Roche’s IL-6 receptor blocker fails in Phase III

In the COVACTA global Phase III trial Roche’s approved standard medicine for blocking cytokine release syndrome (CRS) did not meet the primary endpoints of improving the clinical status of COVID-19 patients with pneumonia and of reduction in mortality. More previously, Sanofi’s/Regeneron’s IL-6 signalling blocker sarilumab failed to reduce mortality and to reduce disease severity in mechanically ventilated COVID-19 patients.

Certain studies suggested that an increase in IL-6 levels was associated with mortality in COVID-19 patients. Roche, which runs several other studies with tocilizumab in COVID-19 patients including a combination study with the antiviral drug remdesivir, announced it remains committed to the tocilizumab programme.

While, the immunosuppressant dexamethasone has shown some mortality benefit in ventilated COVID-19 patients, it is still not known what kind of immunosuppressors are adequate for certain patient groups. In fact, data published by researchers of the University of Pennsylvania suggest that there are very different patterns of immune reactions to an infection with the novel coronavirus SARS-CoV-2 in different patients: In Science the team headed by John Wherry reported that COVID-19 is characterised by activation of CD8 lymphocytes and associated with heterogeneous CD4 T cell responses and the activation of CD4 T cell subsets. Additionally, they found increased frequencies of plasmablasts and proliferation of memory B cell subsets and that the immune responses changed over time. This suggests that patients need to be stratified to find the optimal immunosuppressive therapy at a specific point in time.

Roche said it is working to fully understand the clinical data.