Roche’s Actemra Cuts Ventilator Need in COVID-19 Patients

Roche’s late-stage COVID-19 trial of Actemra (tocilizumab) showed the rheumatoid arthritis drug reduced the number of coronavirus patients who progressed to mechanical ventilation, suggesting it might be of benefit as a coronavirus treatment although the drug did not meaningfully lower mortality rates.

The phase 3 trial enrolled 389 hospitalized patients with COVID-19-associated pneumonia and primarily focused on minority and underserved populations.  Just over 12 percent of those treated with Actemra progressed to mechanical ventilation or death compared to 19 percent who received a placebo.

Actemra’s viability as a COVID-19 treatment remains uncertain as the drug failed to show a benefit for hospitalized patients in a study completed in July. Despite that setback, Roche is hoping that the newest data means the drug could still pan out as a coronavirus treatment (DID, July 30).

The phase 3 trial successfully met its primary endpoint, which included both progression to mechanical ventilation and death. According to Roche, 12.2 percent of patients on Actemra died or required mechanical ventilation by day 28 compared to 19.3 percent in the standard of care plus placebo group.

“The primary endpoint was reached based on the significantly different proportion of patients requiring mechanical ventilation and not by the difference in deaths,” a company spokesperson told FDAnews.

The trial did, however, miss the mark on mortality, a secondary endpoint, finding no statistical difference in deaths between patients who received the drug and those given a placebo by the end of the fourth week.

Roche said that it is currently working to analyze the trial data alongside other studies to better understand the drug’s potential benefit-risk for treating COVID-19 pneumonia. — James Miessler