Belantamab mafodotin

FDA-approved

Blenrep; GSK2857916; J6M0-mcMMAF

Target

BCMA · TNFRSF17

Sponsor

GSK

Indication

BCMA+ multiple myeloma

Target family

TNF receptor superfamily

RP2D dose

2.5 mg/kg

Q3W (extend to Q6W for events)RP2D

Multi-organ toxicity

Fingerprint & organ drill-down

Also reported

0%severity100%

Assessed · clear

true 0%

No data

never assessed

60 adverse-event terms

Ocular

Any-grade

92%

G3+

77%

RP2D

sagittal schematic · Reversible

↳

Tissues shaded by reported adverse-event rate.

Cornea

86%

Express.

0.4%

Limbus

Express.

0.6%

Conjunctiva

Express.

0.06%

Lens

Express.

Retina / RPE

Express.

0.1 nTPM

Off-target signature

86% corneal toxicity, yet the BCMA target is detected in only 0.4% of central cornea - toxicity is not explained by target expression.

Dominant tissue

Cornea

Surface subtype

Corneal (off-target)

Reversibility

Reversible

Reported ocular events

Keratopathy72.88%

poolednon-seriousn=177

Vision blurred31.07%

poolednon-seriousn=177

Visual acuity reduced23.16%

poolednon-seriousn=177

Corneal oedema10.53%

poolednon-seriousn=19

Eye discharge10%

non-seriousn=10

Xerophthalmia10%

non-seriousn=30

Abnormal sensation in eye10%

non-seriousn=10

Conjunctival oedema10%

non-seriousn=10

Eye allergy10%

non-seriousn=10

Vitreous floaters10%

non-seriousn=10

Eye pain9.6%

poolednon-seriousn=177

Dry eye9.04%

poolednon-seriousn=177

Photophobia9.04%

poolednon-seriousn=177

Blepharitis5.65%

poolednon-seriousn=177

Cataract5.26%

poolednon-seriousn=19

Asthenopia5.26%

poolednon-seriousn=19

Foreign body sensation in eyes5.08%

poolednon-seriousn=177

Visual acuity tests abnormal4.52%

poolednon-seriousn=177

Meibomian gland dysfunction3.95%

poolednon-seriousn=177

Chalazion3.39%

poolednon-seriousn=177

Intraocular pressure increased3.39%

poolednon-seriousn=177

Cataract nuclear2.82%

poolednon-seriousn=177

Conjunctival haemorrhage2.82%

poolednon-seriousn=177

Eye irritation2.26%

poolednon-seriousn=177

Visual impairment2.26%

poolednon-seriousn=177

Cataract cortical1.69%

poolednon-seriousn=177

Eye pruritus1.69%

poolednon-seriousn=177

Diplopia1.69%

poolednon-seriousn=177

Conjunctival hyperaemia1.69%

poolednon-seriousn=177

Conjunctivitis1.69%

poolednon-seriousn=177

Punctate keratitis1.69%

poolednon-seriousn=177

Vitreous haemorrhage1.13%

poolednon-seriousn=177

Corneal opacity1.13%

poolednon-seriousn=177

Glaucoma1.13%

poolednon-seriousn=177

Blindness unilateral1.13%

poolednon-seriousn=177

Cataract subcapsular1.13%

poolednon-seriousn=177

Conjunctivitis bacterial1.13%

poolednon-seriousn=177

Ocular discomfort1.13%

poolednon-seriousn=177

Periorbital oedema1.13%

poolednon-seriousn=177

Periorbital swelling1.13%

poolednon-seriousn=177

Vitreous detachment1.13%

poolednon-seriousn=177

Ocular hyperaemia0.56%

poolednon-seriousn=177

Keratitis0.56%

poolednon-seriousn=177

Conjunctivitis allergic0.56%

poolednon-seriousn=177

Posterior capsule opacification0.56%

poolednon-seriousn=177

Age-related macular degeneration0.56%

poolednon-seriousn=177

Blepharospasm0.56%

poolednon-seriousn=177

Blindness0.56%

poolednon-seriousn=177

Chemical burns of eye0.56%

poolednon-seriousn=177

Cornea verticillata0.56%

poolednon-seriousn=177

Corneal abrasion0.56%

poolednon-seriousn=177

Corneal epithelium defect0.56%

poolednon-seriousn=177

Erythema of eyelid0.56%

poolednon-seriousn=177

Eye injury0.56%

poolednon-seriousn=177

Lacrimation increased0.56%

poolednon-seriousn=177

Night blindness0.56%

poolednon-seriousn=177

Pterygium0.56%

poolednon-seriousn=177

Retinal haemorrhage0.56%

poolednon-seriousn=177

Retinal vein occlusion0.56%

poolednon-seriousn=177

Uveitis0.56%

poolednon-seriousn=177

Per-trial detail

Adverse events by trial

DREAMM 6PHASE1|PHASE2real-worldn=177CTCAE NR (ClinicalTrials.govPooledC

ClinicalTrials.gov NCT03544281 posted results, adverse events module (non-serious; 42/354 pooled across arms)

445 adverse-event terms · 22 systems · expand a system below

Infections57

Upper respiratory tract infection

18.08%poolednon-serious

32/177

COVID-19

10.17%poolednon-serious

18/177

Urinary tract infection

7.91%poolednon-serious

14/177

Lower respiratory tract infection

4.52%poolednon-serious

8/177

Pneumonia

4.52%poolednon-serious

8/177

Rhinovirus infection

3.39%poolednon-serious

6/177

Gastroenteritis

2.82%poolednon-serious

5/177

Nasopharyngitis

2.82%poolednon-serious

5/177

Oral candidiasis

2.82%poolednon-serious

5/177

Respiratory tract infection

2.82%poolednon-serious

5/177

Hordeolum

2.26%poolednon-serious

4/177

Viral upper respiratory tract infection

2.26%poolednon-serious

4/177

Cellulitis

1.69%poolednon-serious

3/177

Escherichia urinary tract infection

1.69%poolednon-serious

3/177

Gingivitis

1.69%poolednon-serious

3/177

Rhinitis

1.69%poolednon-serious

3/177

Influenza

1.13%poolednon-serious

2/177

Respiratory syncytial virus infection

1.13%poolednon-serious

2/177

Respiratory tract infection viral

1.13%poolednon-serious

2/177

Sinusitis

1.13%poolednon-serious

2/177

Skin infection

1.13%poolednon-serious

2/177

Viral infection

1.13%poolednon-serious

2/177

Abscess

0.56%poolednon-serious

1/177

Bacterial disease carrier

0.56%poolednon-serious

1/177

Bronchitis

0.56%poolednon-serious

1/177

Campylobacter colitis

0.56%poolednon-serious

1/177

Campylobacter infection

0.56%poolednon-serious

1/177

Candida infection

0.56%poolednon-serious

1/177

Clostridium difficile infection

0.56%poolednon-serious

1/177

Cystitis

0.56%poolednon-serious

1/177

Device related infection

0.56%poolednon-serious

1/177

Ear infection

0.56%poolednon-serious

1/177

Enterovirus infection

0.56%poolednon-serious

1/177

Epididymitis

0.56%poolednon-serious

1/177

Folliculitis

0.56%poolednon-serious

1/177

Gastrointestinal infection

0.56%poolednon-serious

1/177

Helicobacter gastritis

0.56%poolednon-serious

1/177

Herpes ophthalmic

0.56%poolednon-serious

1/177

Herpes simplex reactivation

0.56%poolednon-serious

1/177

Kidney infection

0.56%poolednon-serious

1/177

Lip infection

0.56%poolednon-serious

1/177

Lower respiratory tract infection viral

0.56%poolednon-serious

1/177

Nail infection

0.56%poolednon-serious

1/177

Nosocomial infection

0.56%poolednon-serious

1/177

Oral herpes

0.56%poolednon-serious

1/177

Parainfluenzae virus infection

0.56%poolednon-serious

1/177

Periodontitis

0.56%poolednon-serious

1/177

Pharyngitis

0.56%poolednon-serious

1/177

Picornavirus infection

0.56%poolednon-serious

1/177

Pneumonia viral

0.56%poolednon-serious

1/177

Prostate infection

0.56%poolednon-serious

1/177

Sepsis

0.56%poolednon-serious

1/177

Streptococcal bacteraemia

0.56%poolednon-serious

1/177

Tinea pedis

0.56%poolednon-serious

1/177

Tooth infection

0.56%poolednon-serious

1/177

Urinary tract infection viral

0.56%poolednon-serious

1/177

Varicella zoster virus infection

0.56%poolednon-serious

1/177

Ocular54

Keratopathy

72.88%poolednon-serious

129/177

Vision blurred

31.07%poolednon-serious

55/177

Visual acuity reduced

23.16%poolednon-serious

41/177

Eye pain

9.6%poolednon-serious

17/177

Dry eye

9.04%poolednon-serious

16/177

Photophobia

9.04%poolednon-serious

16/177

Cataract

6.78%poolednon-serious

12/177

Blepharitis

5.65%poolednon-serious

10/177

Foreign body sensation in eyes

5.08%poolednon-serious

9/177

Visual acuity tests abnormal

4.52%poolednon-serious

8/177

Meibomian gland dysfunction

3.95%poolednon-serious

7/177

Chalazion

3.39%poolednon-serious

6/177

Intraocular pressure increased

3.39%poolednon-serious

6/177

Cataract nuclear

2.82%poolednon-serious

5/177

Conjunctival haemorrhage

2.82%poolednon-serious

5/177

Eye irritation

2.26%poolednon-serious

4/177

Visual impairment

2.26%poolednon-serious

4/177

Asthenopia

1.69%poolednon-serious

3/177

Cataract cortical

1.69%poolednon-serious

3/177

Conjunctival hyperaemia

1.69%poolednon-serious

3/177

Conjunctivitis

1.69%poolednon-serious

3/177

Diplopia

1.69%poolednon-serious

3/177

Eye pruritus

1.69%poolednon-serious

3/177

Punctate keratitis

1.69%poolednon-serious

3/177

Blindness unilateral

1.13%poolednon-serious

2/177

Cataract subcapsular

1.13%poolednon-serious

2/177

Conjunctivitis bacterial

1.13%poolednon-serious

2/177

Corneal opacity

1.13%poolednon-serious

2/177

Glaucoma

1.13%poolednon-serious

2/177

Ocular discomfort

1.13%poolednon-serious

2/177

Periorbital oedema

1.13%poolednon-serious

2/177

Periorbital swelling

1.13%poolednon-serious

2/177

Vitreous detachment

1.13%poolednon-serious

2/177

Vitreous haemorrhage

1.13%poolednon-serious

2/177

Age-related macular degeneration

0.56%poolednon-serious

1/177

Blepharospasm

0.56%poolednon-serious

1/177

Blindness

0.56%poolednon-serious

1/177

Chemical burns of eye

0.56%poolednon-serious

1/177

Conjunctivitis allergic

0.56%poolednon-serious

1/177

Cornea verticillata

0.56%poolednon-serious

1/177

Corneal abrasion

0.56%poolednon-serious

1/177

Corneal epithelium defect

0.56%poolednon-serious

1/177

Corneal oedema

0.56%poolednon-serious

1/177

Erythema of eyelid

0.56%poolednon-serious

1/177

Eye injury

0.56%poolednon-serious

1/177

Keratitis

0.56%poolednon-serious

1/177

Lacrimation increased

0.56%poolednon-serious

1/177

Night blindness

0.56%poolednon-serious

1/177

Ocular hyperaemia

0.56%poolednon-serious

1/177

Posterior capsule opacification

0.56%poolednon-serious

1/177

Pterygium

0.56%poolednon-serious

1/177

Retinal haemorrhage

0.56%poolednon-serious

1/177

Retinal vein occlusion

0.56%poolednon-serious

1/177

Uveitis

0.56%poolednon-serious

1/177

GI47

Neurologic (other)30

Musculoskeletal30

General27

Investigations27

Dermatologic25

Metabolic23

Cardiac19

Pulmonary19

Injury16

Renal12

Psychiatric12

Neoplasms9

Hematologic8

Ear8

Vascular8

Other7

Hepatic3

Endocrine2

Immune2

Construct

Molecular anatomy

Antibody

IgG1

Humanized

Linker

Non-cleavable

DAR

Payload

Cys-mcMMAF

Tubulin inhibitor

Linker structureC10H13NO4

O=C(O)CCCCCN1C(=O)C=CC1=O

Payload structureC52H83N7O13S

drag · scroll to zoom

CC[C@H](C)[C@@H]([C@@H](CC(=O)N1CCC[C@H]1[C@@H]([C@@H](C)C(=O)N[C@@H](CC2=CC=CC=C2)C(=O)O)OC)OC)N(C)C(=O)[C@H](C(C)C)NC(=O)[C@H](C(C)C)N(C)C(=O)CCCCCN3C(=O)CC(C3=O)SC[C@@H](C(=O)O)N

Antibody

Antibody & Fc engineering

Antibody

J6M0 (belantamab)

Isotype

IgG1

Origin

Humanized

Fc modifications

None^inferred

Glycoengineering

Afucosylated

Effector silencing

None^inferred

FcγR binding

Retained

C1q binding

Retained^inferred

Target KD (nM)

1.61^unver.

Linker & conjugation

Linker chemistry

Linker profile

Linker

mc (non-cleavable)

Class

Non-cleavable

Cleavage

Non-cleavable

Attachment

Cysteine (interchain)

Conjugation

Conventional interchain Cys

Symmetry

Symmetric

DAR (mean)

DAR homogeneity

Heterogeneous

Plasma t½

13.0 d^unver.

Cleavage trigger

Non-cleavable

Release control

Unconditional

Hydrophilicity mask

None^inferred

Cell line

CHO

Formula

C10H13NO4

Linker MW

211.217 Da

Linker TPSA

74.68 Å²

Linker xLogP

0.5564

ADCdb linker

LIN0TAFAV

In-vitro stability

Stability note

acAb t½ 11.5 d after dose 1 → 14.3 d at steady state (Rathi 2021 popPK N=380 DREAMM-2 + DREAMM-1); recent integrated popPK across DREAMM-1/-2/-3/-7/-8 (Ferron-Brady 2025) reports initial t½ 13.0 d → SS 16.8 d (mono) / 19.1 d (combo). Released cys-mcMMAF t½ 10 min–14 h (rapid).

Payload

Payload & physicochemistry

Payload profile

Payload

Cys-mcMMAF

Class

Auristatin

Mechanism

Tubulin inhibitor

Released catabolite

Cys-mcMMAF

Mechanistic subtype

Tubulin-auristatin

Stereochem / salt

Bystander

PAMPA rank

1046.3 Da

XLogP3

1.4

logD₇.₄

-1

TPSA

301 Å²

pKa

3.5 pKa

Charge pH 7.4

-1

H-bond donors

H-bond acceptors

IC50 (HCEC)

Formula

C52H83N7O13S

PubChem CID

86278355

ADCdb payload

PAY0QLDVX

Plasma protein binding (%)

70 %

Hydrophobicity · logD₇.₄

hydrophilic −2-1+4 lipophilic

Bioactivity note

ADCdb (DRG0NDXRU) reports a cell-based EC50 of 30.6 ug/mL on EL4 cells (moderate BCMA expression) and Phase 1 clinical efficacy (ORR 60% at 3.4 mg/kg; median PFS 12 months; median DoR 14.3 months). MMAF is an antimitotic tubulin-polymerization inhibitor.

Dosing & regimen

Dosing

RP2D dose

2.5 mg/kg

Schedule

Q3W (extend to Q6W for events)

Route

Fractionated

n at RP2D

242

Dose basis

TBW

Trial phase

Approved

Dose-OAE available

Yes

Tox summary basis

RP2D

ADA rate (%)

3 %

Pharmacology

Clinical pharmacokinetics

By analyte · FDA label §12.3 + Drugs@FDA clinical-pharmacology reviews

	Intact ADC	Total antibody	Free payload
Cmax	43.7mcg/mL+1	—	0.976ng/mL+1
AUC	3950mcg*h/mL+2	—	94.2ng*h/mL+1
Tmax	at or shortly after end of infusionh (30-min infusion)+1	at or shortly after end of infusionh (30-min infusion)	22.83h
t½	13days+3	—	—
CL	0.901L/day+3	—	—
Vd	10.8L+1	—	—

FDA label §12.3 Drugs@FDA reviewhover a value for dose / population / source · “+N” marks additional reported values

Ocular & expression

Ocular profile & eye-tissue target expression

Target profile

OAE any-grade

92 %

OAE grade 3+

77 %

OAE data status

reported

Severity (weighted)

81.5

Keratopathy

86 %

Conjunctival

Dry eye

51 %

Blurred vision

66 %

Dominant tissue

Cornea

Surface subtype

Corneal (off-target)

Grading scale

Other (KVA)

Reversibility

Reversible

Target expression in eye tissues (HCA detection · HPA bulk)

Cornea (central)

0.4 %

Cornea (limbal)

0.6 %

Conjunctiva

0.06 %

RPE

0 %

Retina (HPA)

0.1 nTPM

Cross-trial comparability · source-verified

Ascertainment: Systematic eye examsScale: OtherDenominator: RP2D⚠ Not comparable: non-CTCAE grading scale

Dose & schedule → ocular toxicity · keratopathy (any-grade) by cohort

0.12 mg/kg

25%

n=4 · DREAMM-1

0.24 mg/kg

25%

n=4 · DREAMM-1

0.48 mg/kg

25%

n=4 · DREAMM-1

0.95 mg/kg

20%

n=10 · DREAMM-5 sub (Nirogacestat)

0.95 mg/kg

Q3W

5.88%

n=34 · DREAMM-5 sub (Nirogacestat)

0.96 mg/kg

33.33%

n=3 · DREAMM-1

1.0 mg/kg

40%

n=10 · DREAMM-5 sub (Niro+Len+Dex)

1.0 mg/kg

Q4W

10%

n=10 · DREAMM-5 sub (Nirogacestat)

1.4 mg/kg

Q4W

40%

n=10 · DREAMM-5 sub (Nirogacestat)

1.4 mg/kg

Q8W

40%

n=10 · DREAMM-5 sub (Isatuximab)

1.9 mg/kg

75%

n=12 · DREAMM-6

1.9 mg/kg

50%

n=4 · DREAMM-5 sub (Dostarlimab)

1.9 mg/kg

33.33%

n=6 · DREAMM-5 sub (OX40/GSK1)

1.9 mg/kg

Q8W

30%

n=10 · DREAMM-5 sub (Isatuximab)

1.9 mg/kg

25%

n=4 · DREAMM-5 sub (Nirogacestat)

1.9 mg/kg

25%

n=4 · DREAMM-6

1.9 mg/kg

22.22%

n=9 · DREAMM-5 sub (Feladilimab)

1.9 mg/kg

8.33%

n=12 · DREAMM-6

1.9 mg/kg

8.33%

n=12 · DREAMM-6

1.9 mg/kg

Q6W

5.88%

n=17 · DREAMM-14 / alt-dosing

1.9 mg/kg

Q3W

n=40 · DREAMM-14 / alt-dosing

1.92 mg/kg

25%

n=4 · DREAMM-1

2.5 mg/kg

100%

n=6 · DREAMM-4

2.5 mg/kg

92.31%

n=13 · DREAMM-6

2.5 mg/kg (cycle 1) then 1.9 mg/kg

IV Q3W (with bortezomib+dexamethasone)

86%

n=242 · DREAMM-7

2.5 mg/kg

70.53%

n=95 · DREAMM-2

2.5 mg/kg

66.67%

n=3 · DREAMM-5 sub (OX40/GSK1)

2.5 mg/kg

Q6WEEKS

46.15%

n=39 · DREAMM-14 / alt-dosing

2.5 mg/kg

Q3W

37.84%

n=37 · DREAMM-5 sub (Nirogacestat)

2.5 mg/kg

25%

n=4 · Japanese dose-escalation (117159)

2.5 mg/kg

16.67%

n=18 · DREAMM-6

2.5 mg/kg

16.67%

n=6 · DREAMM-5 sub (Feladilimab)

2.50 mg/kg

12.5%

n=8 · DREAMM-1

2.5 mg/kg

10%

n=10 · DREAMM-5 sub (Feladilimab)

2.5 mg/kg

8.33%

n=12 · DREAMM-6

2.5 mg/kg

8.33%

n=12 · DREAMM-6

2.5 mg/kg

7.69%

n=13 · DREAMM-6

2.5 mg/kg

6.25%

n=16 · DREAMM-6

3.4 mg/kg

85.71%

n=7 · DREAMM-4

3.4 mg/kg

83.33%

n=12 · DREAMM-6

3.40 mg/kg

33.33%

n=3 · DREAMM-1

3.4 mg/kg

30.3%

n=99 · DREAMM-2

3.4 mg/kg

25%

n=4 · Japanese dose-escalation (117159)

3.40 mg/kg

16.67%

n=6 · DREAMM-1

3.40 mg/kg

8.57%

n=35 · DREAMM-1

3.4 mg/kg

6.25%

n=16 · DREAMM-6

4.60 mg/kg

16.67%

n=6 · DREAMM-1

see arm

100%

n=3 · Bela+Cyclophosphamide+Dex

see arm

100%

n=1 · Post-CAR-T maintenance

see arm

93.33%

n=30 · Real-world care-patterns (RWD)

see arm

90%

n=10 · DREAMM-8 (Japan)

see arm

70%

n=10 · DREAMM-7 (Japan expansion)

see arm

66.12%

n=242 · DREAMM-7

see arm

50%

n=30 · DREAMM-7 (China subpop)

see arm

Q3WEEKS

41.03%

n=39 · DREAMM-14 / alt-dosing

see arm

33.33%

n=3 · Bela+Cyclophosphamide+Dex

see arm

33.33%

n=6 · Hepatic-impairment PK (207497)

—

30%

n=242 · DREAMM 7

see arm

30%

n=10 · Plasmablastic/ALK+ LBCL

see arm

25%

n=4 · Bela+Cyclophosphamide+Dex

see arm

25%

n=4 · Japanese dose-escalation (117159)

see arm

22.67%

n=150 · DREAMM-8

see arm

11.98%

n=217 · DREAMM-3

—

10.53%

n=19 · An Open-label, Dose Escalation Study in Japanese Participants With Relapsed/Refr

see arm

10%

n=10 · DREAMM-5 sub (Niro+Len+Dex)

see arm

Q4W

10%

n=10 · DREAMM-5 sub (Isatuximab)

—

8.67%

n=150 · DREAMM 8

see arm

7.14%

n=14 · DREAMM-5 sub (Niro+Pom)

—

5.99%

n=217 · DREAMM-3

—

0.56%

n=177 · DREAMM 6

Per-cohort rates from the per-trial extraction, sorted by dose. Cross-trial comparison is subject to ascertainment / scale differences (see comparability above) — e.g. an early symptom-driven trial can read lower than a later systematic-exam trial at a higher dose.

Ocular AE grading reference — interspecialty consensus · 6 scales + dose modification

Identity & registry

Identifiers, registry & notes

ADC id

belantamab-mafodotin

Approval status

FDA-approved

Approval year

2020

UniProt

Q02223

ADCdb ADC

DRG0NDXRU

ADCdb antibody

ANI0MSWWH

ADCdb target

TNFRSF17

Primary source

BLENREP PI Section 6.1 / DREAMM-7 (G3/4 77%)

Aliases & development codes

Blenrep; GSK2857916; J6M0-mcMMAF

Notes

Dose-OAE data: DREAMM-1/-2/-7/-8/-14/Q6W extension; charged Cys-mcMMAF catabolite trapped by macropinocytosis in corneal basal cells