Antibody–Drug Conjugates in Oncology

A comprehensive landscape of ADC clinical trials and approved therapies across the United States and European Union, spanning all development phases, target antigens, and tumor indications.
Data current as of February 2026
Sources: ClinicalTrials.gov, FDA, EMA
ADC Clinical
Landscape Overview

Pipeline Distribution by Development Phase

Figure 1
Clinical Development Overview

a  Trials by Development Phase

b  Top Tumour Indications

c  Lead Sponsors

Figure 2
Molecular Characteristics

a  Target Antigen Frequency

b  Cytotoxic Payload Classes

Table 1
Key Regulatory & Clinical Events, 2025–2026
Approvals & Positive Readouts
Jan 2025
Datopotamab deruxtecan (Datroway) — FDA
Approved for HR+/HER2− metastatic breast cancer after prior endocrine therapy and chemotherapy (TROPION-Breast01)
Jan 2025
Trastuzumab deruxtecan — FDA (label expansion)
Full approval for HER2-low/ultralow mBC based on DESTINY-Breast06
Mar 2025
Tisotumab vedotin (Tivdak) — EMA Approval
EC granted marketing authorisation for recurrent/metastatic cervical cancer in Europe (innovaTV 301)
May 2025
Telisotuzumab vedotin (Emrelis) — FDA
Accelerated approval for c-Met-overexpressing non-squamous NSCLC (LUMINOSITY)
Jun 2025
Datopotamab deruxtecan — FDA (2nd indication)
Accelerated approval in EGFR-mutant NSCLC after TKI progression (TROPION-Lung05)
Jul 2025
Polatuzumab vedotin (Polivy) — Phase 3 OS+
POLARGO trial showed significant OS benefit in transplant-ineligible R/R DLBCL
Oct 2025
Belantamab mafodotin (Blenrep) — FDA re-approval
Re-approved for R/R multiple myeloma with bortezomib + dex (DREAMM-7/8 data)
Nov 2025
Enfortumab vedotin + pembrolizumab — FDA
Approved for muscle-invasive bladder cancer, perioperative setting (EV-303/KEYNOTE-905)
2025
Enhertu + pertuzumab — DESTINY-Breast09 positive
44% reduction in PD/death vs THP in 1L HER2+ mBC; regulatory submission expected
2025
ASCENT-03 & ASCENT-04 — positive
Sacituzumab govitecan ± pembrolizumab in 1L mTNBC met primary endpoints
Dec 2025
LOTIS-7 — updated data
Loncastuximab tesirine + glofitamab: 89.8% ORR, 77.6% CR in R/R DLBCL
Setbacks, Withdrawals & Pipeline Updates
May 2025
HER3-DXd BLA voluntarily withdrawn
Patritumab deruxtecan withdrawn for EGFR-mutant NSCLC; HERTHENA-Lung02 did not reach significant OS. Program continues in breast cancer.
2025
Tusamitamab ravtansine — discontinued
Sanofi terminated CEACAM5-targeting ADC after Phase 3 CARMEN-LC03 failure in 2L NSCLC
Dec 2025
I-DXd Phase 3 partial clinical hold
IDeate-Lung02 in ES-SCLC paused due to higher-than-expected Grade 5 ILD events; safety under review
2025
ASCENT-07 — missed primary endpoint
Sacituzumab govitecan in 1L HR+/HER2− mBC did not meet PFS vs chemotherapy
2023
Mersana XMT-1592 (NaPi2b) — discontinued
UPLIFT trial in platinum-resistant ovarian cancer failed endpoints
Aug 2025
I-DXd — Breakthrough Therapy Designation
FDA granted BTD for pretreated ES-SCLC based on IDeate-Lung01 Phase 2 data (ORR 53%)
Aug 2025
HER3-DXd — Phase 3 initiated (breast)
HERTHENA-Breast04 opened in HR+/HER2− mBC post CDK4/6i; pivotal study
2025
T-DXd BTD for early breast cancer
Granted based on DESTINY-Breast05 iDFS data vs T-DM1 in post-neoadjuvant HER2+ BC
Late 2025
Datroway — EMA Approval (EU)
EC marketing authorisation for HR+/HER2− metastatic breast cancer
Dec 2025
Padcev MIBC — EMA variation validated
Type II variation application accepted for enfortumab vedotin + pembrolizumab in MIBC
Table 2
ADC Clinical Trial Database
Phase
Region

All Entries

Drug ↕ Target ↕ Payload / Linker ↕ Sponsor ↕ Tumour Indication ↕ Phase ↕ Trial / NCT Region ↕ Status ↕
Antibody–Drug Conjugates in Oncology — US & EU Landscape Dashboard
Data compiled from ClinicalTrials.gov, US Food & Drug Administration (FDA), European Medicines Agency (EMA), and company press releases. This dashboard is for informational and research purposes only; it does not constitute medical advice. ADC = antibody–drug conjugate; BC = breast cancer; DLBCL = diffuse large B-cell lymphoma; ES-SCLC = extensive-stage small-cell lung cancer; GEJ = gastro-oesophageal junction; ILD = interstitial lung disease; mBC = metastatic breast cancer; MIBC = muscle-invasive bladder cancer; NSCLC = non-small-cell lung cancer; OS = overall survival; PFS = progression-free survival; R/R = relapsed/refractory; TNBC = triple-negative breast cancer.