Although the company has ended the ACTIV-3 clinical trial, researchers are continuing to pursue all other studies of bamlanivimab in COVID-19.
Investigators from Eli Lilly’s ACTIV-3 clinical trial investigating bamlanivimab in patients hospitalized with coronavirus disease 2019 (COVID-19) have discontinued the trial after concluding that the therapy showed no benefit. No additional COVID-19 patients in the hospitalized setting will receive bamlanivimab, according to a statement by Eli Lilly.1
The decision was based on review of an updated dataset on October 26, which also determined that differences in safety outcomes between the study groups were not significant.1
On October 13, 2020, Eli Lilly announced it had paused the study based on the independent data safety monitoring board (DSMB) recommendation to stop enrollment due to a potential safety concern.2
On Monday, Lilly reported that, although the treatment was determined not to pose significant safety risks, trial data indicated that bamlanivimab is unlikely to benefit hospitalized patients with COVID-19.1
However, all other studies from Eli Lilly, sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, will continue, including ACTIV-2, which is assessing recently diagnosed COVID-19 patients with mild-to-moderate manifestations, as well as:1
Following favorable results in the BLAZE-1 trial, Lilly submitted a request to the FDA in early October for an emergency use authorization for bamlanivimab for the treatment of recently diagnosed COVID-19 patients with mild-or-moderate infection in high-risk patients.1
“While there was insufficient evidence that bamlanivimab improved clinical outcomes when added to other treatments in hospitalized patients with COVID-19, we remain confident based on data from Lilly’s BLAZE-1 study that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of COVID-19,” the company said in the statement.1