Table 2.
Prior clinical trials of antibody construct therapies.
| Target | Author | Drug (Antibody Construct) | Patient Population | Outcomes |
|---|---|---|---|---|
| CD33 | Ravandi et al. 2018/2020 [67] | AMG330 (anti-CD3 × CD33 BiTE) | 55 patients with R/R-AML | Efficacy: 19% ORR (7% CR, 9% CR with incomplete hematologic recovery, 2% with morphological leukemia free state) Safety: 90% AE rate; 67% CRS (13% ≥ grade 3), nausea (20%) |
| CD33 (HLE *) | Subklewe et al. 2019 [68] | AMG673 (Half-Life Extended Anti-CD3 × CD33 BiTE) |
30 patients with R/R-AML | Efficacy: (12/27) 44% with bone marrow blast reduction, 6 of which had >50% reduction in blasts; 1 patient with complete remission with 85% reduction Safety: 50% patients had CRS (13% ≥ grade 3), transaminitis (17%), leukopenia (13%), thrombocytopenia (7%), febrile neutropenia (7%) |
| CD123 | Uy et al. 2021 [69] | Flotetuzumab (anti CD3 × CD123 DART) |
92 R/R-AML patients | Primary induction failure or early relapse cohort (n = 30): Efficacy: 27% with CR/CRh; median OS 10.2 months among responders Safety: 100% CRS (13% ≥ grade) |
| CD123 | Ravandi et al. 2020 [70] | Vibecotamab (XmAb14045; anti CD3 × CD123 BiTE) |
104 R/R-AML, 1 B-cell ALL, and 1 CML |
Efficacy: 14% ORR (4% CR); 71% SD Safety: 59% CRS (15% ≥ grade 3) |
| CD123 | Watts et al. 2021 [71] | APVO436 (anti CD3 × CD123 BiTE) | 22 R/R-AML and 6 R/R-MDS | Efficacy: 2 patients with blast reduction Safety: edema (32%), febrile neutropenia (29%), infusion reaction (21%), CRS (18%) |
* Half-Life Extended (HLE).