RA Therapy Studied for COVID-19 Does Not Meet Endpoint

Roche announced today its therapy, tocilizumab, did not meet its primary endpoint of improved clinical status in hospitalized adult patients with severe COVID-19 associated pneumonia.

The announcement came from the results of the company’s COVACTA study, a Phase 3 trial.

“People around the world are waiting for further effective treatment options for COVID-19 and we are disappointed that COVACTA did not demonstrate a benefit for patients in either clinical status or mortality at week 4,” Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, said. “We will continue to generate evidence to provide a more complete understanding of Actemra/RoActemra (tocilizumab) in COVID-19 associated pneumonia.”

In addition, the study’s key secondary endpoint, which included the difference in patient mortality at week 4, were not met.

The COVACTA trial is the first global, randomized, double-blind, placebo-controlled phase 3 study to investigate tocilizumab in adult patients hospitalized with severe COVID-19 associated pneumonia, with study locations in the US, Canada, and Europe.

A positive trend witnessed in the trial was the time to hospital discharge in patients treated with tocilizumab. Time to hospital discharge or ‘ready to discharge’ was shorter in patients treated with tocilizumab than in those treated with placebo.

The median time to discharge or ‘ready to discharge’ for tocilizumab was 20 days and for placebo was 28 days (median time [95% CI]: tocilizumab = 20.0 [17.0, 27.0]; placebo = 28.0 [20.0, NE], p=0.0370).

However, the difference cannot be considered statistically significant as the primary endpoint was not met.

Tocilizumab was the first approved anti-IL-6 receptor biologic available in both intravenous and subcutaneous formulations for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA).

Other results from the CONVACTA trial included, there was no difference between tocilizumab and placebo in the percentage of patients that died by week 4; and the difference in ventilator-free days between tocilizumab and placebo was not statistically significant (median of 22 days for Tocilizumab and 16.5 days with placebo, difference in medians [95% CI] = 5.5 [-2.8, 13.0], p=0.3202).

The COVACTA trial was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services.

The study did not identify any new safety signals.