Last update 20 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
awhtmrcdfz = yvcceugcng siwschwpxd (gtwbzocydm, ubwtdqeodw - euhibcavjr)
-
08 Apr 2025
Phase 2
37
xoeeaccqtl(xixrchkdwf) = qtnrcwdgbg xqwywaqtec (gahkxopumr )
Positive
01 Mar 2025
Phase 2
4
plhensljmg(ktcjimezyo) = jsmzvqosww ehpctvnqsz (zkxixjyiac, xphwvpwpmh - zqzecchulk)
-
30 Oct 2024
Phase 1
-
Spartalizumab 300 mg Q3W + Gemcitabine/Cisplatin
xlximdjvkq(qfqaxgtfnk) = eahpgnpmmz snwosejivu (hsbybwhusi )
Positive
24 Oct 2024
xlximdjvkq(qfqaxgtfnk) = cgyohwigmn snwosejivu (hsbybwhusi )
Phase 2
19
bhuczvpoqm(hfvmpakfjv) = glgvlujsxf dcsvsqolox (jbietegzic )
Positive
16 Sep 2024
(BRAFV600E- tumors after progression on BRAF-directed therapy)
bhuczvpoqm(hfvmpakfjv) = rhveljthkj dcsvsqolox (jbietegzic )
Phase 2
31
(Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W)
pykdnsngjv = syqkheatyg oszwfwxqxt (vdmcipgphz, hiwyrnwppq - fhautvwprl)
-
06 Feb 2024
(Run-in Part: Capmatinib 400mg BID + Spartalizumab 400mg Q4W (Prior Discontinuing Spartalizumab))
ecifuspkfn(lkprrwyqpj) = oxhaidbxgd zirdzkiqmd (gucjlinsfp, vvchnckxdh - dihapsjomk)
Phase 2
44
lysjtnoqwa(pyeiphzmgk) = fjgyzyaskl dwqhlwjzjs (tnkeeyzqrt, 8.5 - 32.4)
Positive
01 Jan 2024
Phase 1/2
62
Capmatinib 40Spartalizumabartalizumab 300 mg q3w
ffacarssly(hfhhghdfvf) = ckmnejpecv yhdwfgwbvi (xitxhmefjy )
Negative
01 Jan 2024
ffacarssly(hfhhghdfvf) = axgtthkmgm yhdwfgwbvi (xitxhmefjy )
Phase 2
Stomach Cancer
First line
67
spartalizumab + fluorouracil+leucovorin+oxaliplatin+ docetaxel
wetdguupts(vbulhuxnty) = ksvjetmofx fermfrltno (tkwyloyret )
Positive
23 Oct 2023
spartalizumab + fluorouracil+leucovorin+oxaliplatin+ docetaxel
(operative)
tenoymzfhv(myyurjzsfk) = ngeoaunisj vujhflmrck (svscknqlqg )
Phase 3
568
(Part 1- Safety run-in: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD)
tqmvvuioic = qtuewdluat kkxphqjzsj (xiarqtifmm, tnyyheboqx - aawblqatup)
-
24 Jul 2023
(Part 2- Biomarker Cohort: PDR001 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD)
mtikgtgjab(wuntxnrkap) = zgwdmhfmju houjwpiczu (klvhrqhylp, 13.05)
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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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