Roche said that a phase 3 study investigating Actemra/RoActemra (tocilizumab) in hospitalized adults with severe COVID-19-associated pneumonia failed to meet its primary endpoint of improved clinical status. The company launched the COVACTA trial in March in order to investigate the anti-IL-6 receptor biologic in a well-controlled study.
The trial, which was conducted in collaboration with the US Biomedical Advanced Research and Development Authority (BARDA), evaluated intravenous Actemra/RoActemra added to standard-of-care compared to treatment with placebo plus standard of care. The primary endpoint of clinical status was measured by a seven-category ordinal scale that tracked patients’ clinical status based on the need for intensive care and/or ventilator use, as well as supplemental oxygen requirements.
Key secondary goal also missed
Results showed that the difference in clinical status between Actemra/RoActemra and placebo at week 4 was not significant. In addition, there was no difference between the two groups in the percentage of patients who died by week four, a key secondary goal of the study, with rates of 19.7% and 19.4%, respectively.
However, Roche indicated that there was a positive trend in time to hospital discharge in patients treated with its drug. Data showed that the median time to discharge or “ready to discharge” for Actemra/RoActemra was 20 days, versus 28 days for placebo, although the company noted that the difference cannot be considered significant as the primary endpoint was not met. The difference in ventilator-free days between Actemra/RoActemra and placebo was also not significant, with a median of 22 days and 16.5 days in the two groups, respectively.
Roche added that at week 4, rates of infections were 38.3% and 40.6% in the Actemra/RoActemra and placebo arms, respectively, and the rates of serious infections were 21.0% and 25.9%, respectively. The drugmaker said that further analysis of the results, which will be submitted for publication in a peer-reviewed journal, is needed to fully understand the data.
Other studies continue
Along with COVACTA, Roche is also investigating Actemra/RoActemra as a potential treatment for patients with COVID-19-associated pneumonia in the Phase III REMDACTA and EMPACTA studies, as well as the phase 2 MARIPOSA trial. Meanwhile, the RECOVERY study, which is being conducted in the UK by the University of Oxford, will continue investigating Roche’s drug. “We are investigating the use of [Actemra/RoActemra] for sicker patients, whereas the Roche trial looked at patients with milder disease,” a spokeswoman for the RECOVERY trial said.
Commenting on the COVACTA findings, Bank Vontobel analysts remarked “for COVID-19 patients in need of an effective treatment, today’s news is disappointing. From an investment perspective, we never assumed a pandemic-driven long-term increase of Actemra revenues.”