Another Kevzara study in hospitalized COVID-19 patients failed to meet primary and secondary endpoints. This marks the second such failed study for Kevzara and at least the third with IL-6 inhibitors as a potential treatment for these patients.
This morning, Sanofi announced the disappointing results from the Phase III study of intravenously-dosed Kevzara (sarilumab). Sanofi and its developmental partner Regeneron launched the study in April outside the United States. The study, which was conducted in Italy, Spain, Germany, France, Japan, Canada and Russia, assessed Kevzara doses of 200mg and 400 mg in severely or critically ill patients hospitalized with COVID-19. The hope was for Kevzara, and Interleukin-6 inhibitor, to calm an overactive immune response in these patients. Following some anecdotal success with Roche’s Actemra in China in the early days of the COVID-19 outbreak, it had been thought that IL-6 may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19 infection.
John Reed, Sanofi’s Global Head of Research and Development, expressed his disappointment in the outcomes of this study.
“In times like these, commitment to properly designed, controlled clinical trials, provides the information and understanding the scientific community needs for fact-based decision making. At Sanofi, we are committed to help combat the global COVID-19 pandemic, including developing vaccine candidates that can be manufactured at large-scale,” Reed said in a statement.
While the trial failed to hit its primary and secondary endpoints, Sanofi said it noticed some positive numerical trends, although they were not statistically significant. Those trends were a decrease in duration of hospital stay as well as an acceleration in time to improve clinical outcomes, the company said. A trend was also observed towards reduced mortality in the critical patient group which was not seen in the severe patient group and the time to discharge was shortened by 2-3 days in patients who were treated with Kevzara. Again though, these were not considered statistically significant, the company added.
There were some serious adverse events in the study. Sanofi said 26-29% of Kevzara patients and 24% of placebo patients experienced some negative issues. Serious infections (including COVID-19 pneumonia) were observed in 11-13% of Kevzara patients and 12% of placebo patients. Detailed results of the study will be submitted to a peer-reviewed publication later this year.
The latest Kevzara let down in COVID-19 follows data from a Phase III study of Kevzara in COVID-19 patients requiring mechanical ventilation released in July that showed the study did not meet its primary and key secondary endpoints. The trial was stopped following those results, although the companies said they did observe some “minor positive trends” in the primary pre-specified analysis group.
That same month, Genentech, a Roche company, reported that Actemra, another IL-6 inhibitor, failed to meet primary and secondary endpoints in a COVID-19 related study. Like Kevzara though, Genentech said it saw some positive trends with Actemra, but they were not statistically significant.
With the disappointing results in hand, Sanofi and Regeneron said they do not anticipate conducting further clinical studies for Kevzara in COVID-19.