Eli Lilly and Company announced new data from the randomised, double-blind, placebo-controlled BLAZE-1 Phase 3 study, demonstrating bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together significantly reduced COVID-19 related hospitalizations and deaths (“events”) in high-risk patients recently diagnosed with COVID-19. These results provide additional efficacy and safety data that support the use of the dose recently granted both Emergency Use Authorization by the US Food and Drug Administration (FDA) and a positive scientific opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
This new Phase 3 cohort of BLAZE-1 included 769 high-risk patients, aged 12 and older with mild to moderate COVID-19 (therapy: n=511; placebo: n=258). There were four events in patients taking bamlanivimab with etesevimab and 15 events in patients taking placebo, representing an 87 per cent risk reduction (p<0.0001). Bamlanivimab and etesevimab together also demonstrated statistically significant improvements on key secondary endpoints. These results are consistent with those seen in other data sets from BLAZE-1: in the previous Phase 3 cohort, bamlanivimab 2800 mg with etesevimab 2800 mg reduced the risk of hospitalisations and deaths by 70 per cent and in the Phase 2 cohort, bamlanivimab alone reduced the risk of hospitalisations and ER visits by approximately 70 per cent. The viral load reductions were also consistent with what was observed in the previous Phase 3 cohort of the study.
In this new Phase 3 cohort, there were four deaths total, all of which were deemed related to COVID-19 and all of which occurred in patients taking placebo; no deaths occurred in patients receiving treatment with bamlanivimab and etesevimab together. Across the two Phase 3 cohorts of the study that have been analysed to date, there have been no deaths in patients receiving treatment with bamlanivimab and etesevimab together, and 14 deaths in patients receiving placebo, 13 of which were deemed COVID-19 related. In this data set, the safety profile of bamlanivimab and etesevimab together was consistent with observations from other Phase 1, Phase 2 and Phase 3 trials evaluating these antibodies.
“These positive results reinforce our previous findings and support the authorised dose of bamlanivimab 700 mg with etesevimab 1400 mg. These compelling data – in addition to the recent EUA from FDA, the CHMP decision from EMA and the recommendation for the therapy in the National Institutes of Health’s COVID-19 Treatment Guidelines – give healthcare providers additional information regarding the use of bamlanivimab and etesevimab together as a potentially life-saving treatment to help those most at risk for severe complications of COVID-19. The consistent results observed in multiple cohorts of this trial over several months, even as new strains of COVID-19 have emerged, indicate bamlanivimab with etesevimab maintains its effects against a range of variants, particularly those circulating in the US,” said Daniel Skovronsky, Lilly’s Chief Scientific Officer and President of Lilly Research Laboratories.
Bamlanivimab alone and bamlanivimab with etesevimab together are authorised under special/emergency pathways, in the context of the pandemic, in the US and the EU. In addition, bamlanivimab alone is authorised for emergency use in Canada, Panama, Kuwait, the UAE, Israel, Rwanda, Morocco and numerous other countries.