Roche’s phase III EMPACTA study showed Actemra/RoActemra reduced the likelihood of needing mechanical ventilation in hospitalised patients with COVID-19 associated pneumonia

• EMPACTA is the first global phase III trial to show efficacy with Actemra/RoActemra in COVID-19 associated pneumonia and the first with a focus on enrolling largely underserved and minority patients
• There was no statistical difference in mortality between patients who received Actemra/RoActemra or placebo
• Roche plans to share these results with health authorities, including the US FDA
  
  

Basel, 18 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the phase III EMPACTA study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received Actemra/RoActemra (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/RoActemra arm versus 19.3% in the placebo arm. The EMPACTA study did not identify any new safety signals for Actemra/RoActemra.

“The EMPACTA trial demonstrated that Actemra/RoActemra can reduce the need for mechanical ventilation in patients with COVID-19 associated pneumonia, an important outcome in this serious disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We plan to share this important data with the US Food and Drug Administration (FDA) and other health authorities around the world.”

The study is the first global, phase III COVID-19 clinical trial to primarily enrol 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.

“We have been striving to improve inclusion and diversity in our trials,” said Jamie Freedman, M.D., Ph.D., Head of U.S. Medical Affairs. “During the COVID-19 pandemic, we saw how high the stakes were for many communities of colour and made diversity the centerpiece of this trial.”

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