ACTIV-3 Trial Using Bamlanivimab is Ending
While this trial for hospitalized COVID-19 patients has been discontinued, Lilly is continuing their other trials with the medication for COVID-19 treatment.
Based upon updated dataset from the ACTIV-3 trial, which was reviewed yesterday, the study is ending.
The ACTIV-3 study was run by the National Institute of Allergy and Infectious Diseases and had been using Eli Lilly's therapy bamlanivimab. All other studies with bamlanivimab are ongoing, according to Lilly. They have 3 other trials related to COVID-19. ACTIV-2 trial is examining recently diagnosed mild to moderate COVID-19 patients.
The BLAZE-1, phase 2 trial in people recently diagnosed with COVID-19 in the ambulatory (non-hospitalized) setting is studying bamlanivimab as monotherapy and in combination with etesevimab. Earlier this month, interim data from the trial showed it was associated with a reduced viral load, symptoms, and hospitalizations or emergency room visits associated with COVID-19.
The BLAZE-2 study is a phase 3 trial examining bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities.
Based on data from BLAZE-1, Lilly submitted a request in early October for an Emergency Use Authorizatio for bamlanivimab for the treatment of recently diagnosed mild to moderate COVID-19 in high-risk patients.
“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 a statement.