Roche has reported that its Actemra/RoActemra (tocilizumab) reduced the need for mechanical ventilation in hospitalised Covid-19 patients with associated pneumonia in the Phase III EMPACTA clinical trial.
The trial met the primary endpoint, with patients on Actemra plus standard of care found to be 44% less likely to progress to mechanical ventilation or death versus those on placebo plus standard of care.
Compared with 9.3% in the placebo group, the cumulative proportion of participants progressing to mechanical ventilation or death by day 28 was 12.2% with Roche’s drug.
Meanwhile, the difference in time to hospital discharge or difference in time to improvement in ordinal clinical status to day 28 was not significant between the study drug and placebo groups.
Roche added that time to clinical failure to day 28 was longer in the Actemra arm compared with the placebo group, but was not statistically significant.
Furthermore, no statistical difference was observed in mortality between the study drug and placebo arms by day 28.
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Investigators did not report any new safety signals for Actemra. The incidence of infections was 10% and 11% in the study drug and placebo groups, respectively, at day 28.
Roche chief medical officer and Global Product Development head Levi Garraway said: “The EMPACTA trial demonstrated that Actemra/RoActemra can reduce the need for mechanical ventilation in patients with Covid-19 associated pneumonia, an important outcome in this serious disease.
“We plan to share this important data with the US Food and Drug Administration (FDA) and other health authorities around the world.”
EMPACTA recruited 389 patients in the US, South Africa, Kenya, Brazil, Mexico and Peru. It is said to have mainly enrolled patient populations that are usually underrepresented in clinical trials.
Roche is also assessing Actemra in different trials to potentially treat Covid-19-related pneumonia, including in combination with an antiviral in the Phase III REMDACTA trial.
In July, Roche reported that the drug failed to meet the primary endpoint of improved clinical status in the Phase III COVACTA trial involving hospitalised adults with severe Covid-19-related pneumonia.