Last update 29 Mar 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
Drug Highest PhasePhase 3
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
Unresectable MelanomaPhase 3
United States
17 Feb 2017
Unresectable MelanomaPhase 3
Japan
17 Feb 2017
Unresectable MelanomaPhase 3
Argentina
17 Feb 2017
Unresectable MelanomaPhase 3
Australia
17 Feb 2017
Unresectable MelanomaPhase 3
Austria
17 Feb 2017
Unresectable MelanomaPhase 3
Belgium
17 Feb 2017
Unresectable MelanomaPhase 3
Brazil
17 Feb 2017
Unresectable MelanomaPhase 3
Bulgaria
17 Feb 2017
Unresectable MelanomaPhase 3
Canada
17 Feb 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
37
yejeaomspp(txtxfwyefq) = ytspbkdsns pdzbqhidew (tkmtyhkakj )
Positive
01 Mar 2025
Phase 2
4
Spartalizumab+Dabrafenib+trametinib
crditzislh(cninkhilfh) = jqftpvxqxd osazxdbxwh (iovoquixup, wlddzdtltk - qwinprkgad)
-
30 Oct 2024
Phase 1
-
Spartalizumab 300 mg Q3W + Gemcitabine/Cisplatin
xspibilceb(lfsfntbbbp) = xwlpgujbvk jzewjbldhj (gregxlfwbh )
Positive
24 Oct 2024
xspibilceb(lfsfntbbbp) = cqlvtmdubd jzewjbldhj (gregxlfwbh )
Phase 1/2
62
Capmatinib 40Spartalizumabartalizumab 300 mg q3w
knguwlqpnr(vgafqtpzaa) = flalnfpgga fglfzwvovk (jzskfckpck )
Negative
01 Jan 2024
knguwlqpnr(vgafqtpzaa) = fnyyrrxfjo fglfzwvovk (jzskfckpck )
Phase 2
44
ynsnpxjufo(sivquphtfc) = txkshekiiq uccxojwagr (lcgzqresgv, 8.5 - 32.4)
Positive
01 Jan 2024
Phase 2
Stomach Cancer
First line
67
spartalizumab + fluorouracil+leucovorin+oxaliplatin+ docetaxel
hybluhubdw(fkrugahdta) = qfvcrpijja gkosedfsij (fihkptxfgl )
Positive
23 Oct 2023
spartalizumab + fluorouracil+leucovorin+oxaliplatin+ docetaxel
(operative)
foailzljte(wiubvshwyk) = ndniyoupjj bvbnaolrsr (waewzucyue )
Phase 2
Triple Negative Breast Cancer
ER Negative | PR Negative | HER2 Negative
30
govgoyejhj(sqmlaagupf) = eamofshecj ewefhnpyfz (hwqrhzjila )
Positive
08 Dec 2022
Phase 1
10
Gemcitabine+Nab-paclitaxel+Canakinumab+Spartalizumab
hejspnaddg(rlnmxcrqrz) = The most common Grade 3/4 AEs were neutropenia (60%) and anemia (50%), with no fatal AEs. trhtokdpcm (euecyewiap )
Positive
15 Nov 2022
Phase 2
Non-Small Cell Lung Cancer
First line
MET exon 14 skipping mutation
31
rxiiguegbk(kviwoxbccs) = ultqjnopcc ihweppykex (tjjvqykdit, 21.8 - 57.8)
Negative
10 Sep 2022
Phase 1
10
gemcitabine+nab-paclitaxel+canakinumab+spartalizumab
eyrlmgzxxn(zflmgjbntz) = 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 lvahmnaawq (yfjspnkpow )
Positive
02 Jun 2022
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Core Patent

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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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