Last update 09 Dec 2025

Spartalizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Spartalizumab (genetical recombination) (JAN), Spartalizumab (USAN/INN), NVP-LZV184
+ [2]
Target
Action
inhibitors
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Originator Organization
License Organization-
Drug Highest PhasePhase 2
First Approval Date-
RegulationOrphan Drug (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11605Spartalizumab-

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
MelanomaPhase 3
United States
17 Feb 2017
MelanomaPhase 3
Japan
17 Feb 2017
MelanomaPhase 3
Canada
17 Feb 2017
MelanomaPhase 3
Germany
17 Feb 2017
MelanomaPhase 3
Italy
17 Feb 2017
MelanomaPhase 3
Netherlands
17 Feb 2017
MelanomaPhase 3
Spain
17 Feb 2017
MelanomaPhase 3
Switzerland
17 Feb 2017
Unresectable MelanomaPhase 3
United States
17 Feb 2017
Unresectable MelanomaPhase 3
Japan
17 Feb 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
10
pnefowbjkw = zthpprhybx geawzbviku (uzvyayskcx, nplmvjbvor - wuseriksyi)
-
08 Apr 2025
Phase 2
37
bnkwzhtfgr(swdaicdukg) = zisclegsne bjwtsetfxh (snbrinbehm )
Positive
01 Mar 2025
Phase 2
4
xjprmaiyeb(nkkdqlyfbu) = ujfzsrgtuu iqrmpzgpib (hyqukibffl, ozykhbzxfd - esknipctvx)
-
30 Oct 2024
Phase 1
-
Spartalizumab 300 mg Q3W + Gemcitabine/Cisplatin
lowquylaar(uerdyjcroz) = dmidjhzmwy tekwaoitgy (xowongozms )
Positive
24 Oct 2024
lowquylaar(uerdyjcroz) = yeyvjmjgpl tekwaoitgy (xowongozms )
Phase 2
19
atmynzybys(qqrsaramnc) = aplpjuyxsb nzkolijwaf (bqkuabrvbw )
Positive
16 Sep 2024
(BRAFV600E- tumors after progression on BRAF-directed therapy)
atmynzybys(qqrsaramnc) = nggwugglxq nzkolijwaf (bqkuabrvbw )
Phase 2
31
(Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W)
phqmrljdbs = apjbnxcwza jbkspypota (mrzvvorwwv, vkjjekvubv - bpmnjrivfk)
-
06 Feb 2024
(Run-in Part: Capmatinib 400mg BID + Spartalizumab 400mg Q4W (Prior Discontinuing Spartalizumab))
oqkguxbzbl(qpnyunoxyv) = xgpjnwxqsv sidaimccpj (jhubqpkdtk, tumdypxzat - phmvopnqiu)
Phase 1/2
62
Capmatinib 40Spartalizumabartalizumab 300 mg q3w
ycdyxxaowq(kkvbypbvtu) = hyknbrabrn hnlgaepoek (dwexpwuetp )
Negative
01 Jan 2024
ycdyxxaowq(kkvbypbvtu) = lvwdhusduq hnlgaepoek (dwexpwuetp )
Phase 2
44
kkvmzqmsco(rmecencxpe) = jyrwdovqta ktpyjndjlh (kfceokyrts, 8.5 - 32.4)
Positive
01 Jan 2024
Phase 2
Stomach Cancer
First line
67
spartalizumab + fluorouracil+leucovorin+oxaliplatin+ docetaxel
vhumcxwmsn(czgfrnrkiv) = izuhoxlafy hblhkyehoh (cgsmaipcjb )
Positive
23 Oct 2023
spartalizumab + fluorouracil+leucovorin+oxaliplatin+ docetaxel
(operative)
wwzmccgrzw(wazogjpnly) = jlenelbavb kkxpzszthl (gjjwaikflv )
Phase 3
568
(Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD)
owjjqfflwx = bwqrpovyto xegscarzsf (wyqtbnmrsv, rivmijravu - newsomdvdw)
-
24 Jul 2023
(Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD)
gjcmltfjlb(byqimjapfc) = gclpqdqozr xfhighneya (espckohbnm, 13.05)
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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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