Roche’s Actemra/RoActemra Cuts Need for Ventilator Use in COVID-19 Pneumonia

Roche announced results from the EMPACTA study on Friday, showing that patients with COVID-19-associated pneumonia who had Actemra/RoActemra (tocilizumab) added to standard care were 44% less likely to progress to mechanical ventilation or death compared to placebo plus standard care, meeting the phase 3 trial’s primary endpoint. Chief medical officer Levi Garraway said “we plan to share this important data with the FDA and other health authorities around the world.”

EMPACTA enrolled 389 patients over 18 years of age with confirmed SARS-CoV-2 infection whose oxygen saturation levels were below 94% on ambient air and who required neither invasive nor non-invasive mechanical ventilation. Roche noted that the trial consisted primarily of patient populations that have been disproportionately affected by the COVID-19 pandemic, with roughly 85% coming from minority racial and ethnic groups. The majority was Hispanic, and there were “significant [representations]” of Native American and Black populations as well, the company said.

The primary endpoint of the trial assessed the cumulative proportion of patients who died or required mechanical ventilation by day 28. Secondary objectives looked at time to clinical failure, defined as time to death, mechanical ventilation, intensive care admission, or withdrawal, as well as the mortality rate and time to hospital discharge or being “ready for discharge” by day 28.

Secondary goals missed

Roche reported that the cumulative proportion of patients who progressed to mechanical ventilation or death was 12.2% in the Actemra/RoActemra arm, versus 19.3% for placebo. However, there was no significant difference between the two groups in the time to discharge or being “ready for discharge,” or in terms of improvement in ordinal clinical status. There was also no statistical difference in mortality between either group. Roche said the time to clinical failure was longer in the Actemra/RoActemra arm compared to placebo, with a hazard ratio of 0.55, but this “cannot be considered statistically significant as other key secondary endpoints were not met.”

In terms of safety, the incidence of infections at the 28-day mark was 10% and 11% in the Actemra/RoActemra and placebo arms, respectively, while serious infections occurred at rates of 5% and 6.3%. No new safety signals were identified in the EMPACTA trial. Roche said detailed findings would be submitted for publication in a peer-reviewed journal.

Follows COVACTA failure

In late July, Roche reported data from a separate phase 3 study of Actemra/RoActemra dubbed COVACTA, which missed its primary endpoint of improved clinical status in adults hospitalised with severe COVID-19-associated pneumonia. Meanwhile, the drug is also being evaluated in the Phase III REMDACTA study in combination with Gilead Sciences’ antiviral Veklury (remdesivir), against placebo and Veklury, in hospitalised patients with severe COVID-19-associated pneumonia receiving standard of care.

Roche’s anti-IL-6 receptor biologic is approved to treat moderate-to-severe active rheumatoid arthritis, as well as polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and giant cell arteritis. In the US and Europe, Actemra/RoActemra is also cleared to treat CAR-T-cell-induced severe or life-threatening cytokine release syndrome in patients two years of age and older.