Kevzara fails to meet endpoints in ex-US phase 3 trial for severe COVID-19
Sanofi announced that its IL-6 inhibitor Kevzara failed to meet primary and secondary endpoints in a phase 3 trial of patients outside the United States hospitalized with severe COVID-19.
“Although this trial did not yield the results we hoped for, we are proud of the work that was achieved by the team to further our understanding of the potential use of Kevzara for the treatment of COVID-19,” John Reed, MD, PhD, global head of research and development at Sanofi, said in a company press release.
“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,” he added. “At Sanofi, we are committed to help combat the global COVID-19 pandemic, including developing vaccine candidates that can be manufactured at large scale.”
The randomized trial included 420 patients who were severely or critically ill with COVID-19, recruited from hospitals in Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia and Spain. Among the participants, 161 received 200 mg of Kevzara (sarilumab), 173 were treated with 400 mg and 86 received a placebo.
According to the press release, although not statistically significant, the researchers observed numerical trends toward a decrease in hospital stay duration as well as faster time to better clinical outcomes, defined as a two-point improvement on a seven-point scale. In addition, the researchers noted a trend toward reduced mortality in the critical patient group, but not in the severe group. Lastly, the time to discharge was reduced by 2 to 3 days among patients who received sarilumab within the first 2 weeks of treatment, although, again, this was not statistically significant.
Regarding safety, 26% to 29% of patients treated with sarilumab, and 24% who received a placebo, experienced serious adverse events. The incidence of deadly adverse events was approximately 10% in all three treatment groups. Serious infections, including COVID-19 pneumonia, were reported in 11% to 13% of participants treated with sarilumab and in 12% of those who received a placebo.
According to Sanofi, the results of this trial will be submitted to a peer-reviewed publication later this year. The company stated it does not anticipate conducting further clinical studies for the drug in treating COVID-19.