FDA and/or EMA-approved combinations of ADCs
| Combination | Approval year | Patient population | Phase | Primary endpoint | Comparator arm | Primary endpoint results | G3–4 AEs |
|---|---|---|---|---|---|---|---|
| Gemtuzumab ozogamicin + daunorubicin + cytarabine | 2017 | Untreated AML; R/R AML | III | EFS | DA | EFS 40.8% vs. 17.1% | 13% vs. 9.2% |
| Gemtuzumab ozogamicin + induction CT and intensification CT | 2020 | Untreated AML pediatric patient | III | EFS | Induction CT and intensification CT | EFS 48% vs. 40.0% | 76% vs. 76% |
| Brentuximab vedotin + AVD | 2018 | Untreated HL | III | PFS | ABVD | PFS 82.1% vs. 78.8% | 83% vs. 66% |
| Brentuximab vedotin + CHP | 2018 | Untreated PTCL/ sALCL | III | PFS | CHOP | PFS 57.1% vs. 44.4% | 66% vs. 65% |
| Brentuximab vedotin + AVEPC | 2022 | Pediatric untreated HL | III | EFS | ABVE-PC | NR | 73.5% vs. 68.2 |
| Polatuzumab vedotin + BR | 2019 | R/R DLBCL | Ib–II | Safety, tolerability, CR rate | BR | CR 40.0% vs. 17.5% | Anemia 28.2% vs. 17.9%, Neutropenia 46.2% vs. 33.3% |
| Polatuzumab vedotin + R-CHP | 2023 | Untreated DLBCL, NOS or HGBL | III | PFS | R-CHOP | PFS 76.7% vs. 70.2% | 60.7% vs. 69.8% |
| Enfortumab vedotin + Pembro | 2023 | Untreated la/mUC | III | PFS/OS | Gemcitabine + Cisplatin/Carboplatin | PFS 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