On Sept. 17, 2020, Genentech, a member of the Roche Group announced that the Phase III EMPACTA study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received Actemra® (tocilizumab) plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care (log-rank p-value = 0.0348; HR [95% CI] = 0.56 [0.32, 0.97]). The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra arm versus 19.3% in the placebo arm. The EMPACTA study did not identify any new safety signals for Actemra.

The study is the first global, Phase III COVID-19 clinical trial to primarily enroll patient populations that are often underrepresented in clinical studies and have been disproportionately affected by the COVID-19 pandemic. Approximately 85% of the 389 patients were from minority racial and ethnic groups. The majority of patients were Hispanic, with significant representation of Native American and Black populations. The trial was conducted in the United States, South Africa, Kenya, Brazil, Mexico and Peru.

The EMPACTA trial builds on Genentech’s work in Advancing Inclusive Research, a cross-organizational U.S. initiative to help address barriers in clinical research for underrepresented racial and ethnic groups.