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Telisotuzumab vedotin FDA-approved Emrelis; Teliso-V; ABBV-399
Target family
Receptor tyrosine kinase
RP2D dose
1.9 mg/kg Q2W RP2D
01 Multi-organ toxicity
Fingerprint & organ drill-down Any-grade Grade 3+
Ocular
25%
Hepatic
41%
Neutrop.
10%
Thrombo.
14%
Anemia
35%
GI
15%
ILD
10%
Neuro.
51%
Also reported Other · 16 · 4 systems
4 adverse-event terms
Ocular Toxicity Target expression Compare
sagittal schematic · Reversible
↳ Tissues shaded by reported adverse-event rate.
Reported ocular events
Ocular surface disorders 25%
Per-trial detail
Adverse events by trial Lung-MAP S1400K (SWOG, NCT03574753) · PHASE2 — 40 events, n=23 NCT02099058 (teliso-V + erlotinib, phase Ib) · PHASE1 — 38 events, n=42 NCT02099058 (teliso-V + nivolumab, phase Ib) · PHASE1 — 33 events, n=37 Lung-MAP S1400K (SWOG, NCT03574753) · PHASE2 — 33 events, n=23 LUMINOSITY (NCT03539536) · PHASE2 — 32 events, n=168 NCT02099058 (M14-237 first-in-human) · PHASE1 — 28 events, n=28 NCT02099058 (M14-237 first-in-human) · PHASE1 — 28 events, n=24 NCT05513703 (teliso-V NSCLC, terminated) · PHASE2 — 28 events, n=9 Unattributed cohort — 21 events, n=168 LUMINOSITY (NCT03539536) · Approved — 17 events, n=168 Lung-MAP S1400K (SWOG, NCT03574753) · PHASE2 — 14 events, n=23 NCT03311477 (Japanese phase 1) · PHASE1 — 13 events, n=9 LUMINOSITY (NCT03539536) · PHASE2 — 11 events, n=84 NCT05513703 (teliso-V NSCLC, terminated) · PHASE2 — 8 events, n=9 Lung-MAP S1400K (SWOG, NCT03574753) · PHASE2 — 6 events, n=23 Lung-MAP S1400K (SWOG, NCT03574753) · PHASE2 — 6 events, n=23 Lung-MAP S1400K (SWOG, NCT03574753) · PHASE2 — 5 events, n=23 NCT05513703 (teliso-V NSCLC, terminated) · PHASE2 — 5 events, n=9 LUMINOSITY (NCT03539536) · PHASE2 — 3 events, n=45 LUMINOSITY (NCT03539536) · PHASE2 — 2 events, n=168 Lung-MAP S1400K (SWOG, NCT03574753) · PHASE2 — 2 events, n=23 Lung-MAP S1400K (SWOG, NCT03574753) · PHASE2 — 2 events, n=23 Lung-MAP S1400K (SWOG, NCT03574753) · PHASE2 — 2 events, n=23 NCT05513703 (teliso-V NSCLC, terminated) · PHASE2 — 2 events, n=9 Lung-MAP S1400K (SWOG, NCT03574753) · PHASE2 — 1 event, n=23 Lung-MAP S1400K (SWOG, NCT03574753) · PHASE2 — 1 event, n=23 Lung-MAP S1400K (SWOG, NCT03574753) · PHASE2 — 1 event, n=23 Lung-MAP S1400K (SWOG, NCT03574753) · PHASE2 — 1 event, n=23 Lung-MAP S1400K (SWOG, NCT03574753) · PHASE2 — 1 event, n=23 NCT05513703 (teliso-V NSCLC, terminated) · PHASE2 — 1 event, n=9 NCT05513703 (teliso-V NSCLC, terminated) · PHASE2 — 1 event, n=9 Lung-MAP S1400K (SWOG, NCT03574753) PHASE2 not specified not specified n=23 B
CT.gov NCT03574753 posted results (other AE (>=0%)) NCT03574753
40 adverse-event terms · 14 systems · expand a system below
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
ABT-700 (telisotuzumab)
Epitope / domain
Unique epitope outside the SEMA domain of c-Met
Species cross-reactivity
Binds human and cynomolgus c-Met; no detectable binding to mouse c-Met
Linker
MC-vc-PAB (vedotin)
Attachment
Cysteine (interchain)
Conjugation
Conventional interchain Cys
DAR homogeneity
Heterogeneous
Cleavage trigger
Cathepsin B (Val-Cit)
Release control
Conditional
Cell line
Chinese hamster ovary
Stability note
Mean harmonic t½ 2–4 d for ADC and total antibody (Strickler JCO 2018 Ph1 N=48); within vc-MMAE conventional Cys range
Mechanism
Tubulin inhibitor
Released catabolite
Unconjugated MMAE (monomethyl auristatin E)
Mechanistic subtype
Tubulin-auristatin
Plasma protein binding (%)
68 %
Hydrophobicity · logD₇.₄
hydrophilic −2 +2.7 +4 lipophilic
Bioactivity note
ADCdb reports clinical efficacy only (no biochemical IC50/binding for the ADC): ORR ~30.55% in efficacy-evaluable advanced NSCLC combination cohorts; highest observed ORR 71.70% (plus lenalidomide) in a multiple myeloma trial. No payload IC50 or ADC binding-affinity value reporte
07 Pharmacology
Clinical pharmacokinetics By analyte · FDA label §12.3 + Drugs@FDA clinical-pharmacology reviews
Intact ADC Total antibody Free payload Cmax 29 (43% CV) µg/mL
72.8 (47% CV) µg/mL +1
2.2 (53% CV) ng/mL
AUC 2,130 (55% CV) µg·h/mL
7,710 (46% CV) µg·h/mL +1
405 (64% CV) ng·h/mL
Tmax end of infusion (~0.5) h
— ~5 days
t½ ~3 days
3.68 (±1.12) days +1
~4 days
CL 1.3 (31.5% CV) L/day +1
— 76 (52.1% CV) L/day +1
Vd 3.4 (16.5% CV) L +1
— 96.0 L
hover a value for dose / population / source · “+N” marks additional reported values
08 Ocular & expression
Ocular profile & eye-tissue target expression Target profile → 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 · keratopathy (any-grade) by cohort
1.9 mg/kg
Q2W (IV over 30 min)
n=168 · LUMINOSITY
n=9 · NCT03311477 (Japanese phase 1)
n=9 · NCT05513703 (teliso-V NSCLC, terminated)
not specified
not specified
n=23 · Lung-MAP S1400K (SWOG, NCT03574753)
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
telisotuzumab-vedotin
Approval status
FDA-approved
Primary source
EMRELIS PI Section 5.3; LUMINOSITY Camidge JCO 2024
Aliases & development codes
Emrelis; Teliso-V; ABBV-399
Notes
Visual-dominant (blurred 15%) pattern; possible RPE involvement (MET 60% RPE)