Lilly Statement Regarding NIH’s ACTIV-3 Clinical Trial
Based on an updated dataset from the trial reviewed on Oct 26, no additional COVID-19 patients in this hospitalised setting will receive bamlanivimab as data suggest it is unlikely to help hospitalized COVID-19 patients recover from this advanced stage of their disease.
Source:
Lilly
SPS commentary:
All other studies of this neutralizing antibody remain ongoing, including ACTIV-2, the NIH-sponsored study in recently diagnosed mild to moderate COVID-19 patients; BLAZE-1, Lilly’s ongoing Phase 2 trial in people recently diagnosed with COVID-19 in the ambulatory (non-hospitalized) setting, studying bamlanivimab as monotherapy and in combination with etesevimab; and BLAZE-2, Lilly’s Phase 3 study of bamlanivimab for the prevention (prophylaxis) of COVID-19 in residents and staff at long-term care facilities.
The New England Journal of Medicine has published data from the monotherapy arms of BLAZE-1, a Phase 2 study assessing the efficacy and safety bamlanivimab in the COVID-19 outpatient setting. Interim analysis found that one of three doses appeared to accelerate the natural decline in viral load over time, whereas the other doses had not by day 11. Based on these data, Lilly submitted a request for Emergency Use Authorization (EUA) to the FDA in early October for bamlanivimab in the treatment of recently diagnosed mild to moderate COVID-19 illness in high-risk patients