Eli Lilly Ends Trial for Bamlanivimab in Hospitalized COVID-19 Patients

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

1. BLAZE-1: a phase 2 trial evaluating bamlanivimab as a monotherapy and in combination with etesevimab for individuals recently diagnosed with COVID-19 in the ambulatory setting
2. BLAZE-2: a phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities

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 

References:

1. Lilly Statement Regarding NIH’s ACTIV-3 Clinical Trial. News Release. Eli Lilly and Company; October 25, 2020. Accessed October 27, 2020. https://www.lilly.com/news/stories/statement-activ3-clinical-trial-nih-covid19.
2. Romo V. Eli Lilly Ends Antibody Trial In Hospitalized COVID-19 Patients, Other Trials Go on. NPR. October 26, 2020. https://www.npr.org/sections/coronavirus-live-updates/2020/10/26/928072014/eli-lilly-ends-coronavirus-antibody-treatment-trial-other-studies-go-on.