Roche Group’s Genentech has reportedly announced that the Phase III COVACTA trial of Actemra has failed to deliver its primary outcome of improved clinical status amongst hospitalized adults diagnosed with severe pneumonia associated with COVID-19. The company has stated that the trails have also not met the key secondary endpoints that comprised the difference in patient mortality during week four. Further, the study has not identified any new safety signals for Actemra. But a positive shift has been registered in time taken for the hospital discharge of patients who were treated with Actemra.
The COVACTA trial was conducted in partnership with the Biomedical Advanced Research and Development Authority (BARDA), which comes under the Office of the Assistant Secretary for Preparedness and Response, the U.S. Department of Health and Human Services.
According to Levi Garraway, the Chief Medical Officer and Head of Global Product Development at Genentech, people across the globe are awaiting effective treatment options for COVID-19 and the company is disappointed that the COVACTA study failed to demonstrate an advantage for patients in either mortality or clinical status at week four.
Garraway has further stated Genentech’s intention to continue to generate evidence for providing a more complete understanding of Actemra in pneumonia associated with COVID-19. The company is grateful for the patients and physicians across the world who upheld the highest standards of scientific rigor and effectively contributed to complete the study at a quicker pace during the pandemic. Genentech further endeavors to work towards a solution that effectively combats COVID-19, added Garraway.
As reported, the COVACTA trial evaluated the efficacy and safety of using intravenous Actemra when added to standard-of-care treatment. The study is the first double-blind, global, randomized, placebo-controlled Phase III trial for the investigation of Actemra in adult patients who have been hospitalized for diagnosis with severe pneumonia associated with COVID-19. The locations of the study are situated in Europe, Canada, and the United States.