Lenzilumab May Best Improve COVID-19 Survival Without Ventilation in Black, African American Patients

Hospitalized Black and African American patients with COVID-19 having a c-reactive protein level (CRP) <150 mg/L may be the most responsive population to treatment with lenzilumab, according to the results of the phase 3 LIVE-AIR study. The study results indicated a nearly 9-fold increase in likelihood of survival without ventilation (SWOV) among this population, compared to a 2.5-fold increased likelihood of SWOV in the overall population.

“In light of the rapid ongoing spread of the Delta variant, data suggesting that Black and African American patients, who are hyper-vulnerable to COVID-19, and may be hyper-responsive to lenzilumab is important in the broader context of the potential benefits that may result if the FDA were to grant emergency use authorization,” said Cameron Durrant, MD, chief executive officer at Humanigen, in a press release.

The LIVE-AIR phase 3 study, a randomized, double-blind, placebo-controlled, multi-center trial for the treatment and prevention of serious and potentially fatal outcomes in patients hospitalized with COVID-19 pneumonia, enrolled 520 patients in 29 sites in the United States and Brazil who were at least 18 years of age. The study met its primary endpoint of survival without ventilation, demonstrating a 1.54-fold improvement overall.

This improvement trended toward a 2.68-fold improvement in Black and African American patients. The primary objective of the study was to analyze whether lenzilumab, in combination with other treatments, could alleviate the immune-mediated cytokine storm and improve SWOV.

According to the investigators, the CDC has found that race and ethnicity are risk markers for other conditions that affect health, including socioeconomic status, access to health care, and exposure to SARS-CoV-2 related to occupation. Further, the American Heart Association’s COVID-19 Cardiovascular Disease Registry found that Black patients had the highest prevalence of obesity, hypertension, and diabetes, all of which are medical conditions the CDC identifies as making adults of any age more likely to get severely ill from COVID-19.

“In the interest of public health and safety, it is our priority to share data with stakeholders to improve our understanding of the disease and potential treatments,” said Adrian Kilcoyne, MD, chief medical officer, Humanigen, in a press release. “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.”

REFERENCE

Lenzilumab treatment may provide enhanced likelihood of survival without ventilation in hospitalized Black and African American COVID-19 patients [news release]. Business Wire; August 4, 2021. Accessed August 5, 2021. https://www.businesswire.com/news/home/20210804005396/en