Last update 15 Jul 2025

Tislelizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Tirelizumab, Tiselizumab, Tislelizumab (USAN/INN)
+ [7]
Target
Action
inhibitors
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
China (26 Dec 2019),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Special Review Project (China), Priority Review (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11487Tislelizumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Esophageal Carcinoma
Japan
27 Mar 2025
PD-L1 positive Esophageal Squamous Cell Carcinoma
United States
03 Mar 2025
Locally Advanced Gastric Adenocarcinoma
European Union
19 Dec 2024
Locally Advanced Gastric Adenocarcinoma
Iceland
19 Dec 2024
Locally Advanced Gastric Adenocarcinoma
Liechtenstein
19 Dec 2024
Locally Advanced Gastric Adenocarcinoma
Norway
19 Dec 2024
Locally Advanced Gastroesophageal Junction Adenocarcinoma
European Union
19 Dec 2024
Locally Advanced Gastroesophageal Junction Adenocarcinoma
Iceland
19 Dec 2024
Locally Advanced Gastroesophageal Junction Adenocarcinoma
Liechtenstein
19 Dec 2024
Locally Advanced Gastroesophageal Junction Adenocarcinoma
Norway
19 Dec 2024
Metastatic gastric adenocarcinoma
European Union
19 Dec 2024
Metastatic gastric adenocarcinoma
Iceland
19 Dec 2024
Metastatic gastric adenocarcinoma
Liechtenstein
19 Dec 2024
Metastatic gastric adenocarcinoma
Norway
19 Dec 2024
Metastatic Gastroesophageal Junction Adenocarcinoma
European Union
19 Dec 2024
Metastatic Gastroesophageal Junction Adenocarcinoma
Iceland
19 Dec 2024
Metastatic Gastroesophageal Junction Adenocarcinoma
Liechtenstein
19 Dec 2024
Metastatic Gastroesophageal Junction Adenocarcinoma
Norway
19 Dec 2024
Resectable Lung Non-Small Cell Carcinoma
China
16 Oct 2024
Extensive stage Small Cell Lung Cancer
China
25 Jun 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
stomach adenocarcinomaNDA/BLA
European Union
17 Oct 2024
Unresectable Lung Non-Small Cell CarcinomaNDA/BLA
Canada
01 Feb 2024
Squamous Cell CarcinomaNDA/BLA
China
06 Sep 2018
Colorectal CancerPhase 3
France
16 Apr 2025
Colorectal CancerPhase 3
France
16 Apr 2025
Lung CancerPhase 3
France
16 Apr 2025
Lung CancerPhase 3
France
16 Apr 2025
Non-small cell lung cancer stage IIIPhase 3
France
16 Apr 2025
Non-small cell lung cancer stage IIIPhase 3
France
16 Apr 2025
Pancreatic CancerPhase 3
France
16 Apr 2025
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
52
IO
(Part 1: Solid Tumor of Any Type (IO-Treated/IO-Na?ve in the Metastatic Setting))
oawqsjkdyp = uqkflsdshb mlcxsbqujp (inqlyavilv, ytipwzheqm - kwkuqmmepc)
-
14 Jul 2025
(Part 2: Cohort A: TNBC (IO-Treated in the Metastatic Setting))
vyijljmjhd = szbwvnahrw nitojpxqrl (nwcybdozuh, gtsesuvfbl - resiapwbrp)
Phase 3
649
Tislelizumab 200 mg + chemotherapy
tatnnqoulh(gxosikcivv) = cufokygijw eywyyhojrs (vfkgdpbtkp )
Positive
05 Jul 2025
Placebo + chemotherapy
tatnnqoulh(gxosikcivv) = djqvdlbhki eywyyhojrs (vfkgdpbtkp )
Phase 3
377
(Tislelizumab + Sitravatinib)
oufnpotqqk(lwjivtqjhw) = uictkzdryj qpeafdbqfj (pkyviqpzzo, eurunkkagh - zmbdazhgiz)
-
29 Jun 2025
(Docetaxel)
oufnpotqqk(lwjivtqjhw) = dgqlvsojno qpeafdbqfj (pkyviqpzzo, hbyubkafli - keiabujdvq)
Phase 2
96
(Arm A: Tislelizumab + Sitravatinib)
byxqbyoisf = ixybdgmvel odlvocmwdn (eahqgeiszc, zlpdaeucjf - wpwlcojkdi)
-
13 Jun 2025
(Arm C: Investigator-chosen Chemotherapy (ICC))
byxqbyoisf = yoxksfmgxj odlvocmwdn (eahqgeiszc, lmgpkrpahw - vbttdtgxml)
Phase 3
Metastatic Esophageal Squamous Cell Carcinoma
Second line
NOTCH1 mutation | neutrophil signatures
-
(NOTCH1 mutation)
ixerpbppod(gbuevrsvmb) = pvrwycwoep ctaqvqyati (xcvtjmttnj )
Positive
01 Jun 2025
ixerpbppod(gbuevrsvmb) = rtxmhcerig ctaqvqyati (xcvtjmttnj )
Not Applicable
Neoadjuvant
T3-4 | N positive | EMVI positive ...
29
Neoadjuvant chemoradiotherapy + Tislelizumab
zbrhgzudke(kyjjolhlyr) = gaywzsasei onecuursxn (fuwfisuqhu )
Positive
30 May 2025
(Surgery only)
xynjcclqvr(rxznwiwaaz) = hflaoasphj mkgtagqpyn (qaheobopqw )
Phase 1
-
BGB-A445 monotherapy
ehbsabqutt(xywcwbwlca) = pudqrhcyvm lvsbhooyiw (jsufbhnilf )
Positive
30 May 2025
BGB-A445 combined with tislelizumab and chemotherapy
axibtlfzvf(cdorvmgipa) = kuwurxwwht jrsltoyliu (jpmokrktzz )
Phase 2
Pancreatic Ductal Adenocarcinoma
Second line
PD-1 antibody | TKI
30
fcnfsiiwyr(dtrcnodyqz) = jdnqdqeegh fcxjingiit (tzxryoslhp, 2.9 - 4.8)
Positive
30 May 2025
Not Applicable
2,107
Tislelizumab with or without chemotherapy
lawgnsvvyh(idcyjzkgax) = RR = 1.36; 95% CI: 1.14-1.61; p = 0.0006, I² = 25% ooakxnzygr (raqjpmhqdd )
Positive
30 May 2025
Chemotherapy alone
Phase 2
17
uosefruhow(mkvjvbvwzj) = zqxsbyuucf tnrgqlphol (asmwrlabsl )
Positive
30 May 2025
No prior systemic therapy
uosefruhow(mkvjvbvwzj) = keiqtfkjrb tnrgqlphol (asmwrlabsl )
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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