← Atlas
Polatuzumab vedotin FDA-approved Polivy; DCDS4501A
Target family
Immunoglobulin superfamily
RP2D dose
1.8 mg/kg Q3W RP2D
01 Multi-organ toxicity
Fingerprint & organ drill-down Any-grade Grade 3+
Ocular
1.2%
Hepatic
26%
Neutrop.
60%
Thrombo.
32%
Anemia
68%
GI
42%
ILD
1.7%
Neuro.
53%
Also reported Other · 913 · 18 systems
41 adverse-event terms
Ocular Toxicity Target expression Compare
sagittal schematic · Partial
↳ Tissues shaded by reported adverse-event rate.
Reported ocular events
CONJUNCTIVITIS VIRAL 2.94%
VITREOUS DEGENERATION 2.94%
CONJUNCTIVAL HYPERAEMIA 1.22%
CONJUNCTIVAL IRRITATION 1.22%
LACRIMATION INCREASED 0.76%
VISUAL ACUITY REDUCED 0.76%
OCULAR SURFACE SQUAMOUS NEOPLASIA 0.76%
Lacrimation increased 0.7%
CYTOMEGALOVIRUS CHORIORETINITIS 0.31%
Per-trial detail
Adverse events by trial A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obin · PHASE1|PHASE2 — 360 events, n=327 A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relap · PHASE1|PHASE2 — 310 events, n=131 ROMULUS · PHASE1|PHASE2 — 232 events, n=142 A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, an · PHASE1|PHASE2 — 230 events, n=115 A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cy · PHASE1|PHASE2 — 216 events, n=82 A Study of Obinutuzumab, Polatuzumab Vedotin, and Lenalidomide in Relapsed or Re · PHASE1|PHASE2 — 204 events, n=113 GO29365 (Pola+BR / Pola+BG) · Phase 1b/2 — 149 events, n=38 Polatuzumab Vedotin, Rituximab, Ifosfamide, Carboplatin, and Etoposide (PolaR-IC · PHASE2 — 148 events, n=41 Pola-R-ICE (NCT04665765) · Phase 2 — 143 events, n=35 ROMULUS (Pola+anti-CD20 arms) · Phase 1/2 — 142 events, n=20 POLARGO · PHASE3 — 133 events, n=286 Pola + Venetoclax + G/R (NCT02611323) · Phase 1b/2 — 123 events, n=41 Pola-R-GemOx (NCT04182204) · Phase 3 — 113 events, n=143 GO40516 (Mosun + CHP-Pola) · Phase 1/2 — 111 events, n=38 A Study Evaluating Safety and Efficacy of Obinutuzumab, Polatuzumab Vedotin (Pol · PHASE1|PHASE2 — 103 events, n=34 Pola + Lenalidomide + G/R (NCT02600897) · Phase 1b/2 — 99 events, n=40 SUNMO · PHASE3 — 93 events, n=135 Obin + Pola + Venetoclax (NCT02729896) · Phase 1b/2 — 92 events, n=10 Pola + R-CHP/G-CHP 1L DLBCL (NCT01992653) · Phase 1b/2 — 89 events, n=40 SUNMO (Mosun-Pola) · Phase 3 — 86 events, n=135 A Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combinatio · PHASE3 — 83 events, n=27 Pola+BR Japan bridging (NCT04236141) · Phase 3 — 66 events, n=28 Mosun+Obin+Pola (NCT05169658) · Phase 2 — 64 events, n=42 GO29365 (Pola+BR / Pola+BG) · Phase 1b/2 — 63 events, n=39 Pola + R-CHP/G-CHP 1L DLBCL (NCT01992653) · Phase 1b/2 — 56 events, n=17 Pola + Lenalidomide + G/R (NCT02600897) · Phase 1b/2 — 53 events, n=10 Pola + Venetoclax + G/R (NCT02611323) · Phase 1b/2 — 43 events, n=40 GO29365 (Pola+BR / Pola+BG) · Phase 1b/2 — 42 events, n=20 ROMULUS (Pola+anti-CD20 arms) · Phase 1/2 — 41 events, n=40 GO29365 (Pola+BR / Pola+BG) · Phase 1b/2 — 40 events, n=20 Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treat · PHASE2 — 36 events, n=42 GO29365 (Pola+BR / Pola+BG) · Phase 1b/2 — 33 events, n=106 POLARIX (Pola-R-CHP) NCT03274492 · Phase 3 — 31 events, n=435 Pola + Lenalidomide + G/R (NCT02600897) · Phase 1b/2 — 25 events, n=39 Unattributed cohort — 24 events, n=435 GO40516 (Mosun + CHP-Pola) · Phase 1/2 — 24 events, n=22 ROMULUS (Pola+anti-CD20 arms) · Phase 1/2 — 23 events, n=40 Unattributed cohort — 18 events, n=173 GO29365 (Pola-BR randomized) NCT02257567 · Phase 1b/2 — 17 events, n=45 GO29365 pooled R/R DLBCL (Pola+BR or Pola+obinutuzumab) NCT02257567 · Phase 1b/2 — 15 events, n=173 POLARIX (GO39942) · Approved — 13 events, n=435 GO29365 (Pola-BR) NCT02257567 - laboratory abnormalities · Phase 1b/2 — 12 events, n=45 Obin + Pola + Venetoclax (NCT02729896) · Phase 1b/2 — 9 events, n=21 GO29365 (expanded safety population) · Approved — 8 events, n=173 GO29365 · Approved — 7 events, n=45 GO29365 pooled R/R DLBCL (Pola+BR or Pola+obinutuzumab) NCT02257567 · Phase 1b/2 — 1 event, n=173 GO29365 pooled R/R DLBCL (Pola+BR or Pola+obinutuzumab) NCT02257567 · Phase 1b/2 — 1 event, n=173 Unattributed cohort — 1 event, n=45 GO29365 (Pola-BR randomized) NCT02257567 · Phase 1b/2 — 1 event, n=45 GO40516 (Mosun + CHP-Pola) · Phase 1/2 — 1 event, n=8 Pola + Venetoclax + G/R (NCT02611323) · Phase 1b/2 — 1 event, n=7 Pola + R-CHP/G-CHP 1L DLBCL (NCT01992653) · Phase 1b/2 — 1 event, n=6 Pola-R-ICE (NCT04665765) · Phase 2 — 1 event, n=6 GO29365 (Pola+BR / Pola+BG) · Phase 1b/2 — 1 event, n=6 Pola-R-GDP (NCT05498220) · Phase 2 — 1 event, n=5 Pola+Ven+R (NCT04659044) · Phase 2 — 1 event, n=3 Pola + Lenalidomide + G/R (NCT02600897) · Phase 1b/2 — 1 event, n=3 A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obin PHASE1|PHASE2 real-world n=327 CTCAE NR (ClinicalTrials.gov C
360 adverse-event terms · 21 systems · expand a system below
UPPER RESPIRATORY TRACT INFECTION
9.48% non-serious
URINARY TRACT INFECTION
5.81% non-serious
HERPES ZOSTER
5.2% non-serious
BRONCHITIS
2.75% non-serious
ORAL HERPES
2.75% non-serious
NASOPHARYNGITIS
2.45% non-serious
SINUSITIS
2.45% non-serious
ORAL CANDIDIASIS
1.83% non-serious
HERPES VIRUS INFECTION
1.22% non-serious
CANDIDA INFECTION
0.92% non-serious
INFECTION
0.92% non-serious
NEUTROPENIC SEPSIS
0.92% serious
RESPIRATORY TRACT INFECTION
0.92% serious
CELLULITIS
0.92% non-serious
CLOSTRIDIUM DIFFICILE INFECTION
0.61% non-serious
CYTOMEGALOVIRUS INFECTION
0.61% non-serious
LOWER RESPIRATORY TRACT INFECTION
0.61% non-serious
RHINOVIRUS INFECTION
0.61% serious
ABDOMINAL ABSCESS
0.31% serious
ABDOMINAL INFECTION
0.31% serious
ARTHRITIS BACTERIAL
0.31% serious
BACTERIAL INFECTION
0.31% serious
CLOSTRIDIUM DIFFICILE COLITIS
0.31% serious
COVID-19 PNEUMONIA
0.31% serious
CYTOMEGALOVIRUS COLITIS
0.31% serious
CYTOMEGALOVIRUS ENTERITIS
0.31% serious
CYTOMEGALOVIRUS VIRAEMIA
0.31% non-serious
DEVICE RELATED INFECTION
0.31% serious
DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION
0.31% serious
DIVERTICULITIS
0.31% serious
EAR INFECTION
0.31% non-serious
ENTEROCOLITIS VIRAL
0.31% serious
ESCHERICHIA BACTERAEMIA
0.31% serious
ESCHERICHIA URINARY TRACT INFECTION
0.31% non-serious
GASTROENTERITIS
0.31% serious
OESOPHAGEAL CANDIDIASIS
0.31% serious
ORAL INFECTION
0.31% serious
PLEURAL INFECTION BACTERIAL
0.31% serious
PNEUMONIA BACTERIAL
0.31% serious
PNEUMONIA FUNGAL
0.31% serious
POST PROCEDURAL INFECTION
0.31% serious
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
0.31% serious
RESPIRATORY SYNCYTIAL VIRUS INFECTION
0.31% serious
RESPIRATORY TRACT INFECTION VIRAL
0.31% serious
SKIN INFECTION
0.31% non-serious
VASCULAR ACCESS SITE CELLULITIS
0.31% serious
CEREBRAL TOXOPLASMOSIS
0.31% serious
CLOSTRIDIAL SEPSIS
0.31% serious
GASTROINTESTINAL BACTERIAL INFECTION
0.31% serious
HUMAN ANAPLASMOSIS
0.31% serious
INFECTED LYMPHOCELE
0.31% serious
LARGE INTESTINE INFECTION
0.31% serious
MENINGOENCEPHALITIS HERPETIC
0.31% serious
PNEUMOCYSTIS JIROVECII PNEUMONIA
0.31% serious
PNEUMONIA CYTOMEGALOVIRAL
0.31% serious
PNEUMONIA PNEUMOCOCCAL
0.31% serious
PNEUMONIA VIRAL
0.31% serious
FOLLICULITIS
0.31% non-serious
RASH PUSTULAR
0.31% non-serious
VASCULAR ACCESS SITE INFECTION
0.31% non-serious
EYE PRURITUS
0.92% non-serious
VISION BLURRED
0.92% non-serious
CYTOMEGALOVIRUS CHORIORETINITIS
0.31% serious
OCULAR HYPERAEMIA
0.31% non-serious
EYE DISCHARGE
0.31% non-serious
02 Construct
Molecular anatomy Linker structure C28H40N6O7
[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] copy
Payload structure C39H67N5O7
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 copy
03 Antibody
Antibody & Fc engineering Antibody
MCDS4501A (polatuzumab)
Fc modifications
None inferred
Glycoengineering
Standard inferred
Effector silencing
None inferred
C1q binding
Retained inferred
Epitope / domain
CD79b extracellular Ig-like domain
Linker
MC-vc-PAB (vedotin)
Attachment
Cysteine (interchain)
Conjugation
Conventional interchain Cys
DAR homogeneity
Heterogeneous
Cleavage trigger
Cathepsin B (Val-Cit)
Release control
Conditional
Hydrophilicity mask
None inferred
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
Mechanism
Tubulin inhibitor
Released catabolite
Unconjugated MMAE
Mechanistic subtype
Tubulin-auristatin
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 (
07 Pharmacology
Clinical pharmacokinetics By analyte · FDA label §12.3 + Drugs@FDA clinical-pharmacology reviews
Intact ADC Free payload Cmax 688 ng/mL +2
3.19 ng/mL +2
AUC 2040 day*ng/mL +2
31.0 day*ng/mL +2
t½ 12.2 days
3.74 days
CL 0.9 L/day
— Vd 3.15 L
—
hover a value for dose / population / source · “+N” marks additional reported values
08 Ocular & expression
Ocular profile & eye-tissue target expression Target profile → Grading scale
CTCAE v4.03 locator?
Target expression in eye tissues (HCA detection · HPA bulk)
Cross-trial comparability · source-verified
Ascertainment: Symptom-driven reporting Scale: CTCAE v4 Denominator: 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
n=173 · GO29365 (expanded safety population)
n=10 · Obin + Pola + Venetoclax
n=20 · ROMULUS (Pola+anti-CD20 arms)
n=34 · A Study Evaluating Safety and Efficacy of Obinutuzumab, Polatuzumab Vedotin (Pol
n=40 · ROMULUS (Pola+anti-CD20 arms)
n=17 · Pola + R-CHP/G-CHP 1L DLBCL
n=38 · GO40516 (Mosun + CHP-Pola)
n=40 · Pola + Lenalidomide + G/R
n=20 · GO29365 (Pola+BR / Pola+BG)
n=20 · GO29365 (Pola+BR / Pola+BG)
n=22 · GO40516 (Mosun + CHP-Pola)
n=115 · A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, an
n=113 · A Study of Obinutuzumab, Polatuzumab Vedotin, and Lenalidomide in Relapsed or Re
n=40 · Pola + Venetoclax + G/R
n=41 · Polatuzumab Vedotin, Rituximab, Ifosfamide, Carboplatin, and Etoposide (PolaR-IC
n=41 · Pola + Venetoclax + G/R
n=131 · A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relap
n=82 · A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cy
n=327 · A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obin
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 09 Identity & registry
Identifiers, registry & notes ADC id
polatuzumab-vedotin
Approval status
FDA-approved
Primary source
POLIVY DailyMed label (Mar 2026); imputed from >=10% threshold
Aliases & development codes
Polivy; DCDS4501A
Notes
5% imputed; CD79B absent from cornea/conjunctiva