Roche: Actemra, Phase 3 study: Mortality reduced by 44%
Roche: Actemra
September 18, 2020 15:22 JST
On September 18, Roche of Switzerland announced that “Actemra” (generic name tocilizumab) had achieved its primary endpoint in the Phase 3 trial “EMPACTA”.
Briefing paper:
Actemra was administered to inpatients with COVID 19 pneumonia.
As a result, there was a 44% reduction in the chances of needing a ventilator or death compared to patients who received only standard treatment.
Actemra has not yet been approved in any country for the treatment of COVID19-related pneumonia.
Bloomberg
https://www.bloomberg.co.jp/news/articles/2020-09-18/QGUAVXT0G1L001
Roche – Roche’s phase III EMPACTA study showed Actemra/RoActemra reduced the likelihood of needing mechanical ventilation in hospitalised patients with COVID-19 associated pneumonia
EMPACTA is the first global phase III trial to show efficacy with Actemra/RoActemra in COVID-19 associated pneumonia and the first with a focus on enrolling largely underserved and minority patients
There was no statistical difference in mortality between patients who received Actemra/RoActemra or placebo
Roche plans to share these results with health authorities, including the US FDA
Basel, 18 September 2020 –
Roche
today announced that the phase III EMPACTA study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received Actemra®/RoActemra® (tocilizumab) plus standard of care
were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care (log-rank p-value = 0.0348; HR [95% CI] = 0.56 [0.32, 0.97]).
The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra/RoActemra arm versus 19.3% in the placebo arm.
The EMPACTA study did not identify any new safety signals for Actemra/RoActemra.
https://www.roche.com/media/releases/med-cor-2020-09-18.htm
Sep 18,2020 | Roche Announces Results of EMPACTA Study for Chugai’s Actemra for the Treatment of COVID-19 | News | CHUGAI PHARMACEUTICAL CO., LTD.
https://www.chugai-pharm.co.jp/english/news/detail/20200918142400_766.html