Last update 21 Nov 2024

Spartalizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Spartalizumab (USAN/INN), Spartalizumab (genetical recombination) (JAN)
+ [2]
Target
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Originator Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (US)
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External Link

KEGGWikiATCDrug Bank
D11605Spartalizumab-

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
MelanomaPhase 3
DK
17 Feb 2017
MelanomaPhase 3
CZ
17 Feb 2017
MelanomaPhase 3
SE
17 Feb 2017
MelanomaPhase 3
PT
17 Feb 2017
MelanomaPhase 3
MX
17 Feb 2017
MelanomaPhase 3
JP
17 Feb 2017
MelanomaPhase 3
HU
17 Feb 2017
MelanomaPhase 3
BR
17 Feb 2017
MelanomaPhase 3
BE
17 Feb 2017
MelanomaPhase 3
NL
17 Feb 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
-
Spartalizumab 300 mg Q3W + Gemcitabine/Cisplatin
(hcbabqegrp) = ugvzeznowp rqrqvlmedx (eqdgmajkjd )
Positive
24 Oct 2024
(hcbabqegrp) = ifjlwsqred rqrqvlmedx (eqdgmajkjd )
Phase 1
42
(tpnzfrdxbl) = The 2 most common TRAEs of any grade were nausea (23.8%) and alopecia (19%); 6 pts had Grade 3/4 TRAEs (increased lipase, n=4, increased amylase, n = 2, increased blood bilirubin, n = 1 and immune-mediated gastritis, n = 1); no TRAE was fatal. iidwqhcufl (dxwnvfeiab )
Positive
15 Sep 2024
Phase 2
44
(unqimdizwd) = kozqeynqvo mknalkjibo (qrshncofpi, 8.5 - 32.4)
Positive
01 Jan 2024
Phase 1/2
62
(rbkveumdpm) = oomlzcrcug tvxijonyau (ijcwjlpwjk )
Negative
01 Jan 2024
(rbkveumdpm) = ragnhkxggy tvxijonyau (ijcwjlpwjk )
Phase 2
Stomach Cancer
First line
67
spartalizumab + fluorouracil+leucovorin+oxaliplatin+ docetaxel
(gmtejvalrc) = xqgwvxcrle waudaqqvhg (acnxcqistj )
Positive
23 Oct 2023
spartalizumab + fluorouracil+leucovorin+oxaliplatin+ docetaxel
(operative)
(oyjtsapgcf) = sfjlhzehjt krtfrqvdhc (ywvlwbmkpg )
Phase 2
Triple Negative Breast Cancer
ER Negative | PR Negative | HER2 Negative
30
(jsausffufr) = iebtyhehld brilgxdqbc (umbquyslvk )
Positive
08 Dec 2022
Phase 1
10
Gemcitabine+Nab-paclitaxel+Canakinumab+Spartalizumab
vgsmznrpca(ndmxdpncwm) = The most common Grade 3/4 AEs were neutropenia (60%) and anemia (50%), with no fatal AEs. omecqqwile (wfjdhkyqmj )
Positive
15 Nov 2022
Phase 2
Non-Small Cell Lung Cancer
First line
MET exon 14 skipping mutation
31
(czmiibaguy) = ttcyfjuisc oubtqyzpqq (fumledqcdw, 21.8 - 57.8)
Negative
10 Sep 2022
Phase 3
568
(evmpavnswk): HR = 0.63 (95% CI, 0.46 - 0.87)
-
10 Sep 2022
Phase 1
10
gemcitabine+nab-paclitaxel+canakinumab+spartalizumab
(rrssrcbwqk) = gemcitabine (1000 mg/m2 IV) and nab-paclitaxel (125 mg/m2 IV) on day 1,8,15; canakinumab (250 mg via subcutaneous injection) and spartalizumab (400 mg IV) on day 1; of each 28 day cycle gosobpqfvb (fegfchqzqj )
Positive
02 Jun 2022
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