Denintuzumab mafodotin
Denintuzumab mafodotin (INN; development codes SGN-19A or SGN-CD19A) is a humanized monoclonal antibody-drug conjugate designed for the treatment of CD19-positive acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma.[1][2][3][4] It consists of an anti-CD19 mAb linked to monomethyl auristatin F (MMAF), a cytotoxic agent.[5] This drug was developed by Seattle Genetics.
Monoclonal antibody | |
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Type | Whole antibody |
Source | Humanized (from mouse) |
Target | CD19 |
Clinical data | |
Other names | SGN-19A |
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Denintuzumab refers to the anti-CD19 antibody, and mafodotin refers to MMAF and the chemical linkage.[6]
Clinical trials
The drug is in phase I clinical trials.[7] Preliminary phase I results for B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL) and B-lineage acute lymphocytic leukemia (B-ALL) were presented at the ASH medical conference Dec 2015.[4]
Phase 2
A separate randomized phase 2 trial started in 2015 to evaluate SGN-CD19A in combination with R-ICE chemotherapy for second-line DLBCL.[4] A phase 2 clinical trial in front-line DLBCL is started in 2016.[4] Both trials were terminated by the sponsor based on portfolio prioritization.[8][9]
References
- "About Denintuzumab Mafodotin (SGN-CD19A; 19A)". Seattle Genetics. Archived from the original on 2017-05-17. Retrieved 2019-05-01.
- Statement On A Nonproprietary Name Adopted By The USAN Council - Denintuzumab Mafodotin, American Medical Association.
- World Health Organization (2014). "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 111" (PDF). WHO Drug Information. 28 (2).
- "Seattle Genetics Highlights Data from Denintuzumab Mafodotin (SGN-CD19A) Antibody-Drug Conjugate Program at ASH 2015". www.businesswire.com. December 6, 2015.
- "Seattle Genetics Presents Data from Novel Antibody-Drug Conjugate (ADC) SGN-CD19A at ASH 2013". Seattle Genetics. Archived from the original on 2013-12-21. Retrieved 2019-05-01.
- "Statement on a nonproprietary name adopted by the USAN Council: Mafodotin" (PDF).
- "Search of: SGN-CD19A - List Results - ClinicalTrials.gov". clinicaltrials.gov.
- Clinical trial number NCT02592876 for "Treatment Study of Denintuzumab Mafodotin (SGN-CD19A) Plus RICE Versus RICE Alone for Diffuse Large B-Cell Lymphoma" at ClinicalTrials.gov
- Clinical trial number NCT02855359 for "Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma" at ClinicalTrials.gov