# Tislelizumab

Source: https://onco.cc/drugs/tislelizumab/  
OnCo record `tislelizumab` (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, engineered to avoid a side-channel that may blunt other PD-1 drugs, now approved in the US and EU for oesophageal and stomach cancer.

## Summary

Humanised IgG4 with an Fc engineered to minimise FcγR binding (reducing macrophage-mediated T-cell clearance). US approvals: second-line ESCC (March 2024), first-line HER2-negative gastric/GEJ with chemotherapy (December 2024, RATIONALE-305), first-line ESCC PD-L1 ≥1% with chemotherapy (March 2025, RATIONALE-306). Also the PD-1 partner in HERIZON-GEA-01 with zanidatamab. Approved in China across many indications since 2019.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Tevimbra
- Code: BGB-A317
- Modality: Monoclonal antibody (anti-PD-1)
- Mechanism: PD-1 blockade with reduced Fcγ receptor engagement.
- Approvals: China 2019: Classical Hodgkin lymphoma (first); subsequently urothelial, NSCLC, HCC, ESCC, gastric, nasopharyngeal; US 2024: Second-line ESCC after chemotherapy; first-line HER2-negative gastric/GEJ with chemotherapy (PD-L1 ≥1); US 2025: First-line ESCC, PD-L1 ≥1%, with platinum chemotherapy
- Dosing: Intravenous; 200 mg every 3 weeks

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Tislelizumab
- FDA approval, first-line ESCC: https://www.onclive.com/view/fda-approves-first-line-tislelizumab-plus-chemotherapy-for-unresectable-or-metastatic-escc

## Connected records

- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [Hepatocellular carcinoma](https://onco.cc/cancers/hcc/), [Nasopharyngeal carcinoma](https://onco.cc/cancers/nasopharyngeal/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Oesophageal cancer](https://onco.cc/cancers/esophageal/), [Oesophageal squamous cell carcinoma](https://onco.cc/cancers/oesophageal-squamous-cell-carcinoma/), [PD-L1-high gastric cancer](https://onco.cc/cancers/gastric-pdl1-high/), [Recurrent and metastatic nasopharyngeal carcinoma](https://onco.cc/cancers/recurrent-metastatic-nasopharyngeal-carcinoma/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [PD-1](https://onco.cc/targets/pd1/)
- companies: [Anbogen Therapeutics](https://onco.cc/companies/anbogen-therapeutics/), [BeOne Medicines (formerly BeiGene)](https://onco.cc/companies/beone/)
- terms: [Fc engineering / effector function](https://onco.cc/terms/fc-effector/), [Immune-related adverse events (irAEs)](https://onco.cc/terms/irae/)
- trials: [- IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorec](https://onco.cc/trials/nct06856837/), ["Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer"](https://onco.cc/trials/nct06829355/), [A Phase 1/2 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Sol](https://onco.cc/trials/nct06427941/), [A Phase 3 Study of Sosimerasib in Combination With IN10018 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutatio](https://onco.cc/trials/nct07833202/), [A Phase II Clinical Study of LBL-024 Combination Therapy in Patients With Advanced Solid Tumour[Substudy 03(ESCC)]](https://onco.cc/trials/nct07331155/), [A Phase II Clinical Study of the Efficacy and Safety of Tislelizumab Combined With Fruquintinib and Chidamide in the Treatment of Unresectable or Advanced Micro](https://onco.cc/trials/nct06218888/), [A Phase II Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumour[Substudy 04]](https://onco.cc/trials/nct07390383/), [A Phase II Study of Tislelizumab as Adjuvant Therapy for Patients With Stage II and Stage III Colon Cancer and dMMR/MSI.](https://onco.cc/trials/nct05231850/), [A Phase II Study of Tislelizumab Plus Anlotinib Consolidation After Chemoradiotherapy in LS-SCLC](https://onco.cc/trials/nct07815223/), [A Prospective, Phase II Trial Using ctDNA to Initiate Post-operation Boost Therapy After NAC in TNBC](https://onco.cc/trials/nct04501523/), [A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer](https://onco.cc/trials/nct06312982/), [A Study Comparing BL-B01D1 Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Pa](https://onco.cc/trials/nct07502300/), [A Study Comparing QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy in Participants Wih Treatment-naïve Extensive-Stage Sm](https://onco.cc/trials/nct07802821/), [A Study Evaluating BL-B01D1 in Combination With a PD-1/VEGF Bispecific Antibody Versus Tislelizumab Plus Platinum-doublet Chemotherapy as First-line Treatment f](https://onco.cc/trials/nct07739186/), [A Study Evaluating HS-10370 Plus Platinum-based Doublet Chemotherapy With or Without Adebrelimab vs. Tislelizumab Plus Chemotherapy as First-Line Therapy in Pat](https://onco.cc/trials/nct07822542/), [A Study Investigating the Efficacy and Safety of Alcestobart (LBL-007) Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus ](https://onco.cc/trials/nct05609370/), [A Study of ABT-301 Plus Tislelizumab With Bevacizumab in pMMR/Non-MSI-H Locally Advanced or mCRC](https://onco.cc/trials/nct07244705/), [A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer](https://onco.cc/trials/nct05990127/), [A Study of BL-B01D1 in Combination With Tislelizumab ±5-Fluorouracil Versus Platinum-Based Chemotherapy Plus Tislelizumab as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus02)](https://onco.cc/trials/nct07554456/), [A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.](https://onco.cc/trials/nct07315750/), [A Study of FC084CSA in Combination of Tislelizumab in Patients With Advanced Malignant Solid Tumors](https://onco.cc/trials/nct06499350/), [A Study of LM-168 Combined With Other Anti-tumor Treatments in Participants With Advanced Solid Tumors](https://onco.cc/trials/nct07669415/), [A Study of SKB518 in Patients With Lung Cancer](https://onco.cc/trials/nct07019675/), [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 Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer](https://onco.cc/trials/nct05635708/), [A Study to Evaluate Efficacy and Safety of Tislelizumab Plus Chemotherapy for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Adenocarcinoma and Esophageal Squamous Cell Carcinoma in Racial and Ethnic Minority Patients in the United States](https://onco.cc/trials/nct07554521/), [A Study to Evaluate Long-term Safety of Zanubrutinib Regimens in Participants With B-Cell Malignancies Who Participated in BeiGene Parent Studies of Zanubrutinib](https://onco.cc/trials/nct04170283/), [A Study to Investigate the Antitumor Activity, Safety, Tolerability, and Pharmacokinetics of BGB-A445 in Combination With Tislelizumab in Participants](https://onco.cc/trials/nct05661955/), [Addition of Platinum-based Chemotherapy to Tislelizumab in PD-L1high Metastatic Non-small Cell Lung Cancer With a High Tumor Burden](https://onco.cc/trials/nct07715396/), [Adjuvant PD-1 Blockade for High-risk Stage-II DMMR/MSI-H Colorectal Cancer](https://onco.cc/trials/nct06520683/), [AK112 in Combination With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer](https://onco.cc/trials/nct05840016/), [An Adaptive-design Prospective Cohort Study of Watch and Wait Strategy in Patients With Locally Advanced Rectal Cancer](https://onco.cc/trials/nct04443543/), [ASKB589 in Combination With CAPOX and PD-1 Inhibitors in Patients With Advanced, and Unresectable G/GEJ Cancer.](https://onco.cc/trials/nct05632939/), [CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Locally Recurrent Colorectal Cancer](https://onco.cc/trials/nct06881537/), [Clinical Studies for the Treatment of Advanced Solid Tumors](https://onco.cc/trials/nct06825494/), [Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint In](https://onco.cc/trials/nct06745908/), [Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)](https://onco.cc/trials/nct04379635/), [Dose Escalation/Expansion Study of Mavrostobart (PT199), an Anti-CD73 mAb, Administered Alone and in Combination With a PD-1 Inhibitor or Chemotherapy](https://onco.cc/trials/nct05431270/), [Efficacy Study of Digoxin Combined With Serplulimab and Chemotherapy in First-Line Treatment of MSS Advanced Colorectal Cancer](https://onco.cc/trials/nct07025850/), [Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities](https://onco.cc/trials/nct06722183/), [Gem+Nab-P+LEN+TIS for Advanced Unresectable BTC (GALENT-BT)](https://onco.cc/trials/nct06963060/), [HDAC Inhibitor Combination With Chemoimmunotherapy in the Neoadjuvant Treatment of pMMR Locally Advanced Colon Cancer](https://onco.cc/trials/nct06709885/), [HERIZON-GEA-01](https://onco.cc/trials/herizon-gea-01/), [IN10018 Combination Therapy in Treatment-naïve ES-SCLC](https://onco.cc/trials/nct06030258/), [Low Rectal Cancer Treated With Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy](https://onco.cc/trials/nct07561060/), [Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer](https://onco.cc/trials/nct05360277/), [Neoadjuvant CAPOX Plus Tislelizumab vs CAPOX in MSS High-Risk Locally Advanced Colon Cancer](https://onco.cc/trials/nct07132008/), [Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal Cancer](https://onco.cc/trials/nct05479240/), [Neoadjuvant Fruquintinib Plus Tislelizumab Combined With mCapeOX Versus CapeOX for Mid-high pMMR/MSS Locally Advanced Rectal Cancer](https://onco.cc/trials/nct06443671/), [Neoadjuvant Tislelizumab, Gemcitabine, Cisplatin and S-1 for Resectable High-risk Cholangiocarcinoma](https://onco.cc/trials/nct06903273/), [Organ Preservation With Tislelizumab and Total Neoadjuvant Therapy in Patients With Low Rectal Cancer: RELIEVE -01 Study](https://onco.cc/trials/nct06390982/), [Phase III Clinical Study of HB0025 Combined With Chemotherapy Versus Tislelizumab Combined With Chemotherapy as First-Line Treatment for Advanced Nonsquamous No](https://onco.cc/trials/nct07383116/), [Phase III Study of RC148 Plus Chemotherapy Versus Tislelizumab Plus Chemotherapy as First-Line Treatment for Non-Squamous Non-Small Cell Lung Cancer Without Act](https://onco.cc/trials/nct07829549/), [Phase III Study of SHR-8068 Combined With Adebrelimab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in the Treatment of Locally Adva](https://onco.cc/trials/nct07170995/), [Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for BRPC](https://onco.cc/trials/nct06573398/), [RATIONALE-302](https://onco.cc/trials/rationale-302/), [RATIONALE-306](https://onco.cc/trials/rationale-306/), [Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other](https://onco.cc/trials/nct07468071/), [Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer](https://onco.cc/trials/nct07469306/), [SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma](https://onco.cc/trials/nct07700667/), [Stereotactic Body Radiotherapy Followed by Tislelizumab Plus Platinum-based Chemotherapy Versus Tislelizumab Plus Platinum-based Chemotherapy as Neoadjuvant The](https://onco.cc/trials/nct06598527/), [Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors](https://onco.cc/trials/nct05651022/), [Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation](https://onco.cc/trials/nct04699188/), [Study of Tislelizumab and Platinum-based Chemotherapy Combination With H1 Receptor Antagonist（Diphenhydramine）in Advanced and Metastatic Non-Small Cell Lung Can](https://onco.cc/trials/nct06704620/), [Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma](https://onco.cc/trials/nct03967977/), [Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined With Tislelizumab, Liposomal Irinotecan, and Capecitabine in the Treatment of pMMR Locally](https://onco.cc/trials/nct07104604/), [SYHX2011 in Combination With Carboplatin and Enlonstobart as First-Line Therapy for Squamous Non-Small Cell Lung Cancer](https://onco.cc/trials/nct07662811/), [SYS6010 Combined With Enlonstobart Versus Immunotherapy+ Platinum-based Chemotherapy for Patients With PD-L1-Positive Locally Advanced or Metastatic NSCLC（SYNST](https://onco.cc/trials/nct07633873/), [The Effects of Neoadjuvant Tislelizumab Combined With Chemotherapy in Locally Advanced MSS Rectal Cancer](https://onco.cc/trials/nct06254521/), [Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors](https://onco.cc/trials/nct03736889/), [Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer](https://onco.cc/trials/nct05841134/), [Tislelizumab Combined with Nab-Paclitaxel for First-Line Treatment of Advanced Triple-Negative Breast Cancer with Bone Metastasis，an Exploratory, Single-Arm, Mu](https://onco.cc/trials/nct06538896/), [tislelizUMaB in canceR Patients With molEcuLar residuaL Disease](https://onco.cc/trials/nct06332274/), [Tislelizumab in Combination With Bevacizumab and Capecitabine in Advanced Solid Tumors With Evaluation in Immunotherapy-Resistant and Central Nervous System Dis](https://onco.cc/trials/nct07681297/), [Tislelizumab in People With Colorectal Cancer](https://onco.cc/trials/nct06529523/), [Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer.](https://onco.cc/trials/nct06940388/), [Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant NSCLC](https://onco.cc/trials/nct06456138/), [Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients](https://onco.cc/trials/nct05771181/)
- ideas: [Biomarker-directed first-line quadruplets in gastric cancer](https://onco.cc/ideas/idea-biomarker-quadruplet-gastric/)
- people: [Jie Wang](https://onco.cc/people/wang-jie-cams/), [John Oyler](https://onco.cc/people/oyler-john/), [Shun Lu](https://onco.cc/people/lu-shun/)
- 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/)

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