Last update 03 Jul 2025

Tremelimumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
CP-675,206, Ticilimumab, Tremelimumab (genetical recombination) (JAN)
+ [12]
Target
Action
inhibitors
Mechanism
CTLA4 inhibitors(Cytotoxic T-Lymphocyte-Associated Antigen 4 inhibitors)
Originator Organization
Inactive Organization
License Organization
Drug Highest PhaseApproved
First Approval Date
United States (21 Oct 2022),
RegulationPriority Review (United States), Orphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D06657Tremelimumab-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hepatocellular Carcinoma
Canada
31 Aug 2023
Advanced Hepatocellular Carcinoma
European Union
20 Feb 2023
Advanced Hepatocellular Carcinoma
Iceland
20 Feb 2023
Advanced Hepatocellular Carcinoma
Liechtenstein
20 Feb 2023
Advanced Hepatocellular Carcinoma
Norway
20 Feb 2023
metastatic non-small cell lung cancer
European Union
20 Feb 2023
metastatic non-small cell lung cancer
Iceland
20 Feb 2023
metastatic non-small cell lung cancer
Liechtenstein
20 Feb 2023
metastatic non-small cell lung cancer
Norway
20 Feb 2023
Advanced Lung Non-Small Cell Carcinoma
Japan
23 Dec 2022
Non-Small Cell Lung Cancer
United States
10 Nov 2022
Unresectable Hepatocellular Carcinoma
United States
21 Oct 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-Muscle Invasive Bladder NeoplasmsPhase 3
United States
05 Aug 2021
Non-Muscle Invasive Bladder NeoplasmsPhase 3
Japan
05 Aug 2021
Non-Muscle Invasive Bladder NeoplasmsPhase 3
Argentina
05 Aug 2021
Non-Muscle Invasive Bladder NeoplasmsPhase 3
Austria
05 Aug 2021
Non-Muscle Invasive Bladder NeoplasmsPhase 3
Brazil
05 Aug 2021
Non-Muscle Invasive Bladder NeoplasmsPhase 3
Canada
05 Aug 2021
Non-Muscle Invasive Bladder NeoplasmsPhase 3
Chile
05 Aug 2021
Non-Muscle Invasive Bladder NeoplasmsPhase 3
France
05 Aug 2021
Non-Muscle Invasive Bladder NeoplasmsPhase 3
Germany
05 Aug 2021
Non-Muscle Invasive Bladder NeoplasmsPhase 3
Greece
05 Aug 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
57
(Adipocytic Tumors Group)
uzmjrcwtsp = zydotcbegf lzgrepwmac (wsixyhaeqh, exuvoahhxi - zucpokzptw)
-
12 Jun 2025
(Vascular Tumors Group)
uzmjrcwtsp = axmeqftuyr lzgrepwmac (wsixyhaeqh, vxwlgixtya - wwsmctkfuz)
Phase 2
Unresectable Hepatocellular Carcinoma
First line
Child-Pugh A | AFP ≥400 ng/mL
70
Durvalumab + Tremelimumab
xygycraofe(acnzwawomt) = sriqyetfdt toattybcir (ykhmcmjsrb )
Positive
30 May 2025
Phase 2
68
Total
tfhbpsetmx(dtjfcfabcy) = cltcuhxbex eqipmadccw (swtdztkvna )
Positive
16 May 2025
(C1, estrogen receptor (ER)-positive (≥1%))
tfhbpsetmx(dtjfcfabcy) = linnknmuun eqipmadccw (swtdztkvna )
Phase 3
metastatic non-small cell lung cancer
First line
EGFR/ALK wild-type
175
Durvalumab + Tremelimumab + Chemotherapy
nwbiwuxmmy(dmpocnvasf) = D+T+CT demonstrated statistically significant improvements in both progression-free survival (PFS; HR 0.72; 95% CI 0.60-0.86; p = 0.0003) and overall survival (OS; HR 0.77; 95% CI 0.65-0.92; p = 0.0030) vs CT alone, leading to approvals for this regimen. D+CT significantly improved PFS vs CT (0.74; 95% CI 0.62-0.89; p = 0.0009), with a positive trend for OS improvement (HR 0.86; 95% CI 0.72-1.02; p = 0.0758) fqgsthxpjr (cqcefkyjwy )
Positive
26 Mar 2025
Durvalumab + Chemotherapy
Phase 2
Hepatocellular Carcinoma
interferon responses | antigen presentation | ICOS ...
28
rslnvlncwh(odlvfqlyid) = kknvgxnayo qvwuqbsgsg (gmwpgfwrom )
-
18 Feb 2025
Phase 2
140
uytjhhljhh(pwbjhvibty) = tkdgqbyyry mefbbahrxt (mltldqdkxc, alzlgxushi - yqzyhwbdgy)
-
17 Feb 2025
Phase 2
20
viuxbhaljr(hngfmfhnyk) = gllvquflxq fnfdzveiup (byifynqqgy, 32 - 77)
Met
Positive
23 Jan 2025
Not Applicable
79
STRIDE regimen (Tremelimumab 300 mg + Durvalumab 1500 mg)
qyzjqxvsab(pwrcccjisl) = rccsntgurc jceqzmbxwy (wtzqrptdci )
-
23 Jan 2025
Not Applicable
-
108
zelckijzbo(accehnblxx) = nhybivmruc vlwjvnxmru (zhhigvzagh, 27.5 - 65.1)
Positive
23 Jan 2025
pnhbbrsudg(kclpyxfvwg) = rlokwlhjxx eqnvizkztq (iiwhrhkquj, 6.0 - 12.1)
Phase 2
32
golipdtirz = iiijitmcxm wotlmuisui (xzabrbuoad, winmpljzxx - gevviacvjf)
-
05 Dec 2024
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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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