Polatuzumab vedotin

FDA-approved

Polivy; DCDS4501A

Target

CD79B · CD79B

Sponsor

Genentech/Roche

Indication

CD79B+ DLBCL

Target family

Immunoglobulin superfamily

RP2D dose

1.8 mg/kg

Q3WRP2D

Multi-organ toxicity

Fingerprint & organ drill-down

Also reported

0%severity100%

Assessed · clear

true 0%

No data

never assessed

1 adverse-event term

Ocular

Any-grade

1.2%

G3+

RP2D

sagittal schematic · Partial

↳

Tissues shaded by reported adverse-event rate.

Cornea

Express.

Limbus

Express.

Conjunctiva

Express.

Lens

Express.

Retina / RPE

Express.

0 nTPM

Dominant tissue

Surface subtype

Unknown

Reversibility

Partial

Reported ocular events

Blurred vision1.2%

n=173

Per-trial detail

Adverse events by trial

GO29365 (Pola+BR / Pola+BG)Phase 1b/2see line_contextn=38CTCAE NRC

CT.gov NCT02257567 Serious AE table (regulatory-serious; proxy for >=G3) NCT02257567

149 adverse-event terms · 19 systems · expand a system below

Infections20

HERPES ZOSTER

10.5%

4/38

RESPIRATORY TRACT INFECTION

10.5%G3+ 2.6%

4/38

ORAL HERPES

7.9%

3/38

UPPER RESPIRATORY TRACT INFECTION

7.9%

3/38

URINARY TRACT INFECTION

7.9%

3/38

PNEUMONIA

5.3%G3+ 18.4%

2/38

BRONCHITIS

5.3%

2/38

NASOPHARYNGITIS

5.3%

2/38

ORAL INFECTION

—G3+ 2.6%

PLEURAL INFECTION BACTERIAL

—G3+ 2.6%

RESPIRATORY TRACT INFECTION VIRAL

—G3+ 2.6%

SEPSIS

—G3+ 2.6%

CLOSTRIDIUM DIFFICILE COLITIS

—G3+ 2.6%

DIVERTICULITIS

—G3+ 2.6%

GASTROENTERITIS

—G3+ 2.6%

HEPATITIS E

—G3+ 2.6%

COVID-19 PNEUMONIA

—G3+ 2.6%

INFECTION

2.6%

1/38

LOWER RESPIRATORY TRACT INFECTION

2.6%

1/38

ORAL CANDIDIASIS

2.6%

1/38

GI18

Investigations14

Pulmonary14

Metabolic12

Neurologic (other)12

General9

Musculoskeletal8

Dermatologic8

Hematologic7

Cardiac6

Psychiatric5

Renal5

Vascular4

Injury2

Other2

Ear1

Immune1

Neoplasms1

Construct

Molecular anatomy

Antibody

IgG1

Humanized

Linker

Cleavable

3.5

DAR

Payload

MMAE

Tubulin inhibitor

Linker structureC28H40N6O7

[H]OC([H])([H])c1c([H])c([H])c(N([H])C(=O)[C@@]([H])(N([H])C(=O)[C@@]([H])(N([H])C(=O)C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])N2C(=O)C([H])=C([H])C2=O)C([H])(C([H])([H])[H])C([H])([H])[H])C([H])([H])C([H])([H])C([H])([H])N([H])C(=O)N([H])[H])c([H])c1[H]

Payload structureC39H67N5O7

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

Antibody

Antibody & Fc engineering

Antibody

MCDS4501A (polatuzumab)

Isotype

IgG1

Origin

Humanized

Fc modifications

None

Glycoengineering

Standard

Effector silencing

None

FcγR binding

Retained

C1q binding

Retained

Target KD (nM)

0.02

Epitope / domain

CD79b extracellular Ig-like domain

Linker & conjugation

Linker chemistry

Linker profile

Linker

MC-vc-PAB (vedotin)

Class

Cleavable

Cleavage

Cleavable

Attachment

Cysteine (interchain)

Conjugation

Conventional interchain Cys

Symmetry

Symmetric

DAR (mean)

3.5

DAR homogeneity

Heterogeneous

Plasma t½

6.0 d

Cleavage trigger

Cathepsin B (Val-Cit)

Release control

Conditional

Hydrophilicity mask

None

Platform

vcMMAE / Seagen

Cell line

CHO

Formula

C28H40N6O7

Linker MW

572.663 Da

Linker TPSA

200.03 Å²

Linker xLogP

0.6769

ADCdb linker

LIN0SQEDQ

In-vitro stability

Stability note

acMMAE t½ 4.43–7.98 d in Japanese R/R B-NHL Ph1 (Tanizaki 2021); population PK in POLARIX (Lu 2024) confirms ~6 d; conventional Cys vc-MMAE

Payload

Payload & physicochemistry

Payload profile

Payload

MMAE

Class

Auristatin

Mechanism

Tubulin inhibitor

Released catabolite

Unconjugated MMAE

Mechanistic subtype

Tubulin-auristatin

Stereochem / salt

Bystander

Yes

PAMPA rank

718 Da

XLogP3

4.1

logD₇.₄

2.7

TPSA

150 Å²

pKa

9.1 pKa

Charge pH 7.4

H-bond donors

H-bond acceptors

IC50 (HCEC)

Formula

C39H67N5O7

PubChem CID

11542188

ADCdb payload

PAY0FSXOW

Plasma protein binding (%)

71 %

Hydrophobicity · logD₇.₄

hydrophilic −2+2.7+4 lipophilic

Bioactivity note

ADCdb reports clinical efficacy in relapsed/refractory DLBCL (ORR up to ~76% in combination therapy); no explicit free-payload IC50 or ADC binding affinity value was listed on the ADCdb page or PubChem entry. ADCdb therapeutic target for the payload: Microtubule (MT) disruption (

Dosing & regimen

Dosing

RP2D dose

1.8 mg/kg

Schedule

Q3W

Route

Fractionated

n at RP2D

435

Dose basis

TBW

Trial phase

Approved

Dose-OAE available

Tox summary basis

RP2D

ADA rate (%)

1.4 %

Pharmacology

Clinical pharmacokinetics

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

	Intact ADC	Free payload
Cmax	688ng/mL+2	3.19ng/mL+2
AUC	2040day*ng/mL+2	31.0day*ng/mL+2
t½	12.2days	3.74days
CL	0.9L/day	—
Vd	3.15L	—

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

1.2 %

OAE grade 3+

0 %

OAE data status

reported

Severity (weighted)

0.4

Keratopathy

Conjunctival

Dry eye

Blurred vision

1.2 %

Dominant tissue

Surface subtype

Unknown

Grading scale

CTCAE v4.03

Reversibility

Partial

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

Cornea (central)

0 %

Cornea (limbal)

0 %

Conjunctiva

0 %

RPE

Retina (HPA)

0 nTPM

Cross-trial comparability · source-verified

Ascertainment: Symptom-driven reportingScale: CTCAE v4Denominator: RP2D⚠ Not comparable: symptom-driven ascertainment

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

1.8 mg/kg

Day 2 of Cycle 1 then Day 1 of Cycles 2-6, 21-day cycles

1.2%

n=173 · GO29365 (expanded safety population)

see line_context

20%

n=10 · Obin + Pola + Venetoclax

see line_context

10%

n=20 · ROMULUS (Pola+anti-CD20 arms)

see line_context

7.5%

n=40 · ROMULUS (Pola+anti-CD20 arms)

see line_context

5.9%

n=17 · Pola + R-CHP/G-CHP 1L DLBCL

see line_context

5.3%

n=38 · GO40516 (Mosun + CHP-Pola)

see line_context

n=40 · Pola + Lenalidomide + G/R

see line_context

n=20 · GO29365 (Pola+BR / Pola+BG)

see line_context

n=20 · GO29365 (Pola+BR / Pola+BG)

see line_context

4.5%

n=22 · GO40516 (Mosun + CHP-Pola)

see line_context

2.9%

n=35 · Pola-R-ICE

see line_context

2.5%

n=40 · Pola + Venetoclax + G/R

see line_context

2.4%

n=41 · Pola + Venetoclax + G/R

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

polatuzumab-vedotin

Approval status

FDA-approved

Approval year

2019

UniProt

P40259

ADCdb ADC

DRG0QWZIT

ADCdb antibody

ANI0WTRRK

ADCdb target

TAR0KZVDX

Primary source

POLIVY DailyMed label (Mar 2026); imputed from >=10% threshold

Aliases & development codes

Polivy; DCDS4501A

Notes

5% imputed; CD79B absent from cornea/conjunctiva