Summary of Clinical Use

Lenzilumab has completed Phase 2 clinical trial for uncontrolled asthma, whereas a Phase 2 study in patients with inadequately controlled rheumatoid arthritis has been terminated. A Phase 1 trial in patients with previously treated chronic myelomonocytic leukemia (CMML) is ongoing [3]. SARS-CoV-2 and COVID-19:Lenzilumab has been entered into clinical trial to determine if blocking GM-CSF signalling can help to alleviate the immune-mediated cytokine release syndrome in patients with severe or critical COVID-19 pneumonia. The aim would be reduce the time to recovery in hospitalised patients.

Mechanism Of Action and Pharmacodynamic Effects

The antibody functionally neutralizes soluble GM-CSF. The potential clinical utility of anti-GM-CSF therapy is discussed in [2]. In CMML, cancer cells are hypersensitive to GM-CSF, with their cell growth and survival stimulated in the presence of very low levels of this cytokine. Using lenzilumab to neutralise GM-CSF in in vitro experiments kills CMML cells.

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT04351152	Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Patients With COVID-19	Phase 3 Interventional	Humanigen, Inc.