Table 1.
List of monoclonal antibodies directed against mast cell-associated cell surface markers that have been approved by the US Food and Drug Administration (FDA) and by the European Medicines Agency (EMA) for therapeutic use in humans or that are being evaluated in ongoing clinical trials.
| Targeted Protein (Gene Symbol) | Monoclonal Antibody Name | Mechanism of Action | Year of Approval | Approved Indication(s) | References | ORR (CR) Rates in SM |
|---|---|---|---|---|---|---|
|
CD22
(Siglec-2) |
Inotuzumab ozogamicin | Immunotoxin | 2017 ¥§ | B-cell precursor (BCP) acute lymphoblastic leukemia | [30,31] | - |
| Moxetumomab pasudotox | 2018 § | Hairy cell leukemia | [32,33] | - | ||
|
CD25
(IL2RA) |
Daclizumab | ADCC | 1997 §# 1999 ¥# |
Prophylaxis of acute organ rejection in renal transplantation | [34] | 2/5 (40%) (0/5 (0%)) [28] |
| Basiliximab | 1998 ¥§ | Prophylaxis of acute organ rejection in renal transplantation | [35,36] | - | ||
| Daclizumab | 2016 ¥§# | Relapsing forms of multiple sclerosis | [37,38,39,40] | - | ||
|
CD30
( TNFRFS8) |
Brentuximab vedotin | Immunotoxin/ADCP | 2011 § 2012 ¥ |
Hodgkin lymphoma/cutaneous lymphoma/peripheral T-cell lymphoma | [41,42,43,44,45,46] | 2/4 50% (0/4 (0%)) [29] |
|
CD33
(Siglec-3) |
Gemtuzumab ozogamicin | Immunotoxin | 2000 # 2017 ¥§ |
Acute myeloid leukemia | [47,48,49] | (2/2 (100%)) [27,50] |
|
CD123
(IL3RA) |
Talacotuzumab | ADCC | 2018 * | Acute myeloid leukemia | - | - |
|
FcεRI
(High-affinity immunoglobulin ε heavy chain receptor I) |
Omalizumab | ADCC | 2003 § 2005 ¥ |
Moderate to severe persistent asthma | [51,52,53] | 10/21 (48%) (11/21 (52%)) [54,55,56,57,58,59,60,61,62] |
# Marketing discontinued for the first approved indication. ¥ Year of approval in the European Union. § Year of approval in the United States of America. * Undergoing phase III clinical trials. Abbreviations: ADC, antibody-drug conjugate, ADCC, antibody-dependent cell-mediated cytotoxicity, ADCP, antibody-dependent cellular phagocytosis, CAR, chimeric antigen receptor, CR, complete remission, ORR, overall response rate.