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DRUG:

Tevimbra (tislelizumab-jsgr)

i
Other names: BGB-A317, BGB A317, VDT482, BGBA317, VDT 482, VDT-482
Company:
BeOne Medicines
Drug class:
PD1 inhibitor
Related drugs:
1d
ZeTA: A Study to Evaluate Zanubrutinib and Tislelizumab in Progressive Lymphoma Post CAR-T (clinicaltrials.gov)
P2, N=76, Recruiting, University Health Network, Toronto | Trial completion date: Dec 2027 --> Dec 2029 | Trial primary completion date: Apr 2026 --> Apr 2029
Trial completion date • Trial primary completion date
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Tevimbra (tislelizumab-jsgr) • Brukinsa (zanubrutinib)
1d
Enrollment open
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Erbitux (cetuximab) • Mekinist (trametinib) • Tevimbra (tislelizumab-jsgr) • batoprotafib (TNO155) • opnurasib (JDQ443)
2d
HFB-200603-01: A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=83, Active, not recruiting, HiFiBiO Therapeutics | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
Trial completion date • Trial primary completion date
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BRAF (B-raf proto-oncogene)
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BRAF V600
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Tevimbra (tislelizumab-jsgr) • HFB200603
2d
New P3 trial
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
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ALK fusion
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cisplatin • carboplatin • paclitaxel • Tevimbra (tislelizumab-jsgr) • pemetrexed • Enshuxing (enlonstobart) • SYS6010
2d
BGB-C354-101: A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=63, Completed, BeOne Medicines | Active, not recruiting --> Completed | N=120 --> 63 | Trial completion date: Jan 2027 --> May 2026 | Trial primary completion date: Dec 2026 --> May 2026
Trial completion • Enrollment change • Trial completion date • Trial primary completion date • First-in-human
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Tevimbra (tislelizumab-jsgr)
4d
Association of baseline immune cell composition with CAR-T cell expansion and survival in Relapsed/Refractory large B-Cell lymphoma. (PubMed, J Transl Med)
Baseline immune cell composition may associate with CAR-T expansion and outcomes in R/R LBCL. Exploratory subgroup analyses suggested that the direction of association between baseline PD-1 expression and PFS may differ according to receipt of PD-1 inhibitor maintenance therapy (initiated on day 28 post-infusion), though no statistical significance was reached in either subgroup. Current evidence does not support the clinical use of baseline PD-1 expression as a predictive biomarker, and further validation in prospective studies is warranted.
Journal • PD(L)-1 Biomarker • IO biomarker
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CD8 (cluster of differentiation 8) • CD22 (CD22 Molecule) • CD4 (CD4 Molecule)
|
Tevimbra (tislelizumab-jsgr)
5d
Management of locally advanced lynch syndrome rectal cancer during pregnancy with neoadjuvant immunochemotherapy: a case report. (PubMed, Front Oncol)
The patient subsequently underwent neoadjuvant chemoradiotherapy (50.4 Gy in 28 fractions) combined with two cycles of capecitabine plus oxaliplatin (CapeOx) and tislelizumab, achieving significant tumor regression (yT2N0M0). LS-associated rectal cancer during pregnancy requires individualized, multidisciplinary management. Medical termination followed by neoadjuvant immunochemoradiotherapy can optimize maternal outcomes while minimizing fetal and genetic risks.
Journal
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MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • PMS2 (PMS1 protein homolog 2)
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Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin
6d
Intratumoral bicarbonate functions as an adjuvant to potentiate PD-1 blockade in hepatocellular carcinoma. (PubMed, Oncogene)
In a prospective clinical study (ChiCTR2100053537), 28 patients with advanced-stage and 2 with intermediate-stage HCC received Tislelizumab plus intratumoral 5% sodium bicarbonate...In line with our previous work, through this mitochondria-centered mechanism bicarbonate links metabolic reprogramming with innate and adaptive immune activation. Thus, intratumoral bicarbonate functions as a safe and accessible immunometabolic adjuvant that markedly enhances PD-1 blockade efficacy in HCC.
Journal
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CD4 (CD4 Molecule)
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Tevimbra (tislelizumab-jsgr)
7d
Solid-variant primary pulmonary adenoid cystic carcinoma with pleural metastasis and malignant pleural effusion: a rare case report. (PubMed, Front Oncol)
Given the advanced stage, the patient received a systemic combination of tislelizumab, cyclophosphamide, pegylated liposomal doxorubicin, and nedaplatin, initially combined with local intrapleural therapy. This case highlights a diagnostic pitfall in lung tumors exhibiting squamoid immunophenotypes and underscores the necessity of incorporating myoepithelial markers into the diagnostic workup. Furthermore, it provides a cautiously interpreted clinical observation of immune checkpoint inhibitor-based combination therapy in advanced PACC.
Journal • Pleural effusion • PD(L)-1 Biomarker • IO biomarker
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SOX10 (SRY-Box 10) • TP63 (Tumor protein 63)
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Tevimbra (tislelizumab-jsgr) • cyclophosphamide • pegylated liposomal doxorubicin • Aqupla (nedaplatin)
7d
Rapid progression to toxic epidermal necrolysis following switch of PD-1 inhibitors: a case report. (PubMed, Front Med (Lausanne))
This report describes a 69-years-old male with recurrent hypopharyngeal cancer who experienced only recurrent Grade 1 maculopapular rash during treatment with tislelizumab combined with chemotherapy and subsequent maintenance therapy. However, within 2 days after switching to pembrolizumab, his condition deteriorated rapidly into TEN, involving over 95% of the body surface area and multiple mucosal sites including the oral cavity and conjunctivae...Immunohistochemistry demonstrated positive PD-L1 expression but negative PD-1 expression. These pathological findings suggested that alterations in the local cutaneous immune microenvironment following sequential administration of different PD-1 inhibitors might play a critical role in the fulminant progression of TEN.
Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • Tevimbra (tislelizumab-jsgr)
7d
Trial completion
|
temozolomide • Lenvima (lenvatinib) • Tevimbra (tislelizumab-jsgr) • Fruzaqla (fruquintinib) • Partruvix (pamiparib) • Ziihera (zanidatamab-hrii) • Avzivi (bevacizumab-tnjn) • ociperlimab (BGB-A1217) • sitravatinib (MGCD516) • BGB-15025 • BGB-A445 • alcestobart (LBL-007) • surzebiclimab (BGB-A425)
7d
BGB-53038-101: 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 (clinicaltrials.gov)
P1, N=47, Terminated, BeOne Medicines | N=514 --> 47 | Trial completion date: Dec 2026 --> Apr 2026 | Recruiting --> Terminated | Trial primary completion date: Dec 2026 --> Apr 2026; The Sponsor has made the decision to terminate this study due to the lack of promising efficacy, internal prioritization, and highly competitive landscape.
Enrollment change • Trial completion date • Trial termination • Trial primary completion date • First-in-human
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS wild-type
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Erbitux (cetuximab) • Tevimbra (tislelizumab-jsgr)