#HGEN announced the first case-control data of #lenzilumab in severe COVID-19 demonstrating an 80% reduction in relative risk of invasive mechanical ventilation (IMV) and/or death for patients treated with lenzilumab compared to the matched control group. The manuscript, titled “GM-CSF neutralization with lenzilumab in severe COVID-19 patients: A case-control study” was published in Mayo Clinic Proceedings, a premier peer-reviewed journal.
The study involved a total of 39 patients, including 12 treated with lenzilumab, and 27 contemporaneous matched control patients who received standard of care treatment.
Lenzilumab treatment was associated with a reduction in risk of progression to IMV and/or death compared to matched controls (8% vs. 41%, p=0.07). Median time to resolution of acute respiratory distress syndrome (ARDS) was one day in the lenzilumab treatment arm versus eight days in the control group (p<0.001). Patients treated with lenzilumab were discharged in a median of five days versus 11 days in the control arm (p=0.008).
Lenzilumab treatment was also associated with a significant reduction in the inflammatory marker c-reactive protein (CRP) relative to the control group (p=0.01) and an improvement in lymphocyte counts relative to the control group (p=0.04).
These data suggest that GM-CSF neutralization with lenzilumab may restore balance to the dysregulated immune response induced by SARS-CoV-2 by supressing the myeloid inflammatory response and improving T-cell counts that are thought to be responsible for viral clearance. There were no treatment-emergent adverse events attributable to lenzilumab.
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