SCLC. ClinicalTrials.gov Identifier: NCT04012606.
    Clinical • P3 data • Journal
    |
    KMT2D (Lysine Methyltransferase 2D)
    |
    HLA-A*11
    |
    Loqtorzi (toripalimab-tpzi) • etoposide IV
    3d
    Combination of Toripalimab and JS004 Therapy for ccRCC (clinicaltrials.gov)
    P2, N=80, Recruiting, Fudan University
    New P2 trial • Metastases
    |
    sorafenib • Loqtorzi (toripalimab-tpzi) • Inlyta (axitinib) • tifcemalimab (TAB004)
    3d
    Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer (NEOTORCH-BREAST01) (clinicaltrials.gov)
    P2, N=30, Recruiting, First Affiliated Hospital of Zhejiang University | N=50 --> 30 | Trial completion date: Oct 2029 --> Jun 2029 | Initiation date: Oct 2024 --> Jun 2024 | Trial primary completion date: Oct 2026 --> Jun 2026
    Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    paclitaxel • Loqtorzi (toripalimab-tpzi) • cyclophosphamide • epirubicin
    6d
    Neoadjuvant Chemotherapy Combined With Toripalimab for TNBC (NEOTORCH-BREAST02) (clinicaltrials.gov)
    P2, N=35, Recruiting, First Affiliated Hospital of Zhejiang University
    New P2 trial
    |
    Loqtorzi (toripalimab-tpzi) • albumin-bound paclitaxel • cyclophosphamide • epirubicin
    6d
    A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours (clinicaltrials.gov)
    P1/2, N=320, Not yet recruiting, LaNova Medicines Limited
    New P1/2 trial • Combination therapy • Metastases
    |
    carboplatin • docetaxel • Lenvima (lenvatinib) • Loqtorzi (toripalimab-tpzi) • Tevimbra (tislelizumab-jsgr) • Zejula (niraparib)
    8d
    An open-label, multicenter Phase 2 single-arm, study to assessing the efficacy and safety of DNV3 in combination with toripalimab and chemotherapy in patients with locally advanced unresectable or metastatic melanoma following failure of prior treatment with immune checkpoint inhibitors (ChiCTR2400091269)
    P2, N=60, Not yet recruiting, Fujian Cancer Hospital; Fujian Cancer Hospital
    New P2 trial • Combination therapy • Checkpoint inhibition • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Loqtorzi (toripalimab-tpzi)
    8d
    Phase II clinical study of PD-1 monoclonal antibody combined with radiotherapy in the treatment of recurrent or metastatic adrenal cortical carcinoma (ChiCTR2400089134)
    P2, N=36, Not yet recruiting, Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center
    New P2 trial • Metastases
    |
    Loqtorzi (toripalimab-tpzi)
    8d
    A basket study of Initumab combined with pyrrotinib and triplizumab in the treatment of HER2 variant advanced solid tumors (ChiCTR2400089182)
    P2, N=193, Not yet recruiting, Shanghai East Hospital; Shanghai East Hospital
    New P2 trial • Pan tumor • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification • HER-2 mutation
    |
    Loqtorzi (toripalimab-tpzi)
    8d
    GP combined with Toripalimab Versus GP Induction Chemotherapy for Advanced childhood Nasopharyngeal Carcinoma (ChiCTR2400089865)
    P2, N=72, Recruiting, Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center
    New P2 trial • Combination therapy • Metastases
    |
    cisplatin • gemcitabine • Loqtorzi (toripalimab-tpzi)
    8d
    A Prospective, Open Phase II Clinical Study Evaluating the Safety and Efficacy of chidamide in Combination with Toripalimab and Anlotinib for the Second-Line Treatment of Advanced or Unresectable Soft Tissue Sarcomas (ChiCTR2400090218)
    P2, N=42, Recruiting, Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center
    New P2 trial • Combination therapy • Metastases
    |
    Focus V (anlotinib) • Loqtorzi (toripalimab-tpzi) • Epidaza (chidamide)
    10d
    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, Not yet recruiting, Coherus Biosciences, Inc.
    New P2 trial • Combination therapy • Metastases
    |
    Avastin (bevacizumab) • Loqtorzi (toripalimab-tpzi) • casdozokitug (CHS-388)
    13d
    TRANSPARENT: A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer (clinicaltrials.gov)
    P4, N=100, Recruiting, Coherus Biosciences, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    cisplatin • carboplatin • gemcitabine • Loqtorzi (toripalimab-tpzi)
    14d
    NEOTRIO-HR: Neoadjuvant Toripalimab and Radiotherapy Treatment in N+ HR+ Breast Cancer (clinicaltrials.gov)
    P2, N=74, Not yet recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University
    New P2 trial
    |
    paclitaxel • Loqtorzi (toripalimab-tpzi) • cyclophosphamide • epirubicin
    17d
    Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1, N=56, Recruiting, Ruijin Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Loqtorzi (toripalimab-tpzi)
    18d
    CAN1012 Combined With PD-1 in Patients With Solid Tumors (clinicaltrials.gov)
    P1/2, N=71, Recruiting, Canwell Biotech Limited | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Loqtorzi (toripalimab-tpzi)
    18d
    Phase I Study of WJ47156 Monotherarpy and in Combination With Other Therapy in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=93, Recruiting, Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Avastin (bevacizumab) • Loqtorzi (toripalimab-tpzi)
    19d
    Conversion therapy in advanced perihilar cholangiocarcinoma based on patient-derived organoids: A case report. (PubMed, World J Gastrointest Oncol)
    PDOs for drug sensitivity contribute to screening effective chemotherapy drugs for advanced pCCA, promoting conversion therapy and improving the prognosis.
    Journal • Metastases
    |
    CEACAM5 (CEA Cell Adhesion Molecule 5) • AFP (Alpha-fetoprotein)
    |
    cisplatin • gemcitabine • Lenvima (lenvatinib) • Loqtorzi (toripalimab-tpzi) • albumin-bound paclitaxel
    21d
    GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma (clinicaltrials.gov)
    P=N/A, N=80, Recruiting, Tianjin Medical University Cancer Institute and Hospital | N=120 --> 80 | Trial primary completion date: Jan 2024 --> May 2024
    Enrollment change • Trial primary completion date • IO biomarker • Metastases
    |
    Lenvima (lenvatinib) • Loqtorzi (toripalimab-tpzi) • oxaliplatin
    25d
    A Study of CHS-114 in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=40, Not yet recruiting, Coherus Biosciences, Inc.
    New P1 trial
    |
    Loqtorzi (toripalimab-tpzi) • CHS-114
    26d
    SBRT Followed by Chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin for Larynx Preservation in Patients with Locally Regionally Advanced Squamous Cell Carcinoma of the Larynx and Hypopharynx (clinicaltrials.gov)
    P2, N=35, Recruiting, Sun Yat-sen University | Phase classification: P1 --> P2 | N=25 --> 35
    Phase classification • Enrollment change • Metastases
    |
    cisplatin • docetaxel • Loqtorzi (toripalimab-tpzi)
    26d
    A Single-arm, Open-label, Prospective Clinical Study of Surufatinib Combined With Immunotherapy and Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer. (clinicaltrials.gov)
    P2, N=23, Not yet recruiting, Fujian Cancer Hospital
    New P2 trial • Metastases
    |
    Loqtorzi (toripalimab-tpzi) • oxaliplatin • Sulanda (surufatinib)
    1m
    Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, Shanghai Pulmonary Hospital, Shanghai, China
    New P2 trial
    |
    Loqtorzi (toripalimab-tpzi) • etoposide IV • tifcemalimab (TAB004)
    1m
    Neoadjuvant Toripalimab + Chemotherapy ± Cetuximab in Locally Advanced Head and Neck Squamous Cell Carcinoma (Neo-ICT) (clinicaltrials.gov)
    P3, N=355, Not yet recruiting, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
    New P3 trial • Metastases
    |
    Erbitux (cetuximab) • cisplatin • carboplatin • Loqtorzi (toripalimab-tpzi) • albumin-bound paclitaxel
    1m
    Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, RemeGen Co., Ltd.
    New P2 trial • Combination therapy • Metastases
    |
    Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin)
    1m
    Study of LM-108 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours (clinicaltrials.gov)
    P1/2, N=392, Enrolling by invitation, LaNova Medicines Limited | Recruiting --> Enrolling by invitation
    Enrollment status • Combination therapy • Metastases
    |
    Loqtorzi (toripalimab-tpzi) • LM-108
    1m
    Toripalimab Combined with Cryoablation for First-line Oligo-progression in Driver-negative Advanced NSCLC (clinicaltrials.gov)
    P2, N=54, Recruiting, Shanghai Chest Hospital | Not yet recruiting --> Recruiting | Trial completion date: Nov 2026 --> Apr 2028 | Initiation date: Nov 2023 --> Apr 2024 | Trial primary completion date: Nov 2025 --> Apr 2026
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    Loqtorzi (toripalimab-tpzi)
    1m
    All Trans Retinoic Acid Combined with Toripalimab+Chemotherapy for Locally Advanced Inoperable or Metastatic Triple Negative Breast Cancer：a Multi-center, Multi-cohort Phase II Trial (clinicaltrials.gov)
    P2, N=129, Not yet recruiting, Fudan University
    New P2 trial • Metastases
    |
    Loqtorzi (toripalimab-tpzi) • capecitabine • albumin-bound paclitaxel
    1m
    Toripalimab in combination with chemotherapy effectively suppresses local recurrence and metastatic sarcomatoid renal cell carcinoma: A case report. (PubMed, World J Clin Cases)
    Combination therapy with programmed death 1 antibodies and cytotoxic agents may be a recommended first-line treatment approach for SRCC.
    Journal • Combination therapy • Metastases
    |
    CA9 (Carbonic anhydrase 9)
    |
    Loqtorzi (toripalimab-tpzi) • Pinorubin (pirarubicin)
    1m
    Toripalimab in combination with HBM4003, an anti-CTLA-4 heavy chain-only antibody, in advanced melanoma and other solid tumors: an open-label phase I trial. (PubMed, J Immunother Cancer)
    HBM4003 0.3 mg/kg plus toripalimab 240 mg every 3 week demonstrated manageable safety in solid tumors and no new safety signal. Limited data demonstrated promising antitumor activity, especially in PD-1 treatment-naïve mucosal melanoma.
    P1 data • Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    CD4 (CD4 Molecule)
    |
    Loqtorzi (toripalimab-tpzi) • porustobart (HBM4003)
    2ms
    Neoadjuvant toripalimab plus axitinib for clear cell renal cell carcinoma with inferior vena cava tumor thrombus: NEOTAX, a phase 2 study. (PubMed, Signal Transduct Target Ther)
    In surgical samples of the TT, non-responders exhibited increased CD8T_01_GZMK_CXCR4 subset T cells. NEOTAX met preset endpoints proving that toripalimab in combination with axitinib downstages IVC-TT in a significant proportion of patients leading to simplification in the procedure of surgery.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-1 (Programmed cell death 1)
    |
    PD-1 positive
    |
    Loqtorzi (toripalimab-tpzi) • Inlyta (axitinib)
    2ms
    Effectiveness, safety, and biomarker analysis of lenvatinib plus toripalimab as chemo-free therapy in advanced intrahepatic cholangiocarcinoma: a real-world study. (PubMed, Cancer Immunol Immunother)
    Lenvatinib plus toripalimab represents an effective and well-tolerated chemo-free therapeutic option for advanced ICC. Baseline CA19-9 levels and IDH1 mutations may serve as predictive treatment-related biomarkers.
    Retrospective data • Journal • Real-world evidence • PD(L)-1 Biomarker • IO biomarker • Real-world • Metastases
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • CA 19-9 (Cancer antigen 19-9)
    |
    IDH1 mutation
    |
    Lenvima (lenvatinib) • Loqtorzi (toripalimab-tpzi)
    2ms
    Toripalimab combined with definitive chemoradiotherapy for locally advanced cervical squamous cell carcinoma patients (TRACE): A single-arm, phase I/II trial. (PubMed, Cancer Immunol Immunother)
    Toripalimab combined with CCRT achieved good tolerance and showed promising anti-tumor effects in patients with locally advanced cervical cancer.
    P1/2 data • Journal • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    cisplatin • Loqtorzi (toripalimab-tpzi)
    2ms
    A Study of ES102 in Combination With Toripalimab in Subjects With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Elpiscience (Suzhou) Biopharma, Ltd.
    New P2 trial
    |
    Loqtorzi (toripalimab-tpzi) • INBRX-106
    2ms
    Neoadjuvant Toripalimab Plus Liposomal Paclitaxel and Carboplatin in Patients With Localized TNBC (NeoTOP) (clinicaltrials.gov)
    P2, N=46, Recruiting, Sun Yat-sen University
    New P2 trial
    |
    carboplatin • paclitaxel • Loqtorzi (toripalimab-tpzi)
    2ms
    A new treatment approach of toripalimab in combination with concurrent platinum-based chemoradiotherapy for locally advanced cervical cancer: A phase II clinical trial. (PubMed, Int J Cancer)
    A total of 37 patients experienced treatment-related adverse events, of which 17 (20.7%) patients experienced grade 3 or higher adverse events. Collectively, toripalimab plus concurrent platinum-based chemoradiotherapy showed promising antitumor efficacy with acceptable safety profiles in patients with untreated locally advanced cervical cancer.
    P2 data • Journal • Combination therapy • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden)
    |
    PD-L1 expression • TMB-L
    |
    Loqtorzi (toripalimab-tpzi)
    2ms
    Immunotherapy Rechallenge in Patients with Solid Tumors in Clinical Trials (clinicaltrials.gov)
    P1/2, N=100, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New P1/2 trial • Metastases
    |
    Loqtorzi (toripalimab-tpzi)
    2ms
    Adjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer (NEOTORCH-BREAST01) (clinicaltrials.gov)
    P2, N=50, Recruiting, First Affiliated Hospital of Zhejiang University
    New P2 trial • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    paclitaxel • Loqtorzi (toripalimab-tpzi) • cyclophosphamide • epirubicin
    2ms
    ZYYY-IIT-TNBC-001: A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC. (clinicaltrials.gov)
    P=N/A, N=32, Not yet recruiting, First Affiliated Hospital of Zhejiang University | Initiation date: May 2024 --> Oct 2024
    Trial initiation date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Loqtorzi (toripalimab-tpzi)
    2ms
    SBRT Followed by Chemoimmunotherapy of Toripalimab Plus Docetaxel and Cisplatin for Larynx Preservation in Patients with Locally Regionally Advanced Squamous Cell Carcinoma of the Larynx and Hypopharynx (clinicaltrials.gov)
    P1, N=25, Recruiting, Sun Yat-sen University
    New P1 trial • New P2 trial • Metastases
    |
    cisplatin • docetaxel • Loqtorzi (toripalimab-tpzi)
    2ms
    A Study to Assess LBL-007 in Combination With Toripalimab and Axitinib Tablets Subjects With Advanced Melanoma (clinicaltrials.gov)
    P1, N=88, Recruiting, Nanjing Leads Biolabs Co.,Ltd | Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Aug 2024 --> Mar 2025
    Trial completion date • Trial primary completion date
    |
    Loqtorzi (toripalimab-tpzi) • Inlyta (axitinib) • LBL-007
    2ms
    MELATORCH: A Randomized, Controlled, Multi-center, Phase III Clinical Study to Investigate Recombinant Humanized PD-1 Monoclonal Antibody Injection (JS001) Versus Dacarbazine as the 1st-line Therapy for Unresectable or Metastatic Melanoma (clinicaltrials.gov)
    P3, N=256, Completed, Shanghai Junshi Bioscience Co., Ltd. | Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Nov 2023
    Trial completion • Trial completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Loqtorzi (toripalimab-tpzi) • dacarbazine
    2ms
    A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients (clinicaltrials.gov)
    P2, N=24, Recruiting, Georgetown University | Suspended --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    Loqtorzi (toripalimab-tpzi)