Lenzilumab increases likelihood of survival among Black patients with COVID-19

Humanigen has announced that its antibody lenzilumab increased the likelihood of survival among certain Black and African American patients with COVID-19.

Lenzilumab is a novel, first in-class product “that binds to and neutralizes granulocyte-macrophage colony-stimulating factor,” according to a company press release.

The data on lenzilumab are from the phase 3 LIVE-AIR trial, which enrolled 520 adults from 29 sites in the United States and Brazil who experienced blood oxygen saturation of 94% or less; or needed low-flow supplemental oxygen, high-flow oxygen support or noninvasive positive pressure ventilation; and were hospitalized but did not require invasive mechanical ventilation. Patients were randomly assigned to receive either three infusions of lenzilumab or placebo every 8 hours over a 24-hour period.

According to Humanigen, the study met its primary endpoint — survival without ventilation — by showing a 1.5-fold improvement among the overall cohort and a 2.68-fold improvement among Black and African American patients.

The company reported that Black and African American patients with a C-reactive protein (CRP) less than 150 mg/L appeared to have the highest response to treatment with lenzilumab, with an almost ninefold increase in the probability of survival without ventilation (P = .0412). The overall population with a CRP less than 150 mg/L had a 2.5-fold increased probability of survival without ventilation (P = .0009), according to the release.

Humanigen said the data will be shared with the FDA, European Medicines Agency and other regulatory authorities.

“While there may be some limitations to subset analyses, we believe the ongoing public health crisis caused by SARS-CoV-2 warrants consideration of these important data by regulatory authorities,” Adrian Kilcoyne, MD, the chief medical officer of Humanigen, said in the press release.

The rapid spread of the delta variant further highlights the importance of sharing the data, according to Cameron Durrant, MD, CEO of Humanigen.

“Data suggesting that Black and African American patients, who are hyper-vulnerable to COVID-19 and may be hyper-responsive to lenzilumab, are important in the broader context of the potential benefits that may result if the FDA were to grant emergency use authorization,” he said.

The company added that it will likely submit the phase 3 LIVE-AIR data — including “key” secondary endpoints of ventilator-free days, duration of ICU stay, incidence of invasive mechanical ventilation, extracorporeal membrane oxygenation after 28 days, death, time to death, all-cause mortality and time to recovery — to a peer-reviewed journal for publication and present the results at a medical meeting.