COVID-19: Actemra of Roche shows no efficacy in severe cases: Overseas Phase 3 clinical trial
COVID-19:
Swiss Roche:
On July 29, Chugai’s antibody drug “Actemra” announced, “In clinical trials, we could not achieve the main endpoints.”
For critically ill patients:
Studies in Europe and the United States have found no significant data on pulmonary inflammation or improved mortality.
“Actemra” is used as a treatment for rheumatoid arthritis.
The efficacy of the new corona against the severe pneumonia “cytokine storm” was expected.
Phase 3 clinical trial:
A Phase 3 clinical trial conducted by Roche in 450 seriously hospitalized patients.
The degree of symptom improvement set as the main evaluation item:
There is no statistically significant difference compared to placebo.
Mortality rate is similar to placebo group.
The time to discharge was shorter than that of the placebo group.
Chemical Daily
https://www.chemicaldaily.co.jp/
Roche provides an update on the phase III COVACTA trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 associated pneumonia
COVACTA trial did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia, or the key secondary endpoint of reduced patient mortality
The study is the first global, randomised, double-blind, placebo-controlled phase III trial investigating Actemra/RoActemra in this setting
Roche remains committed to continuing the Actemra/RoActemra clinical trial programme in COVID-19 to further explore
Actemra/RoActemra in other treatment settings, including in combination with an antiviral
Basel, 29 July – Roche (SIX: RO, ROG; OTCQX: RHHBY)
today announced that the phase III COVACTA study of Actemra®/RoActemra® (tocilizumab) did not meet its primary endpoint of improved clinical status in hospitalised 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.