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DRUG:

Tevimbra (tislelizumab-jsgr)

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Other names: BGB-A317, BGB A317, VDT482, BGBA317, VDT 482, VDT-482
Company:
BeiGene
Drug class:
PD1 inhibitor
Related drugs:
13h
KontRASt-01: Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation (clinicaltrials.gov)
P1/2, N=344, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Aug 2025 --> Apr 2026 | Trial primary completion date: Aug 2025 --> Apr 2026
Trial completion date • Trial primary completion date • Metastases
|
KRAS (KRAS proto-oncogene GTPase)
|
Tevimbra (tislelizumab-jsgr) • batoprotafib (TNO155) • opnurasib (JDQ443)
16h
A Study of BGB-30813 Alone or in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=200, Recruiting, BeiGene | Active, not recruiting --> Recruiting | N=37 --> 200 | Trial completion date: May 2026 --> Dec 2026 | Trial primary completion date: May 2025 --> Dec 2026
Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
|
TMB-H • MSI-H/dMMR
|
Tevimbra (tislelizumab-jsgr) • BGB-30813
19h
Sorafenib combined with tarexib for first-line treatment of unresectable hepatocellular carcinoma and its predictive role and correlation with PD-L1 CTCs. (PubMed, Front Oncol)
The combination of Tislelizumab and Sorafenib demonstrates promising antitumor activity in the first-line treatment of hepatocellular carcinoma, with a relatively high objective response rate (ORR) and acceptable safety profile. Baseline CTC PD-L1 positivity can serve as a predictive marker for selecting hepatocellular carcinoma patients for PD-1/PD-L1 blockade therapy, and dynamic measurement of CTC changes can be used to monitor treatment efficacy.
Journal • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • PD-L1 negative
|
sorafenib • Tevimbra (tislelizumab-jsgr)
3d
New P3 trial • Metastases
|
cisplatin • Tevimbra (tislelizumab-jsgr) • albumin-bound paclitaxel
5d
Enrollment open • Metastases
|
Erbitux (cetuximab) • Tevimbra (tislelizumab-jsgr)
6d
RATIONALE-314: Tislelizumab Monotherapy Versus Salvage Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma (clinicaltrials.gov)
P3, N=123, Recruiting, BeiGene | Trial completion date: Mar 2025 --> Feb 2026 | Trial primary completion date: Sep 2024 --> Feb 2026
Trial completion date • Trial primary completion date
|
cisplatin • carboplatin • cytarabine • Tevimbra (tislelizumab-jsgr)
8d
New P2 trial • Surgery
|
TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
|
PD-L1 expression
|
Erbitux (cetuximab) • cisplatin • Tevimbra (tislelizumab-jsgr) • albumin-bound paclitaxel
9d
New P2 trial
|
cisplatin • Tevimbra (tislelizumab-jsgr) • albumin-bound paclitaxel
9d
FUTURE: Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities (clinicaltrials.gov)
P2, N=33, Not yet recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
New P2 trial • Combination therapy • IO biomarker
|
Tevimbra (tislelizumab-jsgr) • Lytgobi (futibatinib)
10d
FIL_Tisle-HL: Efficacy and Safety of Frontline Tislelizumab in Patients With de Novo Hodgkin Lymphoma Unsuitable for Standard Frontline Chemotherapy (clinicaltrials.gov)
P2, N=28, Recruiting, Fondazione Italiana Linfomi - ETS | Trial completion date: Apr 2029 --> Nov 2029 | Trial primary completion date: Apr 2027 --> Nov 2027
Trial completion date • Trial primary completion date
|
Tevimbra (tislelizumab-jsgr)
12d
KontRASt-01: Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation (clinicaltrials.gov)
P1/2, N=344, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Mar 2026 --> Aug 2025 | Trial primary completion date: Mar 2026 --> Aug 2025
Trial completion date • Trial primary completion date • Metastases
|
KRAS (KRAS proto-oncogene GTPase)
|
Tevimbra (tislelizumab-jsgr) • batoprotafib (TNO155) • opnurasib (JDQ443)
13d
Cost-effectiveness analysis of tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced gastric or gastroesophageal junction adenocarcinoma: perspectives from the United States and China. (PubMed, Front Pharmacol)
In China, tislelizumab plus chemotherapy is a cost-effective first-line therapy for unresectable GC/GEJC in both ITT and TAP ≥ 5% subgroups. In the US, tislelizumab plus chemotherapy is not cost-effective.
Journal • HEOR • Cost-effectiveness • Cost effectiveness • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Tevimbra (tislelizumab-jsgr)
14d
Chidamide With Immunotherapy for Patients With Locally Advanced or Metastatic Urothelial Carcinoma (clinicaltrials.gov)
P2, N=45, Active, not recruiting, Sun Yat-sen University | Recruiting --> Active, not recruiting | Trial completion date: Sep 2023 --> Oct 2025 | Trial primary completion date: Sep 2022 --> Aug 2024
Enrollment closed • Trial completion date • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Tevimbra (tislelizumab-jsgr) • Epidaza (chidamide)
20d
HDAC Inhibitor Combination with Chemoimmunotherapy in the Neoadjuvant Treatment of PMMR Locally Advanced Colon Cancer (clinicaltrials.gov)
P2, N=100, Recruiting, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
New P2 trial • Metastases
|
Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • Epidaza (chidamide)
22d
BGB-A317-213: Study of Tislelizumab in Participants With Resectable Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
P2, N=70, Completed, BeiGene | Active, not recruiting --> Completed | Trial completion date: May 2026 --> Oct 2024
Trial completion • Trial completion date
|
Tevimbra (tislelizumab-jsgr)
22d
New trial • Metastases
|
Tyvyt (sintilimab) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr) • AiTan (rivoceranib)
22d
Enrollment closed • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Tevimbra (tislelizumab-jsgr) • LBL-007 • surzebiclimab (BGB-A425)
23d
Study to Evaluate the Efficacy and Safety of Immunotherapy With Axitinib in Advanced Collecting Duct Carcinoma (clinicaltrials.gov)
P2, N=30, Recruiting, Peking University Cancer Hospital & Institute | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy • Checkpoint inhibition • Metastases
|
Keytruda (pembrolizumab) • Tevimbra (tislelizumab-jsgr) • Inlyta (axitinib)
23d
Enrollment open
|
Tevimbra (tislelizumab-jsgr) • albumin-bound paclitaxel
23d
New P3 trial • Metastases
|
cisplatin • carboplatin • Tevimbra (tislelizumab-jsgr) • albumin-bound paclitaxel • pemetrexed
23d
New P2 trial • Metastases
|
cisplatin • carboplatin • paclitaxel • Tevimbra (tislelizumab-jsgr)
23d
BGB-A317-ZW25-101: Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab (clinicaltrials.gov)
P1/2, N=71, Completed, BeiGene | Active, not recruiting --> Completed | Trial completion date: Dec 2026 --> Oct 2024
Trial completion • Trial completion date • Combination therapy • Metastases
|
docetaxel • Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • Ziihera (zanidatamab-hrii)
24d
The Effect of Serum Ferritin in irAE (clinicaltrials.gov)
P=N/A, N=1500, Recruiting, Tianjin Medical University Cancer Institute and Hospital
New trial • Adverse events • IO biomarker
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Tyvyt (sintilimab) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr)
28d
QLYY-iCCA-01: HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma (clinicaltrials.gov)
P2, N=28, Active, not recruiting, Qilu Hospital of Shandong University | Recruiting --> Active, not recruiting | Trial primary completion date: May 2024 --> Dec 2024
Enrollment closed • Trial primary completion date
|
Tevimbra (tislelizumab-jsgr) • oxaliplatin • Sulanda (surufatinib)
29d
PD1 Inhibitors Combined With Clostridium Butyricum for Urothelial Carcinoma (clinicaltrials.gov)
P2, N=60, Recruiting, The First Affiliated Hospital with Nanjing Medical University
New P2 trial
|
cisplatin • gemcitabine • Tevimbra (tislelizumab-jsgr)
30d
New P2 trial
|
Tevimbra (tislelizumab-jsgr) • Brukinsa (zanubrutinib)
30d
Special entities of the head and neck region: cancers of the nasopharynx, (para)nasal cavities, salivary glands, and the thyroid gland : Post ASCO 2024 (PubMed, HNO)
In the treatment of locally advanced NPC, a randomized phase III study showed equivalence of induction (ICT) and adjuvant therapy (AT; NCT03306121). PD-1 inhibitors have become established in the palliative therapy of NPC in recent years and could now also play an increasing role in curation: the phase III study "Dipper" showed a significantly better 3‑year event-free survival in patients adjuvantly treated with camrelizumab versus placebo after IT and definitive platinum-containing chemoradiotherapy (dRCT; 89% vs. 80%; NCT03427827). The phase III study "Beacon" showed complete remission in 30.5% of patients after IT with gemcitabine/cisplatin and the PD‑1 inhibitor tislelizumab (three cycles), a rate almost twice as high as with gemcitabine/cisplatin alone (NCT05211232). Intensification of dRCT in NPC using EGFR and VEGF inhibitors appears promising (NCT04447326). Abstracts on salivary gland and nasal and sinus cancers emphasize the importance of targeted therapies. In anaplastic thyroid carcinoma, the combination of a PD‑1 inhibitor and a CTLA4 inhibitor showed a 50% response.
Review • Journal
|
EGFR (Epidermal growth factor receptor)
|
cisplatin • gemcitabine • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr)
1m
New P2 trial
|
Tevimbra (tislelizumab-jsgr)
1m
Combination of Tislelizumab and Chemoradiotherapy in Esophageal Cancer (EC-CRT-002) (clinicaltrials.gov)
P2, N=114, Active, not recruiting, Sun Yat-sen University | Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2025 --> Nov 2025
Enrollment closed • Trial primary completion date • Tumor mutational burden • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8)
|
PD-L1 expression
|
cisplatin • paclitaxel • Tevimbra (tislelizumab-jsgr)
1m
New P2 trial
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • cisplatin • Tagrisso (osimertinib) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • Zelboraf (vemurafenib) • Imfinzi (durvalumab) • gemcitabine • Rozlytrek (entrectinib) • imatinib • 5-fluorouracil • Tyvyt (sintilimab) • Alecensa (alectinib) • Nerlynx (neratinib) • Loqtorzi (toripalimab-tpzi) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr) • Irene (pyrotinib) • Balversa (erdafitinib) • albumin-bound paclitaxel • irinotecan • Orpathys (savolitinib) • epirubicin • vinorelbine tartrate • Partruvix (pamiparib) • Epkinly (epcoritamab-bysp) • Hetronifly (serplulimab) • Enweida (envafolimab) • Vumon (teniposide) • Ariely (adebrelimab)
1m
Concordance Among Three Programmed Death-Ligand 1 (PD-L1) Scoring Methods and Their Association With Clinical Outcomes of Tislelizumab (TIS) Monotherapy in Esophageal Squamous Cell Carcinoma (ESCC) (AIOM 2024)
OS subgroup analysis showed comparable treatment effect by TAP score at 10% cutoff, CPS at cutoff 10, and TC score at 1% cutoff. TAP score and CPS at these cutoffs exhibited substantial concordance. Results indicate that the quicker, visually estimated TAP score and CPS may be interchangeable for clinical measurement of PD-L1 expression in patients with ESCC.
Clinical • Clinical data • PD(L)-1 Biomarker • IO biomarker • Discordant
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
VENTANA PD-L1 (SP263) Assay
|
Tevimbra (tislelizumab-jsgr)
1m
New P1 trial
|
cisplatin • paclitaxel • Tevimbra (tislelizumab-jsgr)
1m
A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer (clinicaltrials.gov)
P1, N=122, Terminated, Novartis Pharmaceuticals | Trial completion date: Jan 2025 --> Sep 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2025 --> Sep 2024; The decision of early termination was made due to business reasons, and was not based on any safety concerns for any of the treatment combinations.
Trial completion date • Trial termination • Trial primary completion date
|
BRAF (B-raf proto-oncogene)
|
BRAF mutation • BRAF V600
|
Mekinist (trametinib) • Tafinlar (dabrafenib) • Tevimbra (tislelizumab-jsgr) • spartalizumab (PDR001) • naporafenib (ERAS-254) • batoprotafib (TNO155) • rineterkib (LTT462)
1m
New P2 trial
|
Tevimbra (tislelizumab-jsgr) • oxaliplatin
1m
New P1/2 trial • Combination therapy • Metastases
|
carboplatin • docetaxel • Lenvima (lenvatinib) • Loqtorzi (toripalimab-tpzi) • Tevimbra (tislelizumab-jsgr) • Zejula (niraparib)
1m
New trial
|
docetaxel • Tevimbra (tislelizumab-jsgr) • oxaliplatin
1m
New P4 trial • Metastases
|
cisplatin • carboplatin • paclitaxel • Tevimbra (tislelizumab-jsgr)
1m
New P2 trial • Metastases
|
Tevimbra (tislelizumab-jsgr) • capecitabine
1m
New P2 trial • Combination therapy • Metastases
|
docetaxel • Tevimbra (tislelizumab-jsgr) • oxaliplatin
1m
New P2 trial
|
PD-L1 (Programmed death ligand 1)
|
Avastin (bevacizumab) • 5-fluorouracil • Tevimbra (tislelizumab-jsgr) • oxaliplatin • leucovorin calcium
1m
New P1 trial • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD276 (CD276 Molecule) • NTRK (Neurotrophic receptor tyrosine kinase)
|
EGFR mutation • HER-2 negative • EGFR wild-type • CD276 expression
|
Tevimbra (tislelizumab-jsgr)
1m
The Efficacy and Safety of Neoadjuvant SBRT Combined With Chemoimmunotherapy in Resectable Locally Advanced HNSCC (ChiCTR2400090395)
P1, N=26, Not yet recruiting, The Tenth Affiliated Hospital, Southern Medical University (Dongguan People's Hospital); The Tenth Affiliated Hospital, Southern Medical University(Do
New P1 trial • Metastases
|
cisplatin • Tevimbra (tislelizumab-jsgr) • albumin-bound paclitaxel