Roche provides an update on the phase III COVACTA trial in hospitalized COVID-19 patients

Roche has announced that the phase III COVACTA study of Actemra^®/RoActemra^® (tocilizumab) 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/RoActemra. The COVACTA study did not identify any new safety signals for Actemra/RoActemra. Further analysis of the trial results is needed to fully understand the data. The results will be submitted for publication in a peer-reviewed journal.

“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/RoActemra in COVID-19 associated pneumonia,” said Levi Garraway, M.D., Ph.D., Roche’s 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 rigour. We will keep working to help combat the COVID-19 pandemic.”

The COVACTA trial was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services.

COVACTA evaluated the safety and efficacy of intravenous Actemra/RoActemra added to standard-of-care treatment compared to treatment with placebo plus standard of care. The primary endpoint of clinical status in hospitalized adult patients with severe COVID-19 associated pneumonia was measured by a 7-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. The COVACTA trial is the first global, randomized, double-blind, placebo-controlled phase III study to investigate Actemra/RoActemra in adult patients hospitalized with severe COVID-19 associated pneumonia, with study locations in the US, Canada and Europe.

Summary of Key COVACTA Clinical and Safety Findings

• Primary endpoint not met: The difference in clinical status between Actemra/RoActemra and placebo in patients assessed using a 7-category ordinal scale at week four was not statistically significant (p=0.36; odds ratio [95% CI] = 1.19 [0.81, 1.76], a statistically significant odds ratio greater than 1 would have favoured Actemra/RoActemra).
• There was no difference between Actemra/RoActemra and placebo in the percentage of patients that died by week four (Actemra/RoActemra = 19.7% and placebo = 19.4% with a difference [95% CI] of 0.3% [-7.6%, 8.2%], p=0.9410)
• Time to hospital discharge or ‘ready to discharge’ was shorter in patients treated with Actemra/RoActemra than in those treated with placebo. The median time to discharge or ‘ready to discharge’ for Actemra/RoActemra was 20 days and for placebo was 28 days (median time [95% CI]: Actemra/RoActemra = 20.0 [17.0, 27.0]; placebo = 28.0 [20.0, NE], p=0.0370). However, the difference cannot be considered statistically significant as the primary endpoint was not met.
• The difference in ventilator-free days between Actemra/RoActemra and placebo was not statistically significant (median of 22 days for Actemra/RoActemra and 16.5 days with placebo, difference in medians [95% CI] = 5.5 [-2.8, 13.0], p=0.3202).
• At week four, rates of infections were 38.3% and 40.6% in the Actemra/RoActemra and placebo arms, respectively, and the rates of serious infections were 21.0% and 25.9% in the Actemra/RoActemra and placebo arms, respectively. The COVACTA study did not identify any new safety signals for Actemra/RoActemra.

In addition to COVACTA, Roche has initiated several studies to further investigate Actemra/RoActemra as a potential treatment for patients with COVID-19 associated pneumonia, including two phase III clinical trials, REMDACTA and EMPACTA, as well as the phase II MARIPOSA trial. There are also a number of independent trials of Actemra/RoActemra in this setting. Actemra/RoActemra has not previously been studied in, nor approved for, COVID-19 associated pneumonia.

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