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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:
    13h
    Role of PD-1/PD-L1 signaling axis in oncogenesis and its targeting by bioactive natural compounds for cancer immunotherapy. (PubMed, Mil Med Res)
    A range of monoclonal antibodies, including avelumab, atezolizumab, camrelizumab, dostarlimab, durvalumab, sinitilimab, toripalimab, and zimberelimab, have been developed for targeting the interaction between PD-1 and PD-L1. Moreover, the primary focus will be on the underlying mechanism of action as well as the clinical efficacy of bioactive molecules. Current challenges along with the scope of future research directions targeting PD-1/PD-L1 interactions through natural substances are also discussed.
    Review • Journal
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • Loqtorzi (toripalimab-tpzi) • AiRuiKa (camrelizumab) • Jemperli (dostarlimab-gxly) • Yutuo (zimberelimab)
    3d
    The Optimal Radioimmunotherapy Combinations for Advanced TNBC (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Sun Yat-sen University
    New P2 trial • Metastases
    |
    carboplatin • Loqtorzi (toripalimab-tpzi) • albumin-bound paclitaxel
    5d
    Radiolabelled anti-PD-L1 peptide PET/CT in predicting the efficacy of neoadjuvant immunotherapy combined with chemotherapy in resectable non-small cell lung cancer. (PubMed, Ann Nucl Med)
    Baseline 68Ga-NOTA-WL12 PET/CT has a potential to predict the pathological response of neoadjuvant immunotherapy combined with chemotherapy in patients with resectable NSCLC, whose efficacy is comparable to that of therapy evaluations employing baseline and follow-up CT and 18F-FDG PET/CT examinations.
    Journal
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    PD-L1 (Programmed death ligand 1)
    |
    cisplatin • Loqtorzi (toripalimab-tpzi) • albumin-bound paclitaxel • toripalimab subcutaneous (JS001sc)
    5d
    A Trial of GFH018 and Toripalimab in Combination with Concurrent Chemoradiotherapy in Stage III NSCLC Chemoradiotherapy in Stage III NSCLC (clinicaltrials.gov)
    P2, N=65, Active, not recruiting, Genfleet Therapeutics (Shanghai) Inc. | Trial completion date: Jan 2025 --> Jul 2025 | Trial primary completion date: Oct 2024 --> May 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    cisplatin • carboplatin • paclitaxel • Loqtorzi (toripalimab-tpzi) • pemetrexed • GFH018
    6d
    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, Recruiting, Fudan University | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Loqtorzi (toripalimab-tpzi) • capecitabine • albumin-bound paclitaxel
    6d
    Low-dose Radiotherapy Combined with Concurrent Chemotherapy, Toripalimab and Tifcemalimab in the Treatment of ES-SCLC (clinicaltrials.gov)
    P1, N=12, Not yet recruiting, Sichuan University
    New P1 trial
    |
    cisplatin • carboplatin • Loqtorzi (toripalimab-tpzi) • etoposide IV • tifcemalimab (TAB004)
    7d
    A Prospective，Single Arm, Multicenter Clinical Study of BTLA Monoclonal Antibody JS004 (B/T Lymphocyte Attenuator Factor Monoclonal Antibody) in Combination With Toripalimab in Patients With Unresectable or Advanced Renal Cell Carcinoma Who Had Failed Previous Immunotherapy (clinicaltrials.gov)
    P2, N=31, Not yet recruiting, RenJi Hospital
    New P2 trial • Combination therapy • Metastases
    |
    Loqtorzi (toripalimab-tpzi) • tifcemalimab (TAB004)
    7d
    Toripalimab and Anlotinib Combination Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma After Failure of at Least One Line of Platinum-Based Chemotherapy (TORAL) (clinicaltrials.gov)
    P2, N=40, Completed, Sun Yat-sen University | Active, not recruiting --> Completed | Trial completion date: Oct 2026 --> Dec 2024
    Trial completion • Trial completion date • Metastases
    |
    Focus V (anlotinib) • Loqtorzi (toripalimab-tpzi)
    8d
    GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma (clinicaltrials.gov)
    P=N/A, N=146, Recruiting, Tianjin Medical University Cancer Institute and Hospital | N=80 --> 146
    Enrollment change • IO biomarker • Metastases
    |
    Lenvima (lenvatinib) • Loqtorzi (toripalimab-tpzi) • oxaliplatin
    9d
    A Study of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations (clinicaltrials.gov)
    P2, N=20, Recruiting, Shanghai Jiatan Pharmatech Co., Ltd | Trial completion date: Dec 2025 --> Dec 2026
    Trial completion date • Metastases
    |
    Loqtorzi (toripalimab-tpzi)
    9d
    Neoadjuvant Toripalimab Plus Docetaxel and Carboplatin in Patients With Localized TNBC (NeoTOP) (clinicaltrials.gov)
    P2, N=50, Recruiting, Sun Yat-sen University | Initiation date: Nov 2022 --> Jan 2022
    Trial initiation date
    |
    carboplatin • docetaxel • Loqtorzi (toripalimab-tpzi)
    12d
    CONTINUE: ctDNA-MRD Guided Consolidation Toripalimab in Stage IB-IIIA NSCLC (clinicaltrials.gov)
    P2, N=80, Recruiting, Sun Yat-sen University | Not yet recruiting --> Recruiting | Trial completion date: Jul 2029 --> Dec 2029 | Trial primary completion date: Jul 2026 --> Dec 2026
    Enrollment open • Trial completion date • Trial primary completion date • Minimal residual disease • Circulating tumor DNA
    |
    Loqtorzi (toripalimab-tpzi)
    12d
    Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=47, Recruiting, Sun Yat-sen University
    New P2 trial
    |
    cisplatin • carboplatin • Loqtorzi (toripalimab-tpzi) • Sulanda (surufatinib)
    13d
    NASCR: Neoadjuvant JS001, or JS001 in Combination With Pemetrexed and Carboplatin in Resectable NSCLC. (clinicaltrials.gov)
    P2, N=0, Withdrawn, Sun Yat-sen University | N=80 --> 0 | Suspended --> Withdrawn
    Enrollment change • Trial withdrawal • Combination therapy
    |
    carboplatin • Loqtorzi (toripalimab-tpzi) • pemetrexed
    13d
    Toripalimab Combined With Gemcitabine and Cisplatin (GemCis) as Preoperative Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma (clinicaltrials.gov)
    P2, N=70, Recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial
    |
    cisplatin • gemcitabine • Loqtorzi (toripalimab-tpzi)
    13d
    Toripalimab Combined With Capecitabine as Postoperative Adjuvant Therapy for Patients With Resectable Advanced Extrahepatic Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=110, Active, not recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial • Metastases
    |
    Loqtorzi (toripalimab-tpzi) • capecitabine
    15d
    GZZJU-2021NB: Neoadjuvant Toripalimab in Combination with Gemcitabine and Cisplatin Therapy in Local Advanced Bladder Cancer Subjects (clinicaltrials.gov)
    P2, N=41, Recruiting, Zhujiang Hospital | Trial completion date: Apr 2025 --> Apr 2027 | Trial primary completion date: Oct 2023 --> Oct 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    cisplatin • gemcitabine • Loqtorzi (toripalimab-tpzi)
    16d
    PD-1 Blockade Combined with Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced SCCA Patients (clinicaltrials.gov)
    P2, N=25, Completed, Sun Yat-sen University | Enrolling by invitation --> Completed | Trial completion date: Jun 2024 --> Nov 2024
    Trial completion • Trial completion date • Metastases
    |
    CD4 (CD4 Molecule)
    |
    cisplatin • Loqtorzi (toripalimab-tpzi)
    16d
    Deep learning-assisted colonoscopy images for prediction of mismatch repair deficiency in colorectal cancer. (PubMed, Surg Endosc)
    The model achieved a high NPV in detecting deficient mismatch repair colorectal cancers. This model might serve as an automatic screening tool.
    Journal • Mismatch repair • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Loqtorzi (toripalimab-tpzi) • celecoxib oral
    17d
    Navigation: Toripalimab vs. Placebo Wtih GP Induction Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma (clinicaltrials.gov)
    P3, N=466, Not yet recruiting, Sun Yat-sen University
    New P3 trial • IO biomarker • Metastases
    |
    cisplatin • Loqtorzi (toripalimab-tpzi)
    17d
    Toripalimab plus anlotinib in patients with recurrent or metastatic nasopharyngeal carcinoma: A multicenter, single-arm phase 2 trial (TORAL). (PubMed, Cell Rep Med)
    In conclusion, toripalimab plus anlotinib is well tolerated and shows promising efficacy in patients with RM-NPC, and ctDNA could be a potential predictive biomarker. The trial is registered at ClinicalTrials.gov (NCT04996758).
    P2 data • Journal • Tumor mutational burden • Metastases
    |
    TMB (Tumor Mutational Burden)
    |
    Focus V (anlotinib) • Loqtorzi (toripalimab-tpzi)
    20d
    MOTION-NSCLC: Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC (clinicaltrials.gov)
    P=N/A, N=342, Not yet recruiting, Guangdong Association of Clinical Trials
    New trial • Minimal residual disease
    |
    Tagrisso (osimertinib) • Alecensa (alectinib) • Loqtorzi (toripalimab-tpzi)
    23d
    Radiotherapy Followed by Chemotherapy Combined With Toripalimab in Local Advanced HR-positive,HER2-negative BC. (clinicaltrials.gov)
    P2, N=30, Recruiting, First Affiliated Hospital of Zhejiang University
    New P2 trial • Metastases
    |
    Loqtorzi (toripalimab-tpzi) • albumin-bound paclitaxel • cyclophosphamide • epirubicin
    24d
    JYP0390M203: A Study of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=100, Recruiting, Shanghai Jiatan Pharmatech Co., Ltd | Trial completion date: Mar 2025 --> Nov 2025 | Trial primary completion date: Mar 2025 --> Nov 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    Loqtorzi (toripalimab-tpzi)
    24d
    Spatial interactions of immune cells as potential predictors to efficacy of toripalimab plus chemotherapy in locally advanced or metastatic pancreatic ductal adenocarcinoma: a phase Ib/II trial. (PubMed, Signal Transduct Target Ther)
    This phase Ib/II study evaluated the safety and efficacy of combining toripalimab with the gemcitabine plus nab-paclitaxel (GnP) regimen as first-line treatment for locally advanced or metastatic PDAC and explored predictive biomarkers (ChiCTR2000032293). Importantly, dendritic cells - T helper cells - cytotoxic T lymphocytes (DC-Th-CTL) enriched immune niche and their spatial interactions were dominant predictors of response based on TIME analysis using a cyclic multiplex tissue staining assay, with an area under the curve value of 0.8. Overall, GnP plus toripalimab exhibited good safety and differentiated efficacy in selected population, and the spatial interactions of DC-Th-CTL represent promising predictors to efficacy of immunochemotherapy in locally advanced or metastatic PDAC.
    P1/2 data • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases • Immune cell
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    gemcitabine • Loqtorzi (toripalimab-tpzi) • albumin-bound paclitaxel
    27d
    Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies (clinicaltrials.gov)
    P1, N=184, Completed, TopAlliance Biosciences | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Loqtorzi (toripalimab-tpzi)
    1m
    TOPLINE: Neoadjuvant Toripalimab for Clinically Stage II-IIIB Resectable Non-small Cell Lung Cancer with EGFR Mutation and PD-L1 Positive Expression (clinicaltrials.gov)
    P2, N=29, Recruiting, Ruijin Hospital | Not yet recruiting --> Recruiting
    Enrollment open • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    Loqtorzi (toripalimab-tpzi)
    1m
    SPRING: Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS (clinicaltrials.gov)
    P2, N=200, Not yet recruiting, Peking University Shenzhen Hospital
    New P2 trial
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • cisplatin • Tagrisso (osimertinib) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • Zelboraf (vemurafenib) • Imfinzi (durvalumab) • gemcitabine • Rozlytrek (entrectinib) • imatinib • 5-fluorouracil • Tyvyt (sintilimab) • Alecensa (alectinib) • Nerlynx (neratinib) • Loqtorzi (toripalimab-tpzi) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr) • Irene (pyrotinib) • Balversa (erdafitinib) • albumin-bound paclitaxel • irinotecan • Orpathys (savolitinib) • epirubicin • vinorelbine tartrate • Partruvix (pamiparib) • Epkinly (epcoritamab-bysp) • Hetronifly (serplulimab) • Enweida (envafolimab) • Vumon (teniposide) • Ariely (adebrelimab)
    1m
    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
    1m
    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)
    1m
    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
    1m
    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
    1m
    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)
    1m
    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)
    1m
    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)
    1m
    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)
    1m
    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)
    1m
    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)
    1m
    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)
    1m
    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)
    1m
    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
    2ms
    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)