I am a Healthcare Professional outside the US and UK

I am a Healthcare Professional outside the US and UK

Click here for international medical scientific information about Oncology for Healthcare Professionals.

I am not a Healthcare Professional and I am outside the US and the UK

I am not a Healthcare Professional and I am outside the US and the UK

Click here for general international information for patients, caregivers and the general public.

Country-specific medical scientific information

Country-specific medical scientific information

Country-specific medical scientific information for Healthcare Professionals.

This site uses cookies to improve your browsing experience. By using this site, you agree to their use. Cookie Information


CD33 monoclonal antibody

BI 836858: an Fc-engineered CD33 monoclonal antibody

BI 836858* is a fully human, monoclonal immunoglobulin G (IgG) 1 antibody against CD33.1 The US Food and Drug Administration granted BI 836858 orphan drug designation for the treatment of acute myeloid leukaemia (AML)2 in June 2014 and for the treatment of myelodysplastic syndrome (MDS)3 in February 2017. Phase I and II studies investigating BI 836858 for the treatment of AML and MDS are ongoing.

The role of CD33

CD33 is a cell-surface myeloid differentiation antigen expressed on malignant cells in AML, chronic myeloid leukaemia (CML), MDS and leukaemic stem cells. It is absent on haematopoietic stem cells.4,5 CD33 is a validated target, notably with the CD33-directed antibody–drug conjugate, gemtuzumab ozogamicin, showing improved overall survival (OS).6 In addition, CD33 plays a direct role in the pathogenesis of MDS by acting as a receptor for S100A9 to initiate suppressive inflammatory signalling that can, in turn, lead to genomic instability. 7

About BI 836858

BI 836858’s mechanism of action

BI 836858 is a fully human IgG 1 CD33 monoclonal antibody (mAb) that binds to CD33 through antigen-specific binding sites. BI 836858 has been engineered to bind to Fcƴ receptors (FcƴRIIIa) of effector cells, such as natural killer (NK) cells, with higher affinity than plasma IgG, thereby mediating more potent antibody-dependent cellular cytotoxicity (ADCC).1

Anti-CD33 monoclonal antibody mechanism of action

Watch BI 836858’s mechanism of action

Watch BI 836858’s mechanism of action

Watch BI 836858’s mechanism of action

Rate this

Preclinical studies

Preclinical studies with BI 836858 have shown high affinity binding of BI 836858 to CD33 and NK‑mediated ADCC against malignant CD33+ AML cells.1 Compared with the CD33 mAb, lintuzumab, BI 836858 showed slower internalisation resulting in higher levels of CD33 retained on the cell-surface and enhanced ADCC against human cells.1

Clinical development

BI 836858 is currently being investigated in Phase I/II trials for the treatment of the myeloid malignancies, AML8–10 and MDS.11




AML, acute myeloid leukaemia; CD, cluster of differentiation; CR, complete response; DLT, dose-limiting toxicity; GvHD, graft-vs-host disease; MTD, maximum tolerated dose; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PK, pharmacokinetics.



BSC, best supportive care; CD, cluster of differentiation; DLT, dose-limiting toxicity; DoR, duration of response; HI-E, haematologic improvement – erythroid; MTD, maximum tolerated dose; ORR, objective response rate; RBC, red blood cell.



Vasu S, et al. Blood 2016;127(23):2879–89.


FDA.gov. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=435614 (Accessed: September 2018).


FDA.gov. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=555316 (Accessed: September 2018).


Ehninger A, et al. Blood Cancer J 2014;4:e218.


Nguyen DH, et al. Exp Hematol 2006;34(6):728–35.


Hills RK, et al. Lancet Oncol 2014;15(9);986–96.


Eksioglu EA, et al. Leukemia 2017;31(10):2172–80.


ClinicalTrials.gov. NCT02632721. https://clinicaltrials.gov/ct2/show/study/NCT02632721 (Accessed: September 2018).


ClinicalTrials.gov. NCT03207191. https://www.clinicaltrials.gov/ct2/show/NCT03207191 (Accessed: September 2018).


ClinicalTrials.gov. NCT03013998. https://clinicaltrials.gov/ct2/show/NCT03013998 (Accessed: September 2018).


ClinicalTrials.gov. NCT02240706. https://clinicaltrials.gov/ct2/show/study/NCT02240706 (Accessed: September 2018).

Did you find this information useful?

Related information

*This is an investigational compound and has not been approved. Its safety and efficacy have not been established.


© 2018 Boehringer Ingelheim International GmbH. All rights reserved.

Last updated: October 2018