TEVIMBRA (islelizumab-jsgr)
TEVIMBRA is indicated for the treatment of Esophageal Cancer; Esophageal Squamous Cell Carcinoma; Gastric Cancer; Gastroesophageal Junction Adenocarcinoma.
How TEVIMBRA Works
Tislelizumab-jsgr binds to the PD-1 receptor on T cells to block its interaction with the ligands PD-L1 and PD-L2. Normally, when these ligands bind to PD-1, they inhibit T-cell proliferation and cytokine production, which can allow tumors to evade the immune system. By blocking this pathway, the drug releases the inhibition of the immune response and restores the body’s anti-tumor activity.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2024-03-13
- Patent Cliff
- 2031
- Routes
- INJECTION, SOLUTION, INTRAVENOUS
- Dosage Forms
- INJECTABLE, INJECTION
TEVIMBRA Approval History
What TEVIMBRA Treats
4 indicationsTEVIMBRA is approved for 4 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Esophageal Cancer
- Esophageal Squamous Cell Carcinoma
- Gastric Cancer
- Gastroesophageal Junction Adenocarcinoma
TEVIMBRA Target & Pathway
ProTarget
An immune checkpoint receptor on T-cells that acts as an 'off switch' for immune responses. Cancer cells often exploit PD-1 by expressing its ligands (PD-L1/PD-L2), allowing tumors to evade immune detection. Blocking PD-1 releases this brake, enabling T-cells to recognize and attack cancer cells.
Pathway Context
PD-1 on T-cells binds to PD-L1/PD-L2 on tumor cells, suppressing immune attack
A protein expressed on tumor cells and immune cells that binds to PD-1 on T-cells, suppressing immune responses. Many cancers overexpress PD-L1 to avoid immune attack. Blocking PD-L1 prevents this immune suppression, allowing the body's T-cells to fight cancer.
A second ligand for PD-1, expressed on antigen-presenting cells and some tumors. PD-L2 binds PD-1 with higher affinity than PD-L1 but is less widely expressed. Drugs blocking PD-1 prevent both PD-L1 and PD-L2 interactions.
TEVIMBRA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TEVIMBRA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TEVIMBRA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TEVIMBRA
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
272 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04746924 results posted | AdvanTIG-302 BGB-A317-A1217-302, CTR20211476/CTR20211464 | Ph 3 | terminated | A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer |
| NCT06596473 | BG-C477-101 CTR20244563 | Ph 1 | recruiting | A Study of BG-C477 in Participants With Advanced Solid Tumors |
| NCT06487858 | BGB-R046-101 | Ph 1 | terminated | A Study of BGB-R046 as Monotherapy and in Combination With Tislelizumab in Solid Tumors |
| NCT07414836 | BG-C0979-101 2025-524857-15-00 | Ph 1 | recruiting | A First-in-Human Study of BG-C0979 in Adults With Advanced Solid Tumors |
| NCT05661955 | BGB-A317-A445-201 CTR20223270 | Ph 1, Ph 2 | active not recruiting | A Study to Investigate the Antitumor Activity, Safety, Tolerability, and Pharmacokinetics of BGB-A445 in Combination With Tislelizumab in Participants With Select Advanced Solid Tumors. |
| NCT07554521 | BGB-A317-217 | Ph 2 | recruiting | 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 |
| NCT07565740 | 2026-891 | Ph 1 | recruiting | Intranasal WSK-IM05 Vaccine Plus Tislelizumab as Neoadjuvant Therapy for HPV+ OPSCC |
| NCT04164199 | BGB-A317-290-LTE1 2019-002554-23, 2023-508883-31-00 | Ph 3 | active not recruiting | Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies |
| NCT07019675 | SKB518-II-02 | Ph 2 | recruiting | A Study of SKB518 in Patients With Lung Cancer |
| NCT05981703 | BGB-A317-26808-101 CTR20240210 | Ph 1 | recruiting | A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors |
| NCT06745908 | ResQ201A-NSCLC | Ph 3 | recruiting | 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 |
| NCT07040956 | 2025 (196) | Ph 2 | recruiting | A Clinical Trial Comparing Low-Dose RT + Targeted Therapy+ Immunotherapy vs Targeted Therapy+ Immunotherapy Alone as Neoadjuvant Therapy in Operable HNSCC Patients. |
| NCT07099547 | ZG005-007 | Ph 2 | recruiting | Study of ZG005 in Combination With Platinum-Based Chemotherapy in Participants With Advanced Biliary Tract Carcinoma |
| NCT06349837 | ECLIPSE-02 | Ph 1 | recruiting | Safety and Tolerability of LDRT Plus Concurrent Partial SBRT and Tislelizumab in Patients With Bulky Tumors |
| NCT07030140 | SDZLEC2024-364-03 | Ph 2 | recruiting | Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline/Unresectable Hilar Cholangiocarcinoma |
| NCT07561983 BEACON-Lung | KY-2025-346-03 | Ph 2 | not yet recruiting | Tislelizumab Plus Chemotherapy and BACE for Unresectable NSCLC |
| NCT07561060 TNTIT | TNTIT | Ph 1, Ph 2 | recruiting | Low Rectal Cancer Treated With Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy |
| NCT07554456 | BL-B01D1-315 | Ph 2, Ph 3 | not yet recruiting | 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) |
| NCT07453875 TRIUNITE06 | DP2025458 | Ph 1 | not yet recruiting | LDRT Sequential NIPS Immunochemotherapy for Peritoneal Metastasis of Gastric and Colorectal Cancer |
| NCT06536868 | [2024] YX No. 274 | Ph 2 | recruiting | Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC |
| NCT05253118 SPECTRUM | SPECTRUM | Ph 2 | active not recruiting | Relapsed or Refractory Primary Diffuse Large B-cell Lymphoma (DLBCL) of the Central Nervous System (CNS) |
| NCT03967977 | BGB-A317-310 CTR20190543 | Ph 3 | active not recruiting | Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma |
| NCT07353294 | SYSKY-2025-837-02 | Ph 1 | enrolling by invitation | Propranolol With Tislelizumab Plus GC in Neoadjuvant Bladder UC |
| NCT05519865 | CDM206 | Ph 2 | completed | A Study of Tucidinostat Combined With Tislelizumab as First-line Treatment in Advanced NSCLC |
| NCT07502300 | BL-B01D1-314 | Ph 3 | not yet recruiting | A Study Comparing BL-B01D1 Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer(PANKU-Lung07) |
| NCT06233981 | NCC4247 | Ph 2 | completed | Phase II Study of Moderate-dose Hypofractionated RT Combined With Tislelizumab for HCC With Diffuse Tumor Thrombosis |
| NCT06427941 | BGB-B2033-101 2025-524136-19-00, jRCT2051260010 | Ph 1 | recruiting | A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors |
| NCT05152147 HERIZON-GEA-01 | ZWI-ZW25-301 2021-000296-36, jRCT2061230026 | Ph 3 | active not recruiting | A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers |
| NCT06233942 | BG-C9074-101 jRCT2031250755 | Ph 1 | recruiting | Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors |
| NCT05635708 | BGB-LC-201 CTR20230892, 2022-502738-18-00 | Ph 2 | active not recruiting | A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer |
| NCT07531979 | PROGRESS | Ph 2 | not yet recruiting | Prospective, Open-label, Multi-cohort Study of Becotatug Vedotin With Tislelizumab and Chemotherapy in Esophageal Squamous Cell Carcinoma - Phase 2 |
| NCT07528274 | EC-2026-0049 | Ph 2 | recruiting | Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure |
| NCT03957590 results posted | BGB-A317-311 CTR20190198 | Ph 3 | completed | A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell Carcinoma |
| NCT07518706 | 2508012438 | Ph 2 | not yet recruiting | Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin |
| NCT07290985 AACR-ADOPT-GEA | AACR-ADOPT-GEA | Ph 2 | not yet recruiting | AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas |
| NCT06422520 | BGB-C354-101 2024-513280-11-00 | Ph 1 | active not recruiting | A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors |
| NCT07136077 | 2025-0696 NCI-2025-06047 | Ph 2 | recruiting | A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy |
| NCT06848465 | DP2024348 | Ph 1 | recruiting | LDRT Combined With Immunochemotherapy for Colorectal Cancer With Liver Metastasis |
| NCT07468071 KontRASt-R | CJDQ443B12105B 2025-523537-26-00 | Ph 1, Ph 2 | not yet recruiting | 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 Study Treatments |
| NCT03744468 results posted | BGB-900-102 U1111-1278-0027, 2022-500694-14 | Ph 1, Ph 2 | completed | Study of Surzebiclimab (BGB-A425) and Alcestobart (LBL-007) in Combination With Tislelizumab in Advanced Solid Tumors |
| NCT05807776 | 2211001174 | Ph 2 | completed | Tislelizumab Monotherapy or Combined With Lenvatinib as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma. |
| NCT07502768 EpiRev-NKT | SHCA-NKT-2601 | Ph 1, Ph 2 | not yet recruiting | Tislelizumab Plus Zeprumetostat for Relapsed or Refractory NK/T-Cell Lymphoma |
| NCT06868732 | JSKN016-102 | Ph 1 | recruiting | Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC |
| NCT05984602 | 22-01205 | Ph 1 | active not recruiting | A Phase IB Study to Determine the Safety and Tolerability of Canakinumab and Tislelizumab in Combination With Nab-Paclitaxel and Gemcitabine in the Neo-adjuvant Treatment of Patients With Pancreatic Cancer |
| NCT05982522 | IN10018-017 | Ph 1, Ph 2 | withdrawn | IN10018 Combination Therapy in Previously-treated Solid Tumors |
| NCT04387084 | 0S-20-1 NCI-2020-01590, 0S-20-1 | Ph 1 | active not recruiting | Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy |
| NCT06585488 | BGB-53038-101 2024-514704-13-00 | Ph 1 | recruiting | A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplification |
| NCT04379635 | BGB-A317-315 CTR20200821 | Ph 3 | active not recruiting | Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC) |
| NCT04699188 KontRASt-01 | CJDQ443A12101 2020-004129-22 | Ph 1, Ph 2 | active not recruiting | Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation |
| NCT07475026 | 2512012685 | Ph 3 | not yet recruiting | A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence |
Showing 50 of 272 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TEVIMBRA FDA Label Details
Indications & Usage
FDA Label (PDF)TEVIMBRA is indicated for the treatment of Esophageal Cancer; Esophageal Squamous Cell Carcinoma; Gastric Cancer; Gastroesophageal Junction Adenocarcinoma.
Track TEVIMBRA with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment