Lenzilumab Significantly Improves COVID-19 Survival Without Invasive Ventilation
For hypoxic patients hospitalized with COVID-19, lenzilumab significantly improved survival without invasive mechanical ventilation (SWOV) compared to placebo, according to the results of the phase 3 trial presented virtually at IDWeek 2021.
The potential of lenzilumab to improve clinical outcomes for patients with COVID-19 is based on its ability to neutralize granulocyte and macrophage colony stimulating factor (GM-CSF), a key immune-mediated cytokine that is part of the “storm” of the inflammatory response that occurs with Covid19 infection. The researchers set out to test the efficacy and safety of the new monoclonal antibody as well as the treatments available in this randomized, double-blind, placebo-controlled trial.
A total of 520 patients were included in the analysis. These people were hypoxic and required supplemental oxygen, but not invasive mechanical ventilation. Participants were randomized on day 0 to receive either lenzilumab (1800 mg, n = 261) or placebo (n = 259), along with available treatments (such as remdesivir and / or corticosteroids). The investigators monitored the results and followed the patients for 28 days, with a primary endpoint of SWOV and a secondary endpoint of incidence of invasive mechanical ventilation (IMV), extracorporeal membrane oxygenation (ECMO). or death.
Between study arms, baseline demographics were comparable: 64.7% males, median age 60.5 years, median C-reactive protein level 79.0 mg / L. In addition to the study drug or placebo, many patients in both groups received steroids (93.7%), remdesivir (72.4%), or both (69.1%).
In the modified intention-to-treat population, administration of lenzilumab improved SWOV 1.54-fold (HR: 1.54; 95% CI: 1.02-2.32, P = .0403), and by 1.91 times (nominal P = 0.0073) and 1.92 times (nominal P = 0.0067) in patients receiving remdesivir or remdesivir and corticosteroids, respectively.
In patients receiving remdesivir or remdesivir and corticosteroids, the secondary endpoint of the incidence of GMI, ECMO, or death also improved (P = .020 and P = 0.0180, respectively). Both groups also experienced similar reports of serious treatment-related adverse events.
“Lenzilumab significantly improved SWOV in COVID-19 hypoxic patients during hospitalization, with the greatest benefit seen in patients receiving treatment with remdesivir and corticosteroids,” the investigators concluded.
The study, “Efficacy and Safety of Lenzilumab in Newly Hospitalized COVID-19 Subjects: Results of a Phase 3, Double-Blind, Placebo-Controlled Randomized Trial,” was presented virtually at IDWeek 2021, which was held. held from September 29 to October 3, 2021.