An autoimmune drug that failed in a previous clinical trial to improve conditions for patients with severe Covid-19 has shown efficacy in a second study.
Basel, Switzerland-based Roche said Friday that the 389-patient Phase III EMPACTA study comparing Actemra (tocilizumab) on top of standard of care against standard of care and placebo had produced a statistically significant reduction in the number of patients with Covid-19 pneumonia who progressed to requiring mechanical ventilation over a 28-day period.
According to the data, 12.2% of patients in the Actemra group progressed to mechanical ventilation by day 28, compared with 19.3% of those in the placebo arm. However, there was no statistical difference in terms of mortality. Other endpoints, including the time before which patients were ready for discharge and the ordinal scale indicating clinical status, also did not reach statistical significance.
“The EMPACTA trial demonstrated that Actemra/RoActemra can reduce the need for mechanical ventilation in patients with Covid-19-associated pneumonia, an important outcome in this serious disease,” Roche Chief Medical Officer Levi Garraway said in a statement, using both the U.S. and ex-U.S. trade names for the drug. He added that the company plans to take the data to the Food and Drug Administration.
The results stand in contrast to those of a previous Phase III study of Actemra, COVACTA, which the company said in late July had failed to meet its primary endpoint. However, that trial used a different primary endpoint, namely improvement on a seven-point ordinal scale measuring patients’ condition, whereas EMPACTA looked specifically at the proportion of patients who progressed to requiring ventilation.
Actemra is an IL-6 inhibitor normally used to treat certain autoimmune diseases and also cytokine release syndrome, a kind of immune system overreaction, in patients receive CAR-T cell therapies for cancers. Another Phase III study of an IL-6 inhibitor, Kevzara (sarilumab), sponsored by Regeneron Pharmaceuticals and Sanofi, had also failed.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Notably, Roche said EMPACTA was the first global, Phase III trial in Covid-19 to primarily enroll patients from underrepresented groups, with about 85% of them coming from racial and ethnic minorities. A majority were Latino, with Native American and Black patients also being represented in significant numbers. Trial sites were located in the U.S., Mexico, Brazil, Peru, Kenya and South Africa.
Photo: Roche
