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Anetumab ravtansine Discontinued BAY 94-9343
Indication
MSLN+ mesothelioma
Target family
GPI-anchored
RP2D dose
6.5 mg/kg Q3W RP2D
01 Multi-organ toxicity
Fingerprint & organ drill-down Any-grade Grade 3+
Ocular
37%
Hepatic
29%
Neutrop.
-
Thrombo.
21%
Anemia
16%
GI
58%
ILD
-
Neuro.
37%
Also reported Other · 372 · 18 systems
39 adverse-event terms
Ocular Toxicity Target expression Compare
sagittal schematic · Reversible
↳ Tissues shaded by reported adverse-event rate.
Off-target signature
37% corneal toxicity, yet the Mesothelin target is detected in only 13.34% of central cornea - toxicity is not explained by target expression.
Surface subtype
Corneal (off-target)
Reported ocular events
Eye disorders - Other, specify 29.03%
Lacrimation decreased 3.68%
Visual acuity reduced 3.68%
Conjunctival haemorrhage 0.61%
Lacrimation disorder 0.61%
Retinal vascular disorder 0.61%
Conjunctival hyperaemia 0.61%
Lacrimation increased 0.61%
Keratitis/keratopathy (Grade 4) -
Per-trial detail
Adverse events by trial Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothe · PHASE2 — 358 events, n=163 ARCS-M (Phase II 2nd-line MPM) · Phase 2 — 293 events, n=163 Pembrolizumab With or Without Anetumab Ravtansine in Treating Patients With Meso · PHASE1|PHASE2 — 167 events, n=31 ARCS-M (Phase II 2nd-line MPM) · Phase 2 — 158 events, n=72 Phase 1/2 pembrolizumab +/- anetumab (pleural mesothelioma) · Phase 1/2 — 118 events, n=18 Phase II anetumab pretreated pancreatic · Phase 2 — 118 events, n=18 Phase 1/2 pembrolizumab +/- anetumab (pleural mesothelioma) · Phase 1/2 — 103 events, n=17 Phase II Anetumab Ravtansine in Pre-treated Mesothelin-expressing Pancreatic Can · PHASE2 — 102 events, n=18 Rollover study (anetumab mono or + gemcitabine) · Phase 2 — 59 events, n=9 ARCS-M (Phase II 2nd-line MPM) · Phase 2 — 56 events, n=163 Phase Ib anetumab ravtansine + pegylated liposomal doxorubicin (ovarian) · Phase 1b — 31 events, n=65 ARCS-M (Phase II 2nd-line MPM) · Phase 2 — 30 events, n=72 Phase 1/2 pembrolizumab +/- anetumab (pleural mesothelioma) · Phase 1/2 — 26 events, n=13 Hassan FIH Phase I dose-escalation/expansion (BAY94-9343) · Phase 1 — 22 events, n=38 Hassan FIH Phase I dose-escalation/expansion (BAY94-9343) · Phase 1 — 22 events, n=36 Hassan FIH Phase I dose-escalation/expansion (BAY94-9343) · Phase 1 — 22 events, n=35 Phase II anetumab pretreated pancreatic · Phase 2 — 19 events, n=18 Hassan FIH Phase I dose-escalation/expansion (BAY94-9343) · Phase 1 — 17 events, n=38 Randomized Phase II bevacizumab + weekly anetumab (ARB) vs weekly paclitaxel (PB), ovarian · Phase 2 — 15 events, n=28 Anetumab ravtansine FIH Phase 1 (NCT01439152) · Phase 1 — 12 events, n=38 Hassan FIH Phase I dose-escalation/expansion (BAY94-9343) · Phase 1 — 11 events, n=36 Anetumab lung adenocarcinoma (terminated, safety run-in) · Phase 2 — 10 events, n=2 Unattributed cohort — 9 events Hassan FIH Phase I dose-escalation/expansion (BAY94-9343) · Phase 1 — 8 events, n=35 Randomized Phase II bevacizumab + weekly anetumab (ARB) vs weekly paclitaxel (PB), ovarian · Phase 2 — 8 events, n=29 Rollover study (anetumab mono or + gemcitabine) · Phase 2 — 4 events, n=9 Hassan FIH Phase I dose-escalation/expansion (BAY94-9343) · Phase 1 — 2 events, n=38 Hassan FIH Phase I dose-escalation/expansion (BAY94-9343) · Phase 1 — 2 events, n=38 Hassan FIH Phase I dose-escalation/expansion (BAY94-9343) · Phase 1 — 2 events, n=36 Hassan FIH Phase I dose-escalation/expansion (BAY94-9343) · Phase 1 — 2 events, n=36 Hassan FIH Phase I dose-escalation/expansion (BAY94-9343) · Phase 1 — 2 events, n=35 Hassan FIH Phase I dose-escalation/expansion (BAY94-9343) · Phase 1 — 2 events, n=35 Randomized Phase II bevacizumab + weekly anetumab (ARB) vs weekly paclitaxel (PB), ovarian · Phase 2 — 2 events, n=28 Phase 1/2 pembrolizumab +/- anetumab (pleural mesothelioma) · Phase 1/2 — 2 events, n=18 ARCS-M (Phase II 2nd-line MPM) · Phase 2 — 1 event, n=163 ARCS-M (Phase II 2nd-line MPM) · Phase 2 — 1 event, n=72 Phase 1/2 pembrolizumab +/- anetumab (pleural mesothelioma) · Phase 1/2 — 1 event, n=18 Phase II anetumab pretreated pancreatic · Phase 2 — 1 event, n=18 Phase 1/2 pembrolizumab +/- anetumab (pleural mesothelioma) · Phase 1/2 — 1 event, n=17 Phase 1/2 pembrolizumab +/- anetumab (pleural mesothelioma) · Phase 1/2 — 1 event, n=17 Phase 1/2 pembrolizumab +/- anetumab (pleural mesothelioma) · Phase 1/2 — 1 event, n=13 Rollover study (anetumab mono or + gemcitabine) · Phase 2 — 1 event, n=9 A Clinical Study of Anetumab Ravtansine in Adults With Solid Tumors Who Have Bee · PHASE2 — 1 event, n=9 Anetumab lung adenocarcinoma (terminated, safety run-in) · Phase 2 — 1 event, n=2 Anetumab lung adenocarcinoma (terminated, safety run-in) · Phase 2 — 1 event, n=2 Unattributed cohort — 1 event Unattributed cohort — 1 event Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothe PHASE2 real-world n=163 CTCAE NR (ClinicalTrials.gov C
358 adverse-event terms · 21 systems · expand a system below
Urinary tract infection
4.29% non-serious
Upper respiratory tract infection
3.07% non-serious
Oral candidiasis
3.07% non-serious
Bronchitis
2.45% non-serious
Cellulitis
1.84% non-serious
Oral fungal infection
1.23% non-serious
Pneumonia
1.23% non-serious
Respiratory tract infection
1.23% non-serious
Lung infection
1.23% non-serious
Nasopharyngitis
1.23% non-serious
Folliculitis
0.61% non-serious
Infectious pleural effusion
0.61% non-serious
Lip infection
0.61% non-serious
Otitis media
0.61% non-serious
Penile infection
0.61% non-serious
Sinusitis
0.61% non-serious
Bronchitis bacterial
0.61% non-serious
Candida infection
0.61% non-serious
Enterocolitis infectious
0.61% serious
Febrile infection
0.61% non-serious
Gastroenteritis viral
0.61% non-serious
Herpes zoster
0.61% non-serious
Mucosal infection
0.61% non-serious
Peripheral nerve infection
0.61% non-serious
Post procedural sepsis
0.61% serious
Pyelonephritis
0.61% non-serious
Rectal abscess
0.61% non-serious
Tonsillitis
0.61% non-serious
Vaginal infection
0.61% non-serious
Arthritis bacterial
0% serious
Ear infection
0% non-serious
Gastrointestinal infection
0% non-serious
Genital candidiasis
0% non-serious
Lower respiratory tract infection
0% non-serious
Tongue fungal infection
0% non-serious
Vascular device infection
0% serious
Corneal disorder
39.88% non-serious
Lacrimation decreased
3.68% non-serious
Visual acuity reduced
3.68% non-serious
Blepharitis
3.07% non-serious
Vision blurred
3.07% non-serious
Conjunctivitis
1.84% non-serious
Eye infection
1.84% non-serious
Eye irritation
1.23% non-serious
Visual impairment
1.23% non-serious
Conjunctival haemorrhage
0.61% non-serious
Corneal erosion
0.61% non-serious
Lacrimation disorder
0.61% non-serious
Retinal vascular disorder
0.61% non-serious
Vitreous floaters
0.61% non-serious
Cataract cortical
0.61% non-serious
Cataract nuclear
0.61% non-serious
Conjunctival hyperaemia
0.61% non-serious
Eye discharge
0.61% non-serious
Eye pruritus
0.61% non-serious
Eyelid infection
0.61% non-serious
Lacrimation increased
0.61% non-serious
Ocular discomfort
0.61% non-serious
Photophobia
0.61% non-serious
Pinguecula
0.61% non-serious
Retinal haemorrhage
0.61% non-serious
Retinal tear
0.61% non-serious
Ocular hypertension
0% non-serious
02 Construct
Molecular anatomy Linker structure C13H14N2O4S2
[H]c1nc(SSC([H])([H])C([H])([H])C([H])([H])C(=O)ON2C(=O)C([H])([H])C([H])([H])C2=O)c([H])c([H])c1[H] copy
Payload structure C38H54ClN3O10S
C[C@@H]1[C@@H]2C[C@]([C@@H](/C=C/C=C(/CC3=CC(=C(C(=C3)OC)Cl)N(C(=O)C[C@@H]([C@]4([C@H]1O4)C)OC(=O)[C@H](C)N(C)C(=O)CCC(C)(C)S)C)\C)OC)(NC(=O)O2)O copy
03 Antibody
Antibody & Fc engineering Fc modifications
None inferred
Glycoengineering
Standard inferred
Effector silencing
None inferred
C1q binding
Retained inferred
Dev code
BAY 86-1903 silent
Epitope / domain
Mesothelin Region I silent
Conjugation
Conventional Lys (SPDB)
DAR homogeneity
Heterogeneous
Cleavage trigger
GSH/reductive (disulfide)
Release control
Conditional
Hydrophilicity mask
None inferred
Stability note
Average t½ 5.5 d in Hassan JCO 2020 Ph1 N=148 mesothelin-positive solid tumors; dose-proportional PK 0.15–7.5 mg/kg
Mechanism
Tubulin inhibitor
Released catabolite
DM4 and S-methyl-DM4 (DM4-Me)
Mechanistic subtype
Tubulin-maytansinoid
Hydrophobicity · logD₇.₄
hydrophilic −2 +3 +4 lipophilic
Bioactivity note
ADCdb reports payload/ADC potency IC50 ranging from 1.0 nM (MIA PaCa-2) to 42.4 nM (NCI-ADR-RES) across cell lines; clinical objective response rates 9.6%-42.1% (mesothelin-expression dependent), median PFS 4.3-8.5 months in Phase 2. Source: ADCdb DRG0EPHMC.
08 Ocular & expression
Ocular profile & eye-tissue target expression Target profile → Surface subtype
Corneal (off-target)
Target expression in eye tissues (HCA detection · HPA bulk)
Cross-trial comparability · source-verified
Ascertainment: Partial / unspecified monitoring Scale: Unknown Denominator: RP2D ⚠ Not comparable: grading scale not documented
Dose & schedule → ocular toxicity · keratopathy (any-grade) by cohort
n=18 · Phase II anetumab pretreated pancreatic
6.5 mg/kg
Q3W (once every 3 weeks), IV
n=38 · Anetumab ravtansine FIH Phase 1
n=18 · Phase 1/2 pembrolizumab +/- anetumab (pleural mesothelioma)
n=13 · Phase 1/2 pembrolizumab +/- anetumab (pleural mesothelioma)
n=163 · ARCS-M (Phase II 2nd-line MPM)
n=72 · ARCS-M (Phase II 2nd-line MPM)
n=17 · Phase 1/2 pembrolizumab +/- anetumab (pleural mesothelioma)
n=163 · Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothe
n=18 · Phase II Anetumab Ravtansine in Pre-treated Mesothelin-expressing Pancreatic Can
n=31 · Pembrolizumab With or Without Anetumab Ravtansine in Treating Patients With Meso
n=9 · Rollover study (anetumab mono or + gemcitabine)
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
anetumab-ravtansine
Approval status
Discontinued
Primary source
Hassan JCO 2020 PMID 32213105 no such source
Aliases & development codes
BAY 94-9343
Notes
DM4 class; high conjunctival expression doesn't increase severity vs low-expression DM4 ADCs. V3.1: n_rp2d=148 retained (pooled Ph1 across cohorts; label/paper uses this denominator for OAE%). Light chain λ not explicitly verified — retained from literature. no such source