Toripalimab

Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors.

• LOQTORZI is a programmed death receptor-1 (PD-1)- blocking antibody indicated: in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) ( 1.1 ) as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy ( 1.2 ) 1.1 First-line Treatment of Metastatic or Recurrent, Locally Advanced NPC with Cisplatin and Gemcitabine LOQTORZI is indicated, in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or with recurrent, locally advanced nasopharyngeal carcinoma (NPC). 1.2 Previously Treated Unresectable or Metastatic NPC LOQTORZI is indicated, as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.

• None .contraindicated

In combination with cisplatin and gemcitabine: 240 mg intravenously every three weeks ( 2.1 ) As a single agent: 3 mg/kg intravenously every two weeks ( 2.1 ) First Infusion : Infuse over 60 minutes. Subsequent Infusions : If no infusion-related reactions occurred during the first infusion, subsequent infusions may be administered over 30 minutes. 2.1 Recommended Dosage The recommended dosages of LOQTORZI are provided in Table 1. Administer as recommended [see Dosage and Administration (2.3) ]. Table 1: Recommended Dosage Indication Recommended Dosage of LOQTORZI Duration of Treatment First-line NPC 240 mg every three weeks Until disease progression, unacceptable toxicity, or up to 24 months. Recurrent NPC 3 mg/kg every two weeks Until disease progression or unacceptable toxicity. 2.2 Dosage Modifications No dose reductions of LOQTORZI are recommended. In general, withhold LOQTORZI for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue LOQTORZI for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce prednisone to 10 mg per day or less (or equivalent) within 12 weeks of initiating steroids. Dosage modifications for LOQTORZI for adverse reactions that require management different from these general guidelines are summarized in Table 2.

Immune-Mediated Adverse Reactions ( 5.1 ) Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic adverse reactions, and solid organ transplant rejection. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. ( 5.1 ) Withhold or permanently discontinue based on severity and type of reaction. ( 5.1 ) Infusion-related reactions : Interrupt, slow the rate of infusion, or permanently discontinue LOQTORZI based on the severity of reaction. ( 5.2 ) Complications of allogeneic HSCT : Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody. ( 5.3 ) Embryo-fetal toxicity : Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective method of contraception. ( 5.4 , 8.1 , 8.3 ) 5.1 Severe and Fatal Immune-Mediated Adverse Reactions LOQTORZI is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions.

The following clinically significant adverse reactions are described elsewhere in the labeling: Severe and fatal immune-mediated adverse reactions [see Warnings and Precautions (5.1) ] Infusion-related reactions [see Warnings and Precautions (5.2) ] Complications of Allogeneic HSCT [see Warnings and Precautions (5.3) ] LOQTORZI in Combination with Cisplatin and Gemcitabine The most common adverse reactions (≥ 20%) are nausea, vomiting, decreased appetite, constipation, hypothyroidism, rash, pyrexia, diarrhea, peripheral neuropathy, cough, musculoskeletal pain, upper respiratory infection, insomnia, dizziness, and malaise. ( 6.1 ) LOQTORZI as a Single Agent The most common adverse reactions (≥ 20%) are fatigue, hypothyroidism and musculoskeletal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Coherus Oncology, Inc. at 1-800-483-3692 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described in the WARNINGS AND PRECAUTIONS section reflect exposure to LOQTORZI at a dose of 240 mg every 3 weeks in combination with up to 6 cycles of cisplatin and gemcitabine, followed by LOQTORZI 240 mg IV every 3 weeks, in 146 patients with NPC enrolled in a randomized, double-blind, placebo-controlled trial (JUPITER-02).

Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on its mechanism of action, LOQTORZI can cause fetal harm when administered to a pregnant woman [ see Clinical Pharmacology (12.1) ] . There are no available data on the use of LOQTORZI in pregnant women. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus and result in fetal death (see Data ) . Human IgG4 immunoglobulins (IgG4) are known to cross the placenta; therefore, LOQTORZI can potentially be transmitted from the mother to the developing fetus. Advise women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Animal reproduction studies have not been conducted with LOQTORZI to evaluate its effect on reproduction and fetal development. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus.

Metabolism

Toripalimab-tpzi pharmacokinetic parameters are presented as geometric mean (coefficient of variation [CV]%) unless otherwise noted. Toripalimab-tpzi concentrations increased in non-linearly over the dose range of 0.3 to 10 mg/kg every two weeks (0.1 to 3.3 times the approved recommended 3 mg/kg dosage in a 64 kg patient).

• Oct 27, 2023BLABLA761240Coherus Biosciences Inc

1. 1Death440%
2. 2Hospitalisation220%
3. 3Off Label Use220%
4. 4Blood Calcium Abnormal110%
5. 5Breast Cancer Metastatic110%
6. 6Hepatitis110%
7. 7Hospice Care110%
8. 8Hypersensitivity110%
9. 9Hypertension110%
10. 10Lethargy110%
11. 11Musculoskeletal Pain110%
12. 12Neutrophil Count Decreased110%
13. 13Product Use In Unapproved Indication110%
14. 14Sepsis110%
15. 15Weight Decreased110%

The 10 most recently updated of 657 ClinicalTrials.gov registrations naming Toripalimab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma
  Recruiting · Phase 2 · Interventional · 55 enrolled · Sun Yat-sen University
  NCT07644897updated 2026-06-12
• A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors
  Recruiting · Phase 1 · Interventional · 154 enrolled · Coherus Oncology, Inc.
  NCT06657144updated 2026-06-12
• Toripalimab Combined With Platinum-based Chemotherapy With or Without H1 Receptor Antagonist in the Perioperative Treatment of Resectable Non-small Cell Lung Cancer
  Not yet recruiting · Phase 2 · Interventional · 120 enrolled · Tianjin Medical University Cancer Institute and Hospital
  NCT07358689updated 2026-06-12
• Exploratory Study on Toripalimab and Anlotinib Combined With Standard Chemotherapy for Refractory Dermatofibrosarcoma Protuberans
  Not yet recruiting · Phase 2 · Interventional · 20 enrolled · Yanjie Zhang, MD
  NCT07646080updated 2026-06-12
• Toripalimab Combined With CAV/IE Regimen
  Recruiting · Phase 2 · Interventional · 134 enrolled · Sun Yat-sen University
  NCT04589741updated 2026-06-12
• Chidamide Combined With Toripalimab in Sarcoma
  Completed · Phase 2 · Interventional · 73 enrolled · Sun Yat-sen University
  NCT04025931updated 2026-06-12
• Anlotinib Combined With Toripalimab in Refractory and Advanced Soft-tissue Sarcoma
  Completed · Phase 2 · Interventional · 70 enrolled · Sun Yat-sen University
  NCT04172805updated 2026-06-11
• The Application of Locoregional Therapy Combined With Systemic Therapy in the Perioperative Period of Huge Hepatocellular Carcinoma: A Retrospective Cohort Study
  Completed · Observational · 715 enrolled · Tongji Hospital
  NCT07639294updated 2026-06-10
• Surgery vs. Radical Chemoradiotherapy for Esophageal SCC After Neoadjuvant Immunochemotherapy
  Not yet recruiting · Phase 3 · Interventional · 1,044 enrolled · Henan Cancer Hospital
  NCT07629817updated 2026-06-10
• PTC-Guided Atorvastatin Plus Axitinib and Toripalimab in Advanced RCC
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 40 enrolled · Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  NCT07630363updated 2026-06-05

Frequently asked questions

How does Toripalimab work?

Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors.

What is Toripalimab used for?

According to FDA labeling, Toripalimab carries indications including: LOQTORZI is a programmed death receptor-1 (PD-1)- blocking antibody indicated: in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) ( 1.1 ) as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy ( 1.2 ) 1.1 First-line Treatment of Metastatic or Recurrent, Locally Advanced NPC with Cisplatin and Gemcitabine LOQTORZI is indicated, in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or with recurrent, locally advanced nasopharyngeal carcinoma (NPC). 1.2 Previously Treated Unresectable or Metastatic NPC LOQTORZI is indicated, as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Toripalimab?

Toripalimab is classified as PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors, Programmed Death Receptor-1 Blocking Antibody, Antibody-Receptor Interactions, Programmed Death Receptor-1-directed Antibody Interactions, Decreased Cytokine Production, Increased Immunologic Activity.

What are the brand names for Toripalimab?

Toripalimab is marketed under brand names including Loqtorzi.

What are the contraindications for Toripalimab?

Toripalimab labeling lists contraindications including: None .. Always consult the full prescribing information and a clinician.