Table 4 Characteristics of clinical trials used for the approval of the ADC including design, indication, line of treatment, endpoint and efficacy data. The last column displayed information, when available, about the clinical activity of the previous standard of care in the indication of approval

Belantamab mafodotin

DREAMM-2. NCT03525678

MM > 3 lines, including anti-CD38, proteasome inhibitor and one immunomodulator

Phase 2. Open label trial of BM monotherapy with two cohorts: BM at 2.5 mg/kg and 3.4 mg/kg

ORR

ORR 31% at 2.5 mg/kg

DOR > 6 months 73%

Brentuximab vedotin (adults)

ECHELON-1

LHc III or IV treatment-naive

Phase 3, randomized 1:1 A + AVD versus ABVD

Modified PFS

mPFS not reached at approval, with HR 0.77 y p 0.035

NCTOl712490

Enfortumab vedotin

EV-301

Advanced urothelioma that has received anti-PD-(L)1 and platinum

Phase 3 randomized 1:1 EV versus TPC

OS

OS 12.88 versus 8.97 m. HR 0.70

NCT03474107

PFS 5.55 versus 3.71 m. HR 0.62

Gemtuzumab ozogamicin monotherapy (adults)

AML-19

AML CD33 + treatment-naive. Elderly, ECOG 2

Phase 3, randomized, M versus BSC

OS

OS 4.9 versus 3.6 m

NCT00091234

HR 0.69

Gemtuzumab ozogamicin combination (adults)

ALFA-0701 NCT00927498

AMLCD33 + treatment-naive

Phase 3, randomized 1:1 a DA-M versus DA

EFS

2-y EFS: 17.1% versus 40.8%

HR 0.58

lnotuzumab ozogamicin

INO-VATE ALL NCT01564784

Relapsed or refractory ALL CD22 + 

Phase 3, randomized 1:1 de 10 versus TPC

CR and OS

CR 80.7% versus 29.4%

DOR 4.6 versus 3.1 m

PFS 5 versus 1.8 m

OS 7.7 versus 6.7 m

Loncastuximab tesirine

LOTIS-2. NCT03589469

DLBCL or HGBL. > 1 previous line

Single-arm phase 2 LT monotherapy

ORR

ORR48.3%

CR 24.1%

DOR 10.3 months

Polatuzumab vedotin

POLARIX trial. (NCT03274492)

With rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP)for adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of 2 or greater

PFS

PFS: 76.7% vs. 70.2% at 2 years; HR: 0. 73

Sacituzumab govitecan

TROPiCS-02.NCT03901339

mLBC. Endocrine therapy, CDK-i and > 2 previous CT

SG versus TPC 1:1

PFS

(HR 0.66)

ORR 21% versus 14%

Sacituzumab govitecan

ASCENT. NCT02574455

mTNBC

Phase 3. Randomized

PFS in the CNS disease-free population

PFS 5.6 versus 1.7 m

 > 2 previous lines

SG versus TPC 1:1

OS 12.1 versus 6.7 m

ORR 35% versus 5%

Tisotumab vedotin

lnnovaTV 204

Metastatic cervix uterii. 1–2 previous line including platinum agent

Single-arm phase 2. TV monotherapy

ORR and DOR

ORR 24%

NCT03438396

DOR 8.3 months

Trastuzumab deruxtecan

DESTINY-Breast03

CMm HER2 + . Previous taxane and trastuzumab, no T-DMl

Phase 3, randomized. T-DXd versus T-DMl 1:1

PFS

PFS 28.8 versus 6.8

NCT03529110

OS NR, HR 0.64

ORR 79.7 versus 34.2%

Trastuzumab deruxtecan

DESTINY-Breast04

CMm HER2-low. HR + and HR-

Phase 3, randomized. T-DXd versus TPC 2:1

PFS in HR + population

PFS 10.1 versus5.4 m

NCT03734029

1–2 previous CT

05 23.9 versus 17.5 m

ORR 52.6% versus 16.3%

Trastuzumab deruxtecan

DESTI NY-GastricOl

Gastric o GEJ HER2 + . Previous trastuzumab, FluorP and platinum agent and > 2 L

Phase 2. Randomized with T-DXd 6.4 mg/Kg versus TPC

ORR

ORR 40.5% versus 11.3%

NCT03329690

OS key secondary endpoint

OS 12.5 versus 8.4 m

HR 0.59

Trastuzumab emtansine

EMILIA NCT00829166

MBC HER2 + , previous line with a taxane and trastuzumab

Phase 3, randomized 1:1 de T-DMl versus lapatinib-capecitabine

PFS y 05

PFS 9.6 m versus 6.4 m

OS 30.9 versus 25.1 m

Trastuzumab emtansine

KATHERINE NCT01772472

HER2+ eBC with residual disease after NACT with taxane and trastuzumab

Phase 3, randomized 1:1 T-DMl versus trastuzumab

iDFS

3-y iDFS 88.3% versus 77%, HR 0.50