Sanofi and Regeneron have reported that a late-stage trial assessing the potential of arthritis drug Kevzara (sarilumab) has been stopped after it failed to hit targets.
The Phase III trial of Kevzara 400mg in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints when Kevzara was added to best supportive care compared to best supportive care alone (placebo).
The firms did note that “minor positive trends” were observed in the primary pre-specified analysis group (critical patients on Kevzara 400mg who were mechanically ventilated at baseline) that did not reach statistical significance but that these were countered by negative trends in a subgroup of critical patients who were not mechanically ventilated at baseline.
In the primary analysis group, adverse events were experienced by 80% of Kevzara patients and 77% of placebo patients.
Serious adverse events that occurred in at least 3% of patients and more frequently among Kevzara patients were multi-organ dysfunction syndrome (6% Kevzara, 5% placebo) and hypotension (4% Kevzara, 3% placebo).
Based on the results, the US-based trial has been stopped, including in a second cohort of patients who received a higher dose of Kevzara (800mg).
Detailed results are to be submitted to a peer-reviewed publication later this year.
A separate Sanofi-led trial outside of the US in hospitalised patients with severe and critical COVID-19 using a different dosing regimen is ongoing.
The same Independent Data Monitoring Committee (IDMC) is overseeing both the Regeneron-led US trial and the Sanofi-led trial outside of US, which has recommended that the latter continue. The companies expect to report results in Q3 2020.
3rd July 2020