FDA and/or EMA-approved combinations of ADCs

CombinationApproval yearPatient populationPhasePrimary endpointComparator armPrimary endpoint results G3–4 AEs
Gemtuzumab ozogamicin + daunorubicin + cytarabine2017Untreated AML; R/R AMLIIIEFSDAEFS 40.8% vs. 17.1%13% vs. 9.2%
Gemtuzumab ozogamicin + induction CT and intensification CT2020Untreated AML pediatric patientIIIEFSInduction CT and intensification CTEFS 48% vs. 40.0%76% vs. 76%
Brentuximab vedotin + AVD2018Untreated HL IIIPFSABVDPFS 82.1% vs. 78.8%83% vs. 66%
Brentuximab vedotin + CHP2018Untreated PTCL/ sALCLIIIPFSCHOPPFS 57.1% vs. 44.4%66% vs. 65%
Brentuximab vedotin + AVEPC2022Pediatric untreated HLIIIEFSABVE-PCNR73.5% vs. 68.2
Polatuzumab vedotin + BR2019R/R DLBCLIb–IISafety, tolerability, CR rateBRCR 40.0% vs. 17.5%Anemia 28.2% vs. 17.9%, Neutropenia 46.2% vs. 33.3%
Polatuzumab vedotin + R-CHP2023Untreated DLBCL, NOS or HGBLIIIPFSR-CHOPPFS 76.7% vs. 70.2%60.7% vs. 69.8%
Enfortumab vedotin + Pembro2023Untreated la/mUCIIIPFS/OSGemcitabine + Cisplatin/CarboplatinPFS 12.5% vs. 6.3%
OS 31.5% vs. 16.1%
55.9% vs. 69.5%

FAD: Food and Drug Administration; EMA: European Medicines Agency; ADCs: antibody-drug conjugates; G3–4: grade 3–4; AEs: adverse events; R/R: relapsed or refractory; AML: acute myeloid leukemia; EFS: event-free survival; DA: daunorubicin and cytarabine; CT: chemotherapy; AVD: doxorubicin-vinblastine-dacarbazine; PFS: progression-free survival; ABVD: doxorubicin-bleomycin-vinblastine-dacarbazine; PTCL: peripheral T-cell lymphoma; sALCL: systemic anaplastic large-cell lymphoma; CHP: cyclophosphamide-doxorubicin-prednisone; CHOP: cyclophosphamide-doxorubicin-vincristine-prednisone; CR: complete response; HL: Hodgkin lymphoma; ABVE-PC: doxorubicin-bleomycin-vincristine-etoposide-prednisone-cyclophosphamide; NR: not reached; BR: bendamustine-rituximab; DLBCL: diffuse large B-cell lymphoma; NOS: not otherwise specified; HGBL: high-grade B-cell lymphoma; R-CHOP: rituximab-CHOP; R-CHP: rituximab-CHP; OS: overall survival; AVEPC: doxorubicin-vincristine-etoposide-prednisone-cyclophosphamide; la/mUC: locally advanced or metastatic urothelial carcinoma; Pembro: pembrolizumab