Early Results from the First-in-human Study of SAR443579 in R/R AML, B-cell ALL, or High-risk Myelodysplasia

anti-CD123 NKp46×CD16 NK cell engager SAR443579

SAR443579 is a trifunctional natural killer (NK) cell engager targeting CD123 antigen and co-engaging NKp46 and CD16a on NK-cells. SAR443579  facilitates the formation of a cytolytic synapse between NK-cells and CD123-positive tumor cells, leading to NK-cell activation and tumor cell killing. According to the key findings revealed during the ASCO 2023 Conference, at the data cutoff on April 26, 2023, the CR/CRi achieved in 3 of 16 (18.8%) participants that were treated at a maximal target dose of >1000 ug/kg/infusion. Moreover, the maximum time on treatment was 7.6 months. Apart from that, there were two responders who remained in remission after 6.7 and 7.6 months of treatment, respectively.

Noteworthy safety analysis reveals the absence of grade 3 or higher treatment-related adverse events (TRAE), with infusion-related reactions emerging as the most common TRAE. Occurring mainly during C1D1 (Cycle 1, Day 1), these typically resolve within one hour with temporary infusion interruption and effective symptom management strategies.

KOL insights

“We found that SAR’579 was well-tolerated in heavily pretreated patients with refractory AML” –Expert Opinion.


There is a need for better treatment alternatives because the outcomes for Acute Myeloid Leukemia patients following Venetoclax failure are poor. SAR443579 is a trifunctional anti-CD123 NKp46×CD16 NK cell engager and there are several other CD123 targeted therapies, including UCART123, Pivekimab sunirine (IMGN632), Vibecotamab (XmAb-14045), and Tagraxofusp-erzs, are being studied for Acute Myeloid Leukemia treatment. Despite the FDA's first bispecific antibody's clinical success in treating B cell malignancies, there are still numerous challenges to overcome, including dosage, treatment resistance, and modest efficacy. The creation of multispecific antibodies has received a lot of attention in an effort to overcome these limitations, paving new ways to address the intricate biology of cancer and the start of anti-tumor immune responses. Multispecific antibodies are intriguing from the standpoint of health care expenditure. Although early and preliminary study findings, SAR443579 monotherapy was found to be well tolerated, with no dose-limiting toxicities observed throughout the study. It is worth highlighting that the US FDA (Food and Drug Administration) has also granted Fast Track Designation for SAR443579 for the treatment of hematological malignancies. Lastly, with the encouraging findings, the study has been amended and is currently evaluating a higher dose level of SAR443579.

Get a more detailed overview of the key developments in the domain at: Acute Myeloid Leukemia (AML) Market, Acute Myeloid Leukemia Pipeline Insight, Acute Myeloid Leukemia (AML) Epidemiology ForecastNatural Killer T Cell Lymphoma (NKTL) Market, Natural Killer (NK)-Cell Lymphoma Pipeline Insight