A phase 3 trial evaluating tocilizumab (Actemra®) in combination with remdesivir (Veklury®) for the treatment of severe COVID-19 pneumonia did not meet its primary end point.
The global, multicenter, double-blind REMDACTA study (ClinicalTrials.gov: NCT04409262) evaluated the efficacy and safety of tocilizumab plus remdesivir in hospitalized patients with severe COVID-19 pneumonia receiving standard of care. Patients were randomly assigned to receive either tocilizumab plus remdesivir or placebo plus remdesivir, and were followed for 60 days post-randomization.
Results showed that treatment with tocilizumab plus remdesivir did not meet the primary end point of improvement in time to hospital discharge by day 28. Moreover, tocilizumab plus remdesivir did not meet key secondary end points, which included likelihood of death, likelihood of progression to mechanical ventilation or death, and clinical status. There were no new safety signals identified for tocilizumab.
Full study data will be submitted for publication in a peer-reviewed journal later this year.
“Given the global impact of COVID-19 pneumonia on patients, we are disappointed that the REMDACTA study did not meet its end points,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “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.”
Tocilizumab has also been evaluated for COVID-19 pneumonia in the COVACTA study (ClinicalTrials.gov: NCT04320615), which did not meet its primary end point (improved clinical status), and the EMPACTA study (ClinicalTrials.gov: NCT04372186), which showed that patients treated with tocilizumab were 44% less likely to progress to mechanical ventilation or death compared with those who received placebo.
Genentech provides update on the phase III REMDACTA trial of Actemra plus Veklury in patients with severe COVID-19 pneumonia. [press release]. South San Francisco, CA: Genentech; March 11, 2021.