^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    Tevimbra (tislelizumab)

    i
    Other names: BGB-A317, BGB A317, VDT482
    Company:
    BeiGene
    Drug class:
    PD1 inhibitor
    Related drugs:
    4d
    Evaluation of The Efficacy And Safety of PD-1 + IL-2 Combined With Capox Treatment After Loop Colostomy Surgery in Left-sided Colorectal Cancer Patients Complicating Acute Obstruction (clinicaltrials.gov)
    P1/2, N=27, Not yet recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P1/2 trial • Tumor mutational burden • Surgery
    |
    IL2 (Interleukin 2)
    |
    Tevimbra (tislelizumab)
    5d
    CAPOX + Bevacizumab + Tirelizumab Treating PDL1 CPS < 5 GEA (clinicaltrials.gov)
    P2, N=30, Recruiting, Chinese PLA General Hospital | Trial completion date: Oct 2023 --> Jun 2025 | Trial primary completion date: Apr 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 negative
    |
    Avastin (bevacizumab) • Tevimbra (tislelizumab) • capecitabine • oxaliplatin
    5d
    Organ Preservation With Tislelizumab and Total Neoadjuvant Therapy in Patients With Low Rectal Cancer: RELIEVE -01 Study (clinicaltrials.gov)
    P2, N=46, Not yet recruiting, Fudan University
    New P2 trial
    |
    Tevimbra (tislelizumab) • capecitabine • oxaliplatin
    6d
    ICI Rechallenge for Advanced NSCLC With Long-Term Response to First-Line ICI (clinicaltrials.gov)
    P2, N=27, Not yet recruiting, Peking Union Medical College Hospital
    New P2 trial • Checkpoint inhibition • IO biomarker • Metastases
    |
    Keytruda (pembrolizumab) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab)
    9d
    Enhancing survival outcomes in stage Ⅲ gastric/esophagogastric junction cancer: a retrospective study of immune checkpoint inhibitors and adjuvant chemotherapy based on real-world data (PubMed, Zhonghua Wei Chang Wai Ke Za Zhi)
    Of them, 85 received pembrolizumab, 10 received sintilimab, 8 received tislelizumab, 4 received camrelizumab, 2 received toripalimab, and 1 received pabocizumab. The adjuvant chemotherapy regimens used among the chemotherapy alone group includes SOX regimen (132 cases), XELOX (102 cases), S-1 monotherapy (44 cases), and other regimens (15 cases)...Subgroup analysis showed that stage IIIC (HR=0.416, 95%CI: 0.184~0.940), aged ≥60 years (HR=0.336, 95%CI: 0.121~0.934) and extranodal invasion (HR=0.378, 95%CI: 0.170~0.839) were associated with benefit from the combined immune adjuvant chemotherapy, while no association was observed for MMR, HER-2 or EBER status. Stage III gastric/esophagogastric junction cancer patients may benefite from postoperative immune checkpoint inhibitor combined with adjuvant chemotherapy in real-world settings.
    Retrospective data • Journal • Checkpoint inhibition • Real-world evidence • Real-world
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-1 (Programmed cell death 1)
    |
    HER-2 positive • MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • Tyvyt (sintilimab) • Loqtorzi (toripalimab-tpzi) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab) • capecitabine • oxaliplatin
    9d
    Genomic Biomarker-guided Neoadjuvant Therapy for Prostate Cancer (SEGNO) (clinicaltrials.gov)
    P2, N=40, Recruiting, The First Affiliated Hospital of Xiamen University
    New P2 trial • Metastases
    |
    cisplatin • docetaxel • Tevimbra (tislelizumab) • Partruvix (pamiparib) • goserelin acetate • Airui'en (rezvilutamide)
    10d
    BGB-3111-LTE1: Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies (clinicaltrials.gov)
    P3, N=500, Recruiting, BeiGene | Enrolling by invitation --> Recruiting
    Enrollment status
    |
    Tevimbra (tislelizumab) • Brukinsa (zanubrutinib)
    10d
    Biomarker-driven targeted therapy in patients with recurrent platinum-resistant epithelial ovarian cancer (BRIGHT): protocol for an open-label, multicenter, umbrella study. (PubMed, Int J Gynecol Cancer)
    To evaluate the efficacy and safety of biomarker-driven combinatorial therapies of pamiparib, tislelizumab, bevacizumab, and nab-paclitaxel in platinum-resistant, recurrent ovarian cancer. Recruitment is estimated to be completed by 2024 and results may be published by 2027. ClinicalTrials.gov: NCT05044871.
    Journal • BRCA Biomarker • PARP Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • CD8 (cluster of differentiation 8)
    |
    BRCA2 mutation • BRCA1 mutation • BRCA wild-type
    |
    Avastin (bevacizumab) • Tevimbra (tislelizumab) • albumin-bound paclitaxel • Partruvix (pamiparib)
    16d
    NeoSCLC-001: PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage SCLC (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Beijing Chest Hospital, Capital Medical University
    New P2 trial
    |
    cisplatin • carboplatin • Tevimbra (tislelizumab) • etoposide IV
    16d
    BTC-BGB: Phase II Study of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P2, N=43, Active, not recruiting, Seoul National University Hospital | Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Jul 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Tevimbra (tislelizumab) • sitravatinib (MGCD516)
    16d
    IRB-2024-311: Tislelizumab Combined With Neoadjuvant Chemotherapy Used in the Perioperative Treatment. (clinicaltrials.gov)
    P2, N=134, Not yet recruiting, Xiangdong Cheng
    New P2 trial • Combination therapy • Metastases
    |
    Tevimbra (tislelizumab) • capecitabine • oxaliplatin
    17d
    Neoadjuvant and Adjuvant Tislelizumab for Nasopharyngeal Carcinoma (clinicaltrials.gov)
    P3, N=450, Active, not recruiting, Sun Yat-sen University | Not yet recruiting --> Active, not recruiting | Trial completion date: Mar 2027 --> May 2028 | Trial primary completion date: Mar 2024 --> May 2026
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    Tevimbra (tislelizumab)
    18d
    A Phase 1/2a Study Evaluating Allocetra-OTS as Monotherapy or in Combination With Anti-PD-1 Therapy for the Treatment of Advanced Solid Tumor Malignancy (clinicaltrials.gov)
    P1/2, N=14, Terminated, Enlivex Therapeutics RDO Ltd. | N=72 --> 14 | Trial completion date: Dec 2024 --> Apr 2024 | Recruiting --> Terminated | Trial primary completion date: Dec 2023 --> Apr 2024; Sponsor decision
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Tevimbra (tislelizumab) • Allocetra (HLA-matched donor mononuclear enriched leukocytes)
    18d
    SPECTRUM: Relapsed or Refractory Primary Diffuse Large B-cell Lymphoma (DLBCL) of the Central Nervous System (CNS) (clinicaltrials.gov)
    P2, N=28, Recruiting, Seoul National University Hospital | Trial completion date: Feb 2024 --> Feb 2026 | Trial primary completion date: Dec 2023 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    Tevimbra (tislelizumab) • pemetrexed
    19d
    Tirelizumab in Combination With Carboplatin and Polymeric Micellar Paclitaxel for Neoadjuvant Therapy in cN+ HNSCC (clinicaltrials.gov)
    P2, N=85, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    New P2 trial • Combination therapy
    |
    carboplatin • Tevimbra (tislelizumab)
    20d
    Phase Ib/II Trail of Neoadjuvant of Tislelizumab Combined With Palbociclib in Patients With Platinum-refractory Bladder Urothelial Carcinoma (clinicaltrials.gov)
    P1/2, N=36, Recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    New P1/2 trial
    |
    PD-L1 expression
    |
    Ibrance (palbociclib) • Tevimbra (tislelizumab)
    20d
    An Phase III Study, Multicenter，Randomized Controlled Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma. (clinicaltrials.gov)
    P3, N=210, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    New P3 trial • Metastases
    |
    cisplatin • gemcitabine • Tevimbra (tislelizumab) • Cosela (trilaciclib)
    23d
    CRISEC: Chemoradiotherapy Plus Immunotherapy Followed by Surgery for Esophageal Cancer (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, Wuhan Union Hospital, China | Recruiting --> Active, not recruiting
    Enrollment closed • Surgery
    |
    Tevimbra (tislelizumab)
    24d
    TOUCH: A Study of Evaluating the Safety and Efficacy of ATG-010 Combined With Chemotherapy Sequential With ATG-010 Monotherapy Maintenance in Peripheral T- and NK/T-cell Lymphoma (clinicaltrials.gov)
    P1/2, N=97, Recruiting, Antengene Corporation | Trial primary completion date: Dec 2023 --> May 2024
    Trial primary completion date
    |
    carboplatin • gemcitabine • Tevimbra (tislelizumab) • ifosfamide • oxaliplatin • etoposide IV • Xpovio (selinexor)
    26d
    PPIO-008S-1 Combined With Tislelizumab in Patients With Primary Residual Node-negative Esophageal Squamous Cell Carcinoma (ESCC) After Radical Resection With Neoadjuvant Immunotherapy Combined With Chemotherapy, PHASE II STUDY (clinicaltrials.gov)
    P2, N=45, Recruiting, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
    New P2 trial
    |
    Tevimbra (tislelizumab) • Teysuno (gimeracil/oteracil/tegafur)
    1m
    Safety and Tolerability of LDRT Plus Concurrent Partial SBRT and Tislelizumab in Patients With Bulky Tumors (clinicaltrials.gov)
    P1, N=9, Not yet recruiting, Sichuan University
    New P1 trial
    |
    Tevimbra (tislelizumab)
    1m
    Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency. (clinicaltrials.gov)
    P1, N=327, Recruiting, Novartis Pharmaceuticals | Trial completion date: Aug 2026 --> Jan 2030 | Trial primary completion date: Aug 2026 --> Jan 2030
    Trial completion date • Trial primary completion date • Mismatch repair • Metastases
    |
    MSI-H/dMMR
    |
    Tevimbra (tislelizumab) • irinotecan • HRO761
    1m
    AdvanTIG-203: Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) in Participants With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=125, Completed, BeiGene | Active, not recruiting --> Completed
    Trial completion
    |
    PD-L1 (Programmed death ligand 1)
    |
    Tevimbra (tislelizumab) • ociperlimab (BGB-A1217)
    1m
    Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy as an Adjuvant Therapy for Pancreatic Cancer (clinicaltrials.gov)
    P1, N=43, Recruiting, Sichuan University
    New P1 trial
    |
    Tevimbra (tislelizumab) • capecitabine
    1m
    HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma (clinicaltrials.gov)
    P=N/A, N=300, Recruiting, Sun Yat-sen University
    New trial • Real-world evidence • Real-world
    |
    5-fluorouracil • Tyvyt (sintilimab) • Lenvima (lenvatinib) • Loqtorzi (toripalimab-tpzi) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab) • oxaliplatin
    1m
    UMBRELLA: tislelizUMaB in canceR Patients With molEcuLar residuaL Disease (clinicaltrials.gov)
    P3, N=717, Not yet recruiting, Gustave Roussy, Cancer Campus, Grand Paris
    New P3 trial
    |
    Tevimbra (tislelizumab)
    1m
    Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Participants With Selected Solid Tumors (clinicaltrials.gov)
    P2, N=84, Completed, BeiGene | Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Feb 2024
    Trial completion • Trial completion date • Combination therapy
    |
    Tevimbra (tislelizumab) • Fruzaqla (fruquintinib)
    1m
    Cadonilimab Plus CapeOX as First-Line Treatment for Advanced GC/GEJC With High TMEscore (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Nanfang Hospital, Southern Medical University | Initiation date: Jan 2024 --> Apr 2024
    Trial initiation date • Metastases
    |
    Tevimbra (tislelizumab) • capecitabine • oxaliplatin • Kaitanni (cadonilimab)
    1m
    ASKB589 in Combination With CAPOX and PD-1 Inhibitor in Patients With Advanced or Metastatic GC/GEJ Adenocarcinoma (clinicaltrials.gov)
    P3, N=780, Recruiting, AskGene Pharma, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Tevimbra (tislelizumab) • capecitabine • oxaliplatin • ASKB589
    1m
    Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P=N/A, N=240, Recruiting, Sun Yat-sen University
    New trial • Real-world evidence • Real-world • Metastases
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • 5-fluorouracil • Tyvyt (sintilimab) • Loqtorzi (toripalimab-tpzi) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab) • oxaliplatin • epirubicin
    1m
    Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Clinically Node-negative Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=154, Recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    New P2 trial • Surgery
    |
    cisplatin • carboplatin • Tevimbra (tislelizumab) • albumin-bound paclitaxel
    2ms
    Intracranial response pattern, tolerability and biomarkers associated with brain metastases in non-small cell lung cancer treated by tislelizumab plus chemotherapy. (PubMed, Transl Lung Cancer Res)
    Patients received tislelizumab (200 mg) plus pemetrexed (500 mg/m2) and carboplatin (AUC =5) on day 1 every 3 weeks for 4 cycles, followed by maintenance with tislelizumab plus pemetrexed. Similar intracranial efficacy was observed in tumors with different PD-L1 and TMB levels, while alterations in cytokine receptors pathway predicted higher iORR (P=0.081), prolonged systematic PFS &lsqb;hazard ratio (HR) =0.16, P=0.021] and overall survival (OS) (HR =0.71, P=0.029). Untreated or irradiated BMs in NSCLC follows a conventional response and progression pattern under immunochemotherapy with altered cytokine receptors pathway being a potential biomarker for systemic and intracranial outcomes.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    TMB (Tumor Mutational Burden)
    |
    PD-L1 expression
    |
    carboplatin • Tevimbra (tislelizumab) • pemetrexed
    2ms
    Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients (clinicaltrials.gov)
    P2, N=49, Recruiting, Hubei Cancer Hospital | Not yet recruiting --> Recruiting | Initiation date: Sep 2023 --> Feb 2024
    Enrollment open • Trial initiation date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • PD-1 (Programmed cell death 1)
    |
    Keytruda (pembrolizumab) • paclitaxel • Tyvyt (sintilimab) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab)
    2ms
    A Series of Neoadjuvant Chemoradiotherapy Combined With Immunotherapy for Locally Advanced Rectal Cancer: From a Multicenter Phase II Cohort to a Phase III Randomized Controlled Study (clinicaltrials.gov)
    P2/3, N=375, Recruiting, Beijing Friendship Hospital
    New P2/3 trial • Metastases
    |
    Tevimbra (tislelizumab) • oxaliplatin
    2ms
    SITISVEAL: Sitravatinib and Tislelizumab in Patients With Metastatic Uveal Melanoma With Liver Metastases. (clinicaltrials.gov)
    P2, N=16, Active, not recruiting, Grupo Español Multidisciplinar de Melanoma | Recruiting --> Active, not recruiting | N=34 --> 16 | Trial completion date: Aug 2024 --> May 2024
    Enrollment closed • Enrollment change • Trial completion date • Combination therapy • Metastases
    |
    Tevimbra (tislelizumab) • sitravatinib (MGCD516)
    2ms
    ZeTA: A Study to Evaluate Zanubrutinib and Tislelizumab in Progressive Lymphoma Post CAR-T (clinicaltrials.gov)
    P2, N=76, Not yet recruiting, University Health Network, Toronto | Initiation date: Jan 2024 --> Aug 2024
    Trial initiation date • CAR T-Cell Therapy
    |
    Tevimbra (tislelizumab) • Brukinsa (zanubrutinib)
    2ms
    Expression of HER2 in high-grade urothelial carcinoma based on Chinese expert consensus and the clinical effects of disitamab vedotin-tislelizumab combination therapy in the treatment of advanced patients. (PubMed, Front Pharmacol)
    HER2+ expression is positively correlated with higher clinical stage of UC. HER2 targeted ADC drug disitamab vedotin combining with PD-1 inhibitor tislelizumab has shown efficacy, safety and controllable adverse reactions in the treatment of advanced UC.
    Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    Tevimbra (tislelizumab) • Aidixi (disitamab vedotin)
    2ms
    daNIS-3: Study of NIS793 and Other Novel Investigational Combinations With SOC Anti-cancer Therapy for the 2L Treatment of mCRC (clinicaltrials.gov)
    P2, N=205, Active, not recruiting, Novartis Pharmaceuticals | Trial primary completion date: May 2024 --> Sep 2024
    Trial primary completion date • Metastases
    |
    Avastin (bevacizumab) • 5-fluorouracil • Tevimbra (tislelizumab) • oxaliplatin • irinotecan • leucovorin calcium • nisevokitug (NIS793)
    2ms
    Biomarker Analysis of Tislelizumab Combined With Chemotherapy for Perioperative Treatment of G/GEJ Adenocarcinoma (clinicaltrials.gov)
    P=N/A, N=28, Recruiting, Xijing Hospital | N=40 --> 28
    Enrollment change
    |
    Tevimbra (tislelizumab)
    2ms
    Lenvatinib Combined Anti-PD1 Antibody for the Advanced Hepatocellular Carcinoma (clinicaltrials.gov)
    P=N/A, N=600, Completed, Sun Yat-sen University | Trial completion date: Jul 2022 --> Jul 2023
    Trial completion date • Metastases
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tyvyt (sintilimab) • Lenvima (lenvatinib) • Loqtorzi (toripalimab-tpzi) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab)
    2ms
    Exploration of potential biomarkers correlated with efficacy of ociperlimab (anti-TIGIT) plus tislelizumab (anti-PD-1) in 1L PD-L1+ non-small cell lung cancer (NSCLC) (AACR 2024)
    Anti-TIGIT MOA-related genes and signatures correlated with efficacy in ociperlimab + tislelizumab-treated 1L PD-L1+ NSCLC. Combining anti-TIGIT MOA-related factors with PD-L1 expression identified a subgroup of patients with improved efficacy.Table. Efficacy Analyses in Patient SubgroupsCutoff: aTop 1/3; bMedian; cTC≥25%
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • CCR8 (C-C Motif Chemokine Receptor 8) • CD226 (CD226 Molecule)
    |
    PD-L1 expression • TIGIT expression
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Tevimbra (tislelizumab) • ociperlimab (BGB-A1217)
    2ms
    AdvanTIG-302: A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer (clinicaltrials.gov)
    P3, N=660, Recruiting, BeiGene | Trial completion date: May 2025 --> Oct 2026 | Trial primary completion date: Jan 2025 --> Apr 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • Tevimbra (tislelizumab) • ociperlimab (BGB-A1217)