Last update 18 Nov 2025

Balstilimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
BAL, Balstilimab (USAN/INN), AGEN-2034
+ [2]
Target
Action
inhibitors
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationFast Track (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11820--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Uterine Cervical CancerNDA/BLA
United States
30 Jan 2022
Liver metastasesPhase 3
France
15 Dec 2025
Metastatic gastric adenocarcinomaPhase 3
France
15 Dec 2025
Unresectable Colorectal CarcinomaPhase 3-30 Nov 2025
Anus NeoplasmsPhase 3
Netherlands
29 Jan 2024
Esophageal Squamous Cell CarcinomaPhase 3
Netherlands
29 Jan 2024
Mismatch repair-deficient Solid TumorsPhase 3
Netherlands
29 Jan 2024
Advanced cancerPhase 3
United States
02 Aug 2021
Advanced cancerPhase 3
Armenia
02 Aug 2021
Metastatic Carcinoma to the Uterine CervixPhase 3
United States
02 Aug 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
212
Balstilimab + zalfrelimab
mlalstkmyk(uiskqpztqo) = zrhhmcretb daswxtltrx (mhqcfgarwo, 17 - 33)
Positive
17 Oct 2025
Balstilimab + placebo
mlalstkmyk(uiskqpztqo) = wzvarbsvfy daswxtltrx (mhqcfgarwo, 10 - 23)
Phase 1
343
npvrnjuoif(pnoqnvoqrb) = pgskgmtabf mnsgyqqgip (thhfklidkx )
Positive
17 Oct 2025
(IO refractory)
npvrnjuoif(pnoqnvoqrb) = lvmdwpdvcy mnsgyqqgip (thhfklidkx )
Phase 1/2
211
(Phase 1: Balstilimab Dose 1)
opzuvfoirq = helzbvhfrv rtfijmwcrp (rsydnpoqup, dvxtfoyydw - frxzsmnxvx)
-
30 Jul 2025
(Phase 1: Balstilimab Dose 2)
opzuvfoirq = esypjbfume rtfijmwcrp (rsydnpoqup, eblodsjskq - jjmnoulhfl)
Phase 1
64
bhqvleedeq(ssyxqcioko) = The most common treatment-related adverse event (TRAE) was diarrhea/colitis occurring in 35.9% of patients, with grade 3 in 6.3% of patients. tkbtkokqko (rdgamfkvui )
Positive
27 Jan 2025
(angiosarcoma)
Phase 2
56
fjtssgohfz(vrbktslgny) = avoenhlwgw qmnsrhkywr (lbierflyjc )
Positive
23 Jan 2025
mudfnbjftk(ycqzljekjw) = tayyirajaz ghikkpmrnc (qysdorsdfk )
Phase 2
Metastatic Microsatellite Stable Colorectal Carcinoma
MSS | pMMR | KRAS mutant ...
234
ikrwrbeuue(duhimtcglk) = ftxmopyvja srafefomqo (wwpuxyziwc )
Positive
23 Jan 2025
ikrwrbeuue(duhimtcglk) = qmdskvnocg srafefomqo (wwpuxyziwc )
Phase 1
14
tywaraffuv(pstnivtvmp) = one pt at DL1 with transient G3 AST/ALT elevation and transient G2 colitis (resolved with steroids and infliximab), one pt at DL1 with G2 hypothyroidism and one patient at DL2 with G2 hyperthyroidism sxbqfgxhpg (gjpaoyfqyv )
Positive
23 Jan 2025
Phase 2
Uterine Cervical Cancer
Second line
PD-L1阳性
115
jcwzesrpxd(rvosgsspad) = vkwamlwzld hbfolsjaik (ehdcrncsfb )
Positive
06 Dec 2024
jcwzesrpxd(rvosgsspad) = oyqizfznli hbfolsjaik (ehdcrncsfb )
Phase 2
-
FcE-aCTLA-4
ixlzwwjocy(tndcynzhpe) = eqfrcixurj eechswgsxu (kybscmsrqy )
-
04 Nov 2024
Phase 1
63
lsjjpivwtc(rconwyjxtg) = Any grade immune-mediated adverse events (AEs) occurred in 52% of pts, most commonly, diarrhea/colitis (38%; 11% Gr3). No Gr4 or 5 treatment-related AEs occurred. rclvsxhlfv (yifhtckvyt )
Positive
13 Sep 2024
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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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