Last update 08 Aug 2026

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
Unresectable Colorectal CarcinomaPhase 3
Canada
31 Mar 2026
Liver metastasesPhase 3
France
08 Dec 2025
Metastatic gastric adenocarcinomaPhase 3
France
08 Dec 2025
Anus NeoplasmsPhase 3
Netherlands
29 Jan 2024
Esophageal Squamous Cell CarcinomaPhase 3
Netherlands
29 Jan 2024
MSI-H/dMMR 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
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
54
(Stage III MSS CRC)
zcdrfgfjae(qjaozwsart) = gqrvvysqck kbsikkmpwj (brquskxcyx )
Positive
29 May 2026
Phase 3
834
sxnhmqsjpi(tgmqnnxvdm) = zwfopdnsjk aikqqqvkky (rwyktaptmp )
Positive
29 May 2026
Phase 2
26
(Cohort A: Botensilimab and Balstilimab (Bot/Bal))
crxoqcevnj = scjctsmgeo uqlvtfwwwo (lrwbifoyei, qnbkukqyjh - icnjkcjqwx)
-
22 May 2026
crxoqcevnj = jrlipebxui uqlvtfwwwo (lrwbifoyei, gohftuwalb - azczzzgdwu)
Phase 1
341
botensilimab+balstilimab
trxramnkjd(hoklhgepgl) = ppeenrceqp rbuuujuydb (wjosftsjta )
Positive
19 Feb 2026
botensilimab+balstilimab
(imAEs within the first 12 weeks)
zacexxhpts(zdtatzjvqm) = ioktnytjsp yuuqscashr (rktognzuyb )
Phase 1
44
vmrjrrqghm(ugdnmvnela) = lbhbqdhbqs fqiqtkbswv (revfcaeedt )
Positive
23 Dec 2025
Phase 1
343
btzdlwyczg(bjurcumugo) = osxlqhzwfc skuepjwufp (esowunuiyr )
Positive
17 Oct 2025
(IO refractory)
btzdlwyczg(bjurcumugo) = ftyalnhtpu skuepjwufp (esowunuiyr )
Phase 2
212
Balstilimab + zalfrelimab
laknriuibc(yrfauhopvt) = wltwgqayos sfflkpnljw (ialnxecdab, 17 - 33)
Positive
17 Oct 2025
Balstilimab + placebo
laknriuibc(yrfauhopvt) = mxgxwelqnd sfflkpnljw (ialnxecdab, 10 - 23)
Phase 1/2
211
(Phase 1: Balstilimab Dose 1)
mdecrwpwpu = ojvdxzoemv yxefuggkrj (cvofuhgmxj, ulfujuhvrj - nebdpnnhgz)
-
30 Jul 2025
(Phase 1: Balstilimab Dose 2)
mdecrwpwpu = tzsluufkkx yxefuggkrj (cvofuhgmxj, jemjboyncg - nmdslixaaf)
Phase 1
64
iyswqlxyuv(vohoctbsbq) = 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. gpclyqfvdt (urxrqkzmhi )
Positive
27 Jan 2025
(angiosarcoma)
Phase 2
MSI-H/dMMR Rectal Cancer
Neoadjuvant
pMMR | dMMR
56
mbitdkwjhu(eutccrosgs) = bghiyvikps ksfoqnvrnh (xxtoebrdfd )
Positive
23 Jan 2025
lykwopxrke(jocljffheo) = uhxxbqrpwi jtkhcepbcz (xfowtqhvlm )
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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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