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DRUG:

Tevimbra (tislelizumab-jsgr)

i
Other names: BGB-A317, BGB A317, VDT482, BGBA317, VDT 482, VDT-482
Company:
BeiGene
Drug class:
PD1 inhibitor
Related drugs:
1d
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
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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VENTANA PD-L1 (SP263) Assay
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Tevimbra (tislelizumab-jsgr)
3d
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
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EGFR (Epidermal growth factor receptor)
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cisplatin • gemcitabine • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr)
3d
New P1 trial
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cisplatin • paclitaxel • Tevimbra (tislelizumab-jsgr)
4d
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
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BRAF (B-raf proto-oncogene)
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BRAF mutation • BRAF V600
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Mekinist (trametinib) • Tafinlar (dabrafenib) • Tevimbra (tislelizumab-jsgr) • spartalizumab (PDR001) • naporafenib (ERAS-254) • batoprotafib (TNO155) • rineterkib (LTT462)
5d
New P2 trial
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Tevimbra (tislelizumab-jsgr) • oxaliplatin
6d
New P1/2 trial • Combination therapy • Metastases
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carboplatin • docetaxel • Lenvima (lenvatinib) • Loqtorzi (toripalimab-tpzi) • Tevimbra (tislelizumab-jsgr) • Zejula (niraparib)
6d
New trial
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docetaxel • Tevimbra (tislelizumab-jsgr) • oxaliplatin
8d
New P4 trial • Metastases
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cisplatin • carboplatin • paclitaxel • Tevimbra (tislelizumab-jsgr)
8d
New P2 trial • Metastases
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Tevimbra (tislelizumab-jsgr) • capecitabine
8d
New P2 trial
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PD-L1 (Programmed death ligand 1)
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Avastin (bevacizumab) • 5-fluorouracil • Tevimbra (tislelizumab-jsgr) • oxaliplatin • leucovorin calcium
8d
New P2 trial • Combination therapy • Metastases
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docetaxel • Tevimbra (tislelizumab-jsgr) • oxaliplatin
8d
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
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cisplatin • Tevimbra (tislelizumab-jsgr) • albumin-bound paclitaxel
8d
New P1 trial • Combination therapy • Metastases
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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)
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EGFR mutation • HER-2 negative • EGFR wild-type • CD276 expression
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Tevimbra (tislelizumab-jsgr)
11d
SMALLER: Adjuvant PD-1 Blockade for High-risk Stage-II DMMR/MSI-H Colorectal Cancer (clinicaltrials.gov)
P3, N=180, Recruiting, Sun Yat-sen University | Not yet recruiting --> Recruiting
Enrollment open
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5-fluorouracil • Tevimbra (tislelizumab-jsgr) • capecitabine
11d
RATIONALE-311: A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
P3, N=370, Active, not recruiting, BeiGene | Trial completion date: Dec 2024 --> Jun 2026 | Trial primary completion date: Nov 2024 --> Jun 2025
Trial completion date • Trial primary completion date • Combination therapy
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cisplatin • paclitaxel • Tevimbra (tislelizumab-jsgr)
12d
New P2 trial • Metastases
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Tevimbra (tislelizumab-jsgr) • TheraCIM (nimotuzumab)
13d
New P2 trial • Metastases
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Tevimbra (tislelizumab-jsgr)
13d
Synergistic Effects of PD-1 Antibody and Chemotherapy Followed by Surgeon-led Local Treatment in Patients with Limited-metastatic Gastric Cancer (ROSETTE) (clinicaltrials.gov)
P2, N=82, Not yet recruiting, Shanghai Zhongshan Hospital | Trial completion date: Jul 2028 --> Dec 2028 | Initiation date: Jul 2024 --> Nov 2024 | Trial primary completion date: Jul 2027 --> Dec 2027
Trial completion date • Trial initiation date • Trial primary completion date • Metastases
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Opdivo (nivolumab) • Tyvyt (sintilimab) • Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin
17d
Anti-PD-1 immunotherapy for the treatment of metastatic urothelial carcinoma in a kidney transplant recipient: a case report. (PubMed, BMC Nephrol)
This case demonstrates the feasibility of safely achieving stable cancer control in a kidney transplant patient with mUC without encountering graft rejection by using single-agent anti-PD-1 treatment.
Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Metastases
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TMB (Tumor Mutational Burden)
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TMB-H
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Tevimbra (tislelizumab-jsgr)
17d
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 | Recruiting --> Active, not recruiting | Trial completion date: Jan 2027 --> Mar 2026 | Trial primary completion date: Jan 2027 --> Mar 2026
Enrollment closed • Trial completion date • Trial primary completion date
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KRAS (KRAS proto-oncogene GTPase)
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Tevimbra (tislelizumab-jsgr) • batoprotafib (TNO155) • opnurasib (JDQ443)
18d
Enrollment closed
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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cisplatin • carboplatin • paclitaxel • Tevimbra (tislelizumab-jsgr) • pemetrexed • ociperlimab (BGB-A1217) • LBL-007
20d
New P2 trial • Combination therapy
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Tevimbra (tislelizumab-jsgr) • Teysuno (gimeracil/oteracil/tegafur)
21d
Treatment of Relapsed or Refractory Diffuse Large B Cell Lymphoma With Ociperlimab (BGB A1217) in Combination With Tislelizumab (BGB A317) or Rituximab (clinicaltrials.gov)
P1/2, N=53, Completed, BeiGene | Active, not recruiting --> Completed | Trial completion date: Feb 2025 --> Aug 2024
Trial completion • Trial completion date
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PD-L1 (Programmed death ligand 1)
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Rituxan (rituximab) • Tevimbra (tislelizumab-jsgr) • ociperlimab (BGB-A1217)
21d
New P2 trial • Combination therapy
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cisplatin • carboplatin • Tevimbra (tislelizumab-jsgr) • pemetrexed
25d
LBL-007-CN-004: A Phase Ib/II Clinical Trial of LBL-007 Combined With Tislelizumab in the Treatment of Malignant Tumors (clinicaltrials.gov)
P1/2, N=490, Recruiting, Nanjing Leads Biolabs Co.,Ltd | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Oct 2024 --> Oct 2025
Trial completion date • Trial primary completion date • Combination therapy
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cisplatin • gemcitabine • docetaxel • Tevimbra (tislelizumab-jsgr) • LBL-007
28d
DKN-01 in Combination With Tislelizumab and Chemotherapy as First-Line Therapy in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: DisTinGuish. (PubMed, J Clin Oncol)
DKN-01 can be safely combined with frontline fluoropyrimidine/oxaliplatin and tislelizumab and demonstrates encouraging activity independent of PD-L1 expression levels. A randomized phase II trial is ongoing (ClinicalTrials.gov identifier: NCT04363801).
Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • DKK1 (dickkopf WNT signaling pathway inhibitor 1)
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PD-L1 expression • HER-2 negative
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Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • sirexatamab (DKN-01)
1m
Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer (clinicaltrials.gov)
P2, N=35, Not yet recruiting, The Affiliated Hospital of Qingdao University
New P2 trial • Metastases
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Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin
1m
New P2 trial • Combination therapy
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Tevimbra (tislelizumab-jsgr) • Fruzaqla (fruquintinib)
1m
Trial completion
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Tevimbra (tislelizumab-jsgr)
1m
Triple Therapy for Intermediate-advanced HCC With BDTT (TALENP002) (clinicaltrials.gov)
P=N/A, N=20, Recruiting, Fujian Provincial Hospital | Not yet recruiting --> Recruiting
Enrollment open • Real-world evidence • Real-world • Metastases
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Lenvima (lenvatinib) • Tevimbra (tislelizumab-jsgr)
1m
Enrollment closed • Enrollment change • Metastases
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cisplatin • carboplatin • Tevimbra (tislelizumab-jsgr) • albumin-bound paclitaxel
1m
Trial completion • Combination therapy • Metastases
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cisplatin • paclitaxel • 5-fluorouracil • Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin
1m
Case report: Fatal hemoptysis after effective treatment with tislelizumab and anlotinib in pulmonary sarcomatoid carcinoma. (PubMed, Front Oncol)
However, it also represents the first reported case of fatal hemoptysis with this specific treatment regimen. This finding emphasizes the need for increased awareness of this potential complication, especially in patients with centrally located PSC treated with anti-angiogenic agents like anlotinib.
Journal • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1)
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Focus V (anlotinib) • Tevimbra (tislelizumab-jsgr)
1m
Pathological response following neoadjuvant immunotherapy and imaging characteristics in dMMR/MSI-H locally advanced colorectal cancer. (PubMed, Front Immunol)
12 patients received Nivolumab plus Ipilimumab regimen and 8 patients received PD-1 blockades (2 patients were Pembrolizumab, 2 patients were Sintilimab, 4 patients were Tislelizumab) monotherapy. Furthermore, the study suggested that dual immunotherapy could potentially increase the immunotherapy cycle and contribute to a superior pCR rate. However, the conclusion emphasized the need for further prospective clinical trials to validate these results.
Retrospective data • Journal • Metastases
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MSI (Microsatellite instability)
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MSI-H/dMMR
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • Tyvyt (sintilimab) • Tevimbra (tislelizumab-jsgr)
1m
Case report: Successful treatment of advanced urothelial carcinoma with trophoblastic differentiation using Tislelizumab and Disitamab vedotin. (PubMed, Heliyon)
Tumor progression occurred after six cycles of Tislelizumab combined with chemotherapy (gemcitabine and cisplatin) followed by five cycles of Tislelizumab monotherapy. The prognosis of advanced urothelial carcinoma with trophoblastic differentiation is unfavorable, and the available therapeutic options are limited. Combining Tislelizumab with Disitamab vedotin presents a promising anti-tumor strategy that warrants further investigation.
Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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cisplatin • gemcitabine • Tevimbra (tislelizumab-jsgr) • Aidixi (disitamab vedotin)
1m
Immune-related severe pneumonia: A case report (PubMed, Beijing Da Xue Xue Bao Yi Xue Ban)
In this paper, we reported a case of immune checkpoint inhibitor-associated severe pneumonia, referred to the relevant guidelines, introduced its clinical features, laboratory and imaging findings, difficulties encountered in the diagnosis and treatment process, briefly analyzed the causes, and reviewed the possibility of immune-related pneumonia should be considered when respiratory symptoms occurred in patients receiving immunotherapy; the increased ratio of blood neutrophil count to lymphocyte count, and the increased ratio of eosinophil count to lymphocyte count could be used as indicators to indicate immune-related adverse reactions in patients; bronchoalveolar lavage fluid examination and bronchoscopy and lung biopsy were helpful for the diagnosis; when immune checkpoint inhibitor-associated severe pneumonia occurred, in addition to symptomatic and sup-portive treatment, adequate glucocorticoid-based immunosuppressive therapy should be given in time, and combined with cytokines monoclonal antibodies and other biological agents, immunoglobulin co-therapy, but the current indications for the use of biological agents were not fully clear, and the use of high-dose immunosuppressive drugs might cause the risk of severe infection. Therefore, according to the relevant literature and the findings in the process of clinical diagnosis and treatment, this paper proposed that the serum levels of IL-6, TNF-α, CRP and other inflammatory mediators in patients may be used as a quantitative indication to initiate biological agent therapy and accumulate experience for better solving similar problems in the future.
Journal
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IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha)
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Tevimbra (tislelizumab-jsgr)
1m
Node-sparing modified short-course Radiotherapy Combined with CAPOX and Tislelizumab for locally Advanced MSS of Middle and low rectal Cancer (mRCAT): an open-label, single-arm, prospective, multicentre clinical trial. (PubMed, BMC Cancer)
In our research, node-sparing modified radiotherapy combined with immunotherapy probably increased the responsiveness of immunotherapy for MSS/pMMR rectal cancer patients, reduced the occurrence of postoperative rectal fibrosis, and improved survival and quality of life. This is the first clinical trial to utilize a node-sparing radiation strategy combined with chemotherapy and PD-1 blockade in the neoadjuvant treatment of rectal cancer, which may result in a breakthrough in the treatment of MSS/pMMR rectal cancer.
Clinical protocol • Journal • Metastases
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CD8 (cluster of differentiation 8)
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MSI-H/dMMR
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Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin
1m
New trial • Combination therapy • Metastases
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5-fluorouracil • Tyvyt (sintilimab) • Lenvima (lenvatinib) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr)
1m
Phase classification • Combination therapy • Metastases
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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Tevimbra (tislelizumab-jsgr) • BGB-A445
1m
New trial • Combination therapy • Checkpoint inhibition • Metastases
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Keytruda (pembrolizumab) • Avastin (bevacizumab) • Tecentriq (atezolizumab) • sorafenib • 5-fluorouracil • Tyvyt (sintilimab) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr) • AiTan (rivoceranib) • Zepsun (donafenib)
1m
New trial • Combination therapy • Metastases
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5-fluorouracil • Tyvyt (sintilimab) • Lenvima (lenvatinib) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr)