Roche’s Actemra fails in late-stage severe COVID-19 study

Roche’s hopes of repurposing its arthritis med Actmera as a treatment for COVID-19 have fallen flat after the drug failed to meet the primary endpoint in a key phase three trial.

Actemra (tocilizumab) did not meet its primary endpoint of improved clinical status in hospitalised adult patients with severe COVID-19 associated pneumonia in the phase 3 COVACTA study.

Although researchers observed a positive trend in the time it took to discharge patients from hospital following Actmera treatment, the drug failed to meet key secondary endpoints, which included a difference in patient mortality at week four.

The theory behind testing Actemra in this patient setting is based on the idea that its anti-inflammatory properties could counteract the overactive inflammatory responses observed in the lungs of critically ill and severely ill COVID-19 patients.

Unfortunately, this theory is proving less and less convincing, given that Actemra is not the first anti-inflammatory treatment to fail in a pivotal COVID-19 study. Sanofi/Regeneron’s IL-6 inhibitor Kevzara (sarilumab) was also unable to prevent death or help patients come off ventilation among mechanically ventilated patients.

Another anti-inflammatory drug, ABX464, is currently being studied by Abivax as an early treatment for elderly or high-risk patients with confirmed COVID-19. Although this class of drug has failed in severe patient settings so far, there is still some hope that anti-inflammatories could show benefit as an early treatment in patients with moderate disease.

“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 four. We will continue to generate evidence to provide a more complete understanding of Actemra in COVID-19 associated pneumonia,” said Levi Garraway, chief medical officer and head of global product development at Roche.

While Actemra has missed the mark as a monotherapy in the severe COVID-19 setting, Roche is still hoping it can show a benefit alongside other treatments, including Gilead’s antiviral remdesivir. The Swiss pharma company is also evaluating Kevzara in moderate-to-severe COVID-19 patients, with the hopes that the drug could show a benefit in a patient population that is less ill.