Last update 12 Jul 2024

Tislelizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Tirelizumab, Tiselizumab, Tislelizumab (USAN/INN)
+ [6]
Target
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
CN (26 Dec 2019),
RegulationOrphan Drug (US), Orphan Drug (EU), Priority Review (CN), Conditional marketing approval (CN), Special Review Project (CN)
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External Link

KEGGWikiATCDrug Bank
D11487Tislelizumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Extensive stage Small Cell Lung Cancer
CN
25 Jun 2024
Locally Advanced Esophageal Squamous Cell Carcinoma
AU
30 May 2024
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma
AU
30 May 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma
AU
30 May 2024
Oesophageal squamous cell carcinoma recurrent
AU
30 May 2024
Non-Small Cell Lung Cancer
EU
23 Apr 2024
Non-Small Cell Lung Cancer
IS
23 Apr 2024
Non-Small Cell Lung Cancer
LI
23 Apr 2024
Non-Small Cell Lung Cancer
NO
23 Apr 2024
Squamous non-small cell lung cancer
EU
23 Apr 2024
Squamous non-small cell lung cancer
IS
23 Apr 2024
Squamous non-small cell lung cancer
LI
23 Apr 2024
Squamous non-small cell lung cancer
NO
23 Apr 2024
Locally Advanced Lung Non-Small Cell Carcinoma
EU
19 Apr 2024
Locally Advanced Lung Non-Small Cell Carcinoma
IS
19 Apr 2024
Locally Advanced Lung Non-Small Cell Carcinoma
LI
19 Apr 2024
Locally Advanced Lung Non-Small Cell Carcinoma
NO
19 Apr 2024
metastatic non-small cell lung cancer
EU
19 Apr 2024
metastatic non-small cell lung cancer
IS
19 Apr 2024
metastatic non-small cell lung cancer
LI
19 Apr 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Resectable Lung Non-Small Cell CarcinomaNDA/BLA
CN
19 Jan 2024
Resectable Lung Non-Small Cell CarcinomaNDA/BLA
CN
19 Jan 2024
Squamous Cell CarcinomaNDA/BLA
CN
06 Sep 2018
Esophageal CarcinomaNDA/BLA
US
-
Gastrooesophageal junction cancerPhase 3-30 Jan 2022
HER2 Positive Gastroesophageal AdenocarcinomaPhase 3
AR
09 Nov 2021
HER2 Positive Gastroesophageal AdenocarcinomaPhase 3
AU
09 Nov 2021
HER2 Positive Gastroesophageal AdenocarcinomaPhase 3
BE
09 Nov 2021
HER2 Positive Gastroesophageal AdenocarcinomaPhase 3
CL
09 Nov 2021
HER2 Positive Gastroesophageal AdenocarcinomaPhase 3
FR
09 Nov 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
50
Tislelizumab + Lenvatinib + Capecitabine
uojathhtoq(gsnpqmaekx) = dpvheetppt nfgtzwmknd (rztwyziimk, 47.45 - 74.99)
Positive
27 Jun 2024
Phase 2
Colonic Cancer
Neoadjuvant
Proficient DNA Mismatch Repair (pMMR) | Microsatellite Stable (MSS)
27
ajjwttqtoi(nxvoiyryti) = gohstmfepj cnmvbgfhuc (lvlttofiri )
Positive
27 Jun 2024
Phase 1/2
Advanced gastric carcinoma | Advanced Gastroesophageal Junction Adenocarcinoma
First line
HER2 Negative | Proficient DNA Mismatch Repair (pMMR)
15
wdrxegoeth(ordlndijlk) = One DLT (grade 4 neutropenia) occurred within 28 days in dl #4. ogepvprmho (juvhxibuir )
Positive
27 Jun 2024
Phase 2
17
Tislelizumab plus HAIC
mmufvlsmvj(vwvpaulewh) = qivdbbbulw iwigrzwwhm (oryuyhqisv )
Positive
27 Jun 2024
Tislelizumab plus HAIC
(underwent surgical resection)
arwwdbamlx(idztqnibgu) = uliwcmvpig llemzpfvcj (igxrgfpdun, 5.98 - NR)
Phase 1
216
uctpfwolok(jvermdtfje) = qyaviayfkv ajtwuaybkn (xjkgakvplx, lbkvmjrgac - mlcapdgsta)
-
17 Jun 2024
Phase 2
31
dbvyrpopte(tynrvtfclr) = cwoabpayye vvxgkcfydp (ofkgwinsbq )
Positive
24 May 2024
Phase 2
Colorectal Liver Metastases
RAS Mutation (Activating) | BRAF | RAS Wild Type | ...
35
phaxpixsrq(kgavnsjhsq) = kfshvoxsrh nxatjnauuv (reowtoakjb, 5.36 - 9.82)
Positive
24 May 2024
(left-sided tumor pts)
drvgwykgxe(dyarmdszda) = arzceyatfm jsdmrzaxlz (lnonspafql )
Phase 1
39
uhufskagkm(cvfrloefot) = None kfomfkgkdz (zufwdwxqyl )
Positive
24 May 2024
Phase 2
48
Tislelizumab plus TKI
njaqzrclbf(bpjhzeskkr) = xtcybidwec grwxplktfq (qeuqplkjmc )
Positive
24 May 2024
Tislelizumab
njaqzrclbf(bpjhzeskkr) = cveawxieya grwxplktfq (qeuqplkjmc )
Phase 3
649
Tislelizumab 200 mg
iecopqccav(oapkvucouu): HR = 0.7 (95% CI, 0.59 - 0.83)
Positive
24 May 2024
Placebo
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