Roche’s Actemra Fails to Meet Primary and Secondary Endpoints in Phase 3 COVID-19 Associated Pneumonia Study

Roche (Basel, Switzerland) has announced that the first global, randomized, controlled Phase 3 trial investigating Actemra (tocilizumab) in patients with COVID-19 associated pneumonia did not meet its primary endpoint of improved clinical status or the key secondary endpoint of reduced mortality.

Actemra was the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. The COVACTA trial is the first global, randomized, double-blind, placebo-controlled Phase III study to investigate Actemra in adult patients hospitalized with severe COVID-19 associated pneumonia, with study locations in the US, Canada and Europe. COVACTA evaluated the safety and efficacy of intravenous Actemra added to standard-of-care treatment and compared to treatment with placebo plus standard of care. The primary endpoint of clinical status in hospitalized patients with severe COVID-19 pneumonia 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.

Genentech, a member of the Roche Group, which conducted the Phase 3 COVACTA study of Actemra has now announced that the trial did not meet its primary endpoint of improved clinical status in hospitalized adult patients with severe COVID-19 associated pneumonia. In addition, the key secondary endpoints, which included the difference in patient mortality at week four, were not met; however, there was a positive trend in time to hospital discharge in patients treated with Actemra. The COVACTA study did not identify any new safety signals for Actemra, although further analysis of the trial results is needed to fully understand the data.

“People around the world are waiting for further effective treatment options for COVID-19 and we are disappointed that COVACTA did not demonstrate a benefit for patients in either clinical status or mortality at week four. We will continue to generate evidence to provide a more complete understanding of Actemra in COVID-19 associated pneumonia,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We are grateful for the patients and physicians around the world who helped us to complete this study quickly during a public health crisis, while upholding the highest standards of scientific rigor. We will keep working to help combat the COVID-19 pandemic.”