Roche Group member Genentech has reported that the Phase III REMDACTA study of Actemra (tocilizumab) plus Veklury (remdesivir) failed to meet its primary, as well as secondary endpoints.
A humanised interleukin-6 (IL-6) receptor antagonist, Actemra is approved for treating adult patients with moderate to severe active rheumatoid arthritis (RA).
Invented and developed by Gilead Sciences, Veklury is an antiviral medicine that works by inhibiting the SARS-CoV-2 replication. It is approved by the US Food and Drug Administration for treating individuals aged 12 years and above needing hospitalisation for Covid-19.
The global, two-armed, randomised, double-blind, multi-centre study analysed the efficacy and safety of Actemra plus Veklury as compared with placebo plus Veklury in hospitalised patients with severe Covid-19 pneumonia receiving standard of care.
In the trial, which is being carried out in partnership with Gilead Sciences, patients were followed up for 60 days after randomisation.
Improvement in time to hospital discharge by day 28 formed the study’s primary endpoint while some of the key secondary endpoints were chances of death, chances of progression to mechanical ventilation or death and clinical status.
Data from the trial of Actemra plus Veklury failed to meet its primary endpoint of improved time to hospital discharge for patients with severe Covid-19 pneumonia, as well as key secondary endpoints versus Veklury alone.
Furthermore, no new safety signals of Actemra were observed in the trial.
Roche Global Product Development chief medical officer and head Levi Garraway said: “Given the global impact of Covid-19 pneumonia on patients, we are disappointed that the REMDACTA study did not meet its endpoints.
“We continue to believe that the totality of data suggests a potential role for Actemra in treating certain patients with Covid-19 and will discuss the results with health authorities.”
Genentech will continue to analyse data from the REMDACTA and other studies of Actemra in patients with Covid-19 pneumonia.