Positive interim results were announced from a phase 3 study evaluating lenzilumab, an investigational anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody, for the treatment of patients hospitalized with severe or critical coronavirus disease 2019 (COVID-19) pneumonia.
Study patients (N=300) were randomized to receive lenzilumab or placebo in addition to standard of care (SOC); 78% of participants were reported to be on remdesivir or dexamethasone (or another steroid) or both. The primary end point of the trial was the time to recovery, defined as a patient no longer requiring supplemental oxygen or ongoing medical care in the hospital, or who was no longer hospitalized at day 28.
Interim results showed an estimated 37% more recoveries among patients who received lenzilumab compared with those who received SOC alone (calculated hazard ratio [HR] of 1.37). An independent data and safety monitoring board conducted the interim analysis and recommended increasing the target number of events (recoveries) from 257 to 402 to maintain the power of the study at 90%. Humanigen plans to increase enrollment in the study to approximately 515 patients in order to achieve 402 events.
“These interim data demonstrate the potential of lenzilumab as a frontline treatment option for patients hospitalized with COVID-19,” said Cameron Durrant, MD, MBA, chief executive officer of Humanigen. “We are encouraged by these data and the clinically meaningful impact that lenzilumab may have for patients with COVID-19 over and above remdesivir and/or steroids.”
Submission for Emergency Use Authorization with the Food and Drug Administration is expected in the first quarter of 2021.
For more information visit humanigen.com.
Humanigen announces positive interim phase 3 data of lenzilumab™ in patients hospitalized with COVID-19. [press release]. Burlingame, CA: Humanigen, Inc; November 6, 2020.