In contrast with results for a similar study that failed, Roche announced that a Phase III EMPACTA study showed that patients with COVID-19-associated pneumonia who received Actemra/RoActemra (tocilizumab) plus standard of care were 44 percent less likely to progress to mechanical ventilation or death, compared with patients who received a placebo plus standard of care.
The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2 percent in the Actemra/RoActemra arm versus 19.3 percent in the placebo arm.
Among other, secondary results of the study, researchers found that there was no statistical difference in mortality rate or time-to-discharge between patients who received Actemra or placebo by day 28.
Actemra/RoActemra is used for the treatment of rheumatoid arthritis (RA) and other conditions. The drug works by binding to IL-6 receptors, blocking the pro-inflammatory effect of IL-6 cytokines.
According to Roche, the EMPACTA 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 percent 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 study results were more promising than results Roche released in July from another Phase III study of Actemra/RoActemra (tocilizumab). The earlier study did not meet its primary endpoint of improved clinical status in hospitalized adult patients with severe COVID-19 associated pneumonia. In addition, key secondary endpoints, which included the difference in patient mortality at week four, were not met.
In the earlier study, the primary endpoint of clinical status was measured by a seven-category ordinal scale, which tracked patients’ clinical status based on the need for intensive care and/or ventilator use as well as supplemental oxygen requirements.
Roche also noted that Actemra/RoActemra has not been approved by any health authority for COVID-19 associated pneumonia.
