# Toripalimab

Source: https://onco.cc/drugs/toripalimab/  
OnCo record `toripalimab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A Chinese-developed PD-1 blocker that became the first immunotherapy approved in the US for nasopharyngeal cancer.

## Summary

Approved by the FDA 27 October 2023 with gemcitabine-cisplatin for first-line recurrent or metastatic NPC and as monotherapy after platinum (JUPITER-02, POLARIS-02); EU approval 2024 for NPC and oesophageal squamous cell carcinoma. Broadly approved in China across lung, oesophageal, urothelial, and other cancers. Junshi Biosciences; Coherus in the US.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Loqtorzi
- Modality: Monoclonal antibody (anti-PD-1)
- Mechanism: Humanised IgG4 anti-PD-1 with a distinct epitope and slow off-rate.
- Approvals: US 2023: Recurrent/metastatic nasopharyngeal carcinoma, first line with chemotherapy and later lines; China 2018: Melanoma (first of many indications)
- Dosing: Intravenous; 240 mg every 3 weeks with gemcitabine-cisplatin for up to 6 cycles, then maintenance

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Toripalimab
- FDA approval coverage: https://www.onclive.com/view/fda-approves-toripalimab-for-recurrent-or-metastatic-nasopharyngeal-carcinoma

## Connected records

- cancers: [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/), [Locoregionally advanced nasopharyngeal carcinoma (stage III to IVA)](https://onco.cc/cancers/locoregionally-advanced-nasopharyngeal-carcinoma/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Mucosal melanoma](https://onco.cc/cancers/mucosal-melanoma/), [Nasopharyngeal carcinoma](https://onco.cc/cancers/nasopharyngeal/), [Oesophageal cancer](https://onco.cc/cancers/esophageal/), [Recurrent and metastatic nasopharyngeal carcinoma](https://onco.cc/cancers/recurrent-metastatic-nasopharyngeal-carcinoma/), [Resectable stage I to III non-small-cell lung cancer](https://onco.cc/cancers/resectable-nsclc/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [BTLA](https://onco.cc/targets/btla/), [PD-1](https://onco.cc/targets/pd1/)
- companies: [Coherus BioSciences](https://onco.cc/companies/coherus/), [Shanghai Jiatan Pharmatech](https://onco.cc/companies/shanghai-jiatan-pharmatech/), [Shanghai Junshi Biosciences](https://onco.cc/companies/junshi/)
- terms: [Immune-related adverse events (irAEs)](https://onco.cc/terms/irae/)
- trials: [9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma](https://onco.cc/trials/nct06823427/), [9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer](https://onco.cc/trials/nct07314723/), [9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer](https://onco.cc/trials/nct06079112/), [9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer](https://onco.cc/trials/nct06592326/), [A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors](https://onco.cc/trials/nct06208410/), [A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer](https://onco.cc/trials/nct07111832/), [A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study](https://onco.cc/trials/nct05934331/), [A Multicenter, Prospective, Cohort Study of Trop-2 ADC Combination Therapy for Advanced Triple-negative Breast Cancer](https://onco.cc/trials/nct06878625/), [A Multicenter, Randomized Controlled Phase II Study of Short-Course Radiotherapy Followed by Sequential PD-1 Inhibitor and FOLFOX Chemotherapy Versus Long-Cours](https://onco.cc/trials/nct07669220/), [A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors](https://onco.cc/trials/nct05615974/), [A Phase I/II Study of LM-2417 in Subjects With Advanced Solid Tumours](https://onco.cc/trials/nct06682780/), [A Phase I/II Study of WJB001 Combination Therapy on Safety and Efficacy for Advanced Solid Tumors](https://onco.cc/trials/nct06953323/), [A Phase I/IIa Study of AL8326 Combined With Toripalimab in the Treatment of Advanced Solid Tumors.](https://onco.cc/trials/nct07392736/), [A Phase Ib/II Clinical Study of Regorafenib Combined With Toripalimab and Albumin-bound Paclitaxel for the Third-line Treatment of Advanced Pancreatic Cancer](https://onco.cc/trials/nct07040228/), [A Randomized Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chemotherapy Alone as Neoadjuvant Therapy fo](https://onco.cc/trials/nct07101614/), [A Single-arm, Open-label, Prospective Clinical Study of Surufatinib Combined With Immunotherapy and Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer.](https://onco.cc/trials/nct06654947/), [A Study of DXC006 With Immune Checkpoint Inhibitors or Platinum for Small Cell Lung Cancer.](https://onco.cc/trials/nct07559929/), [A Study of ES102 in Combination With Toripalimab in Subjects With Advanced Non-small Cell Lung Cancer](https://onco.cc/trials/nct06623136/), [A Study of LM-108 as Monotherapy or in Combination With Antitumor Therapies in Subjects With Advanced Solid Tumors](https://onco.cc/trials/nct05518045/), [A Study of LM-168 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours](https://onco.cc/trials/nct06868199/), [A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC)](https://onco.cc/trials/nct06378177/), [A Study of RC118 Plus Toripalimab / RC148 in Patients with Locally Advanced Unresectable or Metastatic Solid Tumors](https://onco.cc/trials/nct06038396/), [A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer](https://onco.cc/trials/nct05980481/), [A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma](https://onco.cc/trials/nct05302284/), [A Study of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel in PD-L1 Positive Advanced TNBC](https://onco.cc/trials/nct07040644/), [A Study of SYS6010 Plus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy in Non-small Cell Lung Cancer (NSCLC)](https://onco.cc/trials/nct07672223/), [A Study of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors](https://onco.cc/trials/nct06117566/), [A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma.](https://onco.cc/trials/nct07258979/), [A Study of YL202 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors](https://onco.cc/trials/nct07169994/), [A Trial of Casdozokitug in Combination With Toripalimab Plus Bevacizumab in Participants With Unresectable and/or Locally Advanced or Metastatic Hepat](https://onco.cc/trials/nct06679985/), [A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer](https://onco.cc/trials/nct07281976/), [Adjuvant Toripalimab Plus Chemotherapy for EGFR/ALK Mutation Negative Stage II-IIIB(N2) NSCLC (LungMate-008)](https://onco.cc/trials/nct04772287/), [All Trans Retinoic Acid Combined with Toripalimab+Chemotherapy for Locally Advanced Inoperable or Metastatic Triple Negative Breast Cancer：a Multi-center, Multi](https://onco.cc/trials/nct06636981/), [APG-115 in Combination With PD-1 Inhibitor in Patients With Advanced Liposarcoma or Advanced Solid Tumors](https://onco.cc/trials/nct04785196/), [Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study](https://onco.cc/trials/nct06547203/), [Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC](https://onco.cc/trials/nct07281716/), [Consolidative Radiotherapy (CSRT) in Patients With Oligometastatic/Locally Advanced Unresectable Bilary Tract Cancer (BTC)](https://onco.cc/trials/nct06502080/), [Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer](https://onco.cc/trials/nct07159217/), [DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer](https://onco.cc/trials/nct06178159/), [Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer](https://onco.cc/trials/nct06642545/), [FMD and Neoadjuvant Chemo-immunotherapy in TNBC](https://onco.cc/trials/nct07378306/), [Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer](https://onco.cc/trials/nct07140679/), [IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors](https://onco.cc/trials/nct07508761/), [JS001sc or JS001 Plus Chemotherapy is Indicated for Relapsed or Metastatic First-Line Non-Squamous Non Small Cell Lung Cancer（NSCLC）](https://onco.cc/trials/nct06505837/), [JUPITER-02](https://onco.cc/trials/jupiter-02/), [JUPITER-06](https://onco.cc/trials/jupiter-06/), [KC1036 in Combination With PD-1 Antibody and Platinum-based Chemotherapy for First-line Advanced Esophageal Cancer](https://onco.cc/trials/nct07481058/), [LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer](https://onco.cc/trials/nct06387628/), [MR-guided Adaptive Radiotherapy Combined With PD-1 Antibody and CAPOX for Locally Advanced Rectal Cancer](https://onco.cc/trials/nct06840665/), [Neoadjuvant Chemotherapy Combined With Toripalimab for TNBC (NEOTORCH-BREAST02)](https://onco.cc/trials/nct06682195/), [Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases](https://onco.cc/trials/nct07277322/), [Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer](https://onco.cc/trials/nct06227117/), [Neoadjuvant Therapy of SBRT Sequencial With Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC Patients(neoR-TORCH)](https://onco.cc/trials/nct06437977/), [Neoadjuvant Toripalimab Plus SBRT for Chemo-Resistant Triple-Negative Breast Cancer](https://onco.cc/trials/nct07457359/), [Neoadjuvant Toripalimab With or Without Celecoxib in dMMR/MSI-H Colorectal Cancer](https://onco.cc/trials/nct03926338/), [Neotorch](https://onco.cc/trials/neotorch/), [Oncolytic Virus H101 Combined With Lenvatinib Plus Toripalimab Compared With FOLFOX in Patients With Advanced Biliary Tract Cancer (OPTIONS-06)](https://onco.cc/trials/nct06919848/), [Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma.](https://onco.cc/trials/nct06155383/), [Phase Ⅰ/Ⅱ Clinical Study to Evaluate ABO2011 in Advanced Solid Tumors](https://onco.cc/trials/nct06088004/), [Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer](https://onco.cc/trials/nct06852287/), [Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer](https://onco.cc/trials/nct05963490/), [Sac-TMT Combined With Toripalimab for First-line Treatment of PD-L1 Positive a/mTNBC](https://onco.cc/trials/nct07244874/), [Standard Systemic Therapy Combined With High/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer](https://onco.cc/trials/nct06525428/), [STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas](https://onco.cc/trials/nct06975293/), [Surufatinib Plus mFOLFIRINOX and PD-1 Inhibitor as the Neoadjuvant Therapy for High-risk or Borderline Resectable Pancreatic Cancer](https://onco.cc/trials/nct07469956/), [The Optimal Radioimmunotherapy Combinations for Advanced TNBC](https://onco.cc/trials/nct06735131/), [To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer](https://onco.cc/trials/nct06389006/), [Toripalimab Combined With Anthracycline-free or Anthracycline-containing Chemotherapy as Neoadjuvant Chemotherapy for Early Triple Negative Breast Cancer](https://onco.cc/trials/nct07256964/), [Toripalimab Combined With Capecitabine as Postoperative Adjuvant Therapy for Patients With Resectable Advanced Extrahepatic Biliary Tract Cancer](https://onco.cc/trials/nct06717464/), [Toripalimab Plus Anlotinib for the Maintenance of Extensive Stage Small Cell](https://onco.cc/trials/nct06441344/), [Toripalimab Plus Celecoxib for dMMR/MSI-H Locally Advanced Colorectal Cancer](https://onco.cc/trials/nct06903858/), [Toripalimab Plus Sacituzumab Tirumotecan as Neoadjuvant Therapy for Resectable NSCLC](https://onco.cc/trials/nct07819578/)
- people: [Jun Guo](https://onco.cc/people/guo-jun/), [Li Zhang](https://onco.cc/people/zhang-li-sysucc/), [Rui-Hua Xu](https://onco.cc/people/xu-rui-hua/)
- bottlenecks: [Incentives reward me-too drugs and marginal gains](https://onco.cc/bottlenecks/b-incentive-misalignment/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)
- collections: [CSCO guidelines (China)](https://onco.cc/collections/csco-guidelines/)
- key papers: [JUPITER-02: toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma](https://onco.cc/key-papers/paper-jupiter-02-toripalimab-chemotherapy-npc-nat-med-2021/)

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