Sanofi said Tuesday that a Phase III trial investigating Kevzara (sarilumab) in severely or critically ill patients hospitalised with COVID-19 failed to meet its primary endpoint and key secondary goal. The company and partner Regeneron Pharmaceuticals noted that they "do not anticipate conducting further clinical studies" of the IL-6 receptor antibody for COVID-19.
John Reed, Sanofi's global head of R&D, remarked "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." In July, the drugmakers reported that a late-stage trial of Kevzara in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints when the IL-6 receptor antibody was added to best supportive care, versus best supportive care alone.
The latest study randomised 420 patients to receive Kevzara at one of two doses or placebo added to usual hospital care. The primary endpoint was time to improvement of two points or greater on a seven-point clinical scale, while the key secondary goal was percentage of patients alive at day 29.
Sanofi said that while not statistically significant, numerical trends were observed toward a decrease in duration of hospital stay, as well as an acceleration in time to improve clinical outcomes, as measured by a two-point improvement from baseline on the seven-point scale. Further, a trend was observed towards reduced mortality in the critical patient group, which was not seen in the severe patient group. In addition, the time to discharge was shortened by two to three days in patients given Kevzara within the first two weeks of treatment, although the difference was not significant.
According to Sanofi, serious adverse events were experienced by between 26% and 29% of Kevzara patients, compared to 24% of those given patients, while serious infections were observed in 11% to 13% of those administered the IL-6 receptor antibody, versus 12% for placebo. The company added that the incidence of adverse events leading to death was approximately 10% in all three treatment arms. The drugmaker said that detailed results will be submitted to a peer-reviewed publication later this year.
Kevzara is currently approved in a number of countries to treat adults with moderately-to-severely active rheumatoid arthritis who have not responded to or tolerated previous therapy.
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