A drug developed by Genentech for treating rheumatoid arthritis showed positive results in the management of COVID-19-associated pneumonia. A press release by Genentech, a member of the Roche Group, stated that the Phase III EMPACTA study met its primary endpoint, proving that patients with COVID-19 linked pneumonia who received Actemra, an IL-6 inhibitor, together with a standard of care were 44% less likely to advance to ventilation or death compared to patients who were placed on placebo plus standard of care.
Important secondary endpoints, which included the difference in time to hospital discharge or "ready for discharge" to day 28, did not show statistical significance from placebo. There was also no statistical difference in mortality between patients who were given a placebo or Actemra. No safety concerns were recorded for Actemra.
"The EMPACTA trial demonstrated that Actemra could reduce the need for mechanical ventilation in patients with COVID-19 pneumonia, an important outcome in this serious disease," explained Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We plan to share this important data with the FDA and other health authorities around the world."
The study is the first Phase III COVID-19 clinical trial worldwide to primarily enroll participants that were historically underrepresented in clinical studies, with 85% of the 389 participants from minority racial and ethnic groups. The majority of the participants were Hispanic, with substantial representation of Africans and Native Americans. The trial was carried out in the United States, Brazil, South Africa, Mexico, Kenya, 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 color and made diversity the centerpiece of this trial,” he concluded.
The groundbreaking trial builds on Genentech’s earlier work in Advancing Inclusive Research, a cross-organizational U.S. initiative to help checkmate barriers in clinical research for minority racial and ethnic groups who go largely underrepresented in clinical studies.