New data from the BLAZE-1 clinical trial showed that treatment with the authorized dose of Lilly’s SARS-CoV-2 neutralizing antibodies, bamlanivimab plus etesevimab, significantly reduced COVID-19 related hospitalizations and deaths in high-risk patients recently diagnosed with COVID-19.
The randomized, double-blind, placebo-controlled phase 3 study (ClinicalTrials.gov: NCT04427501) evaluated the combination therapy in a new cohort which included 769 high-risk patients aged 12 years and older with mild to moderate COVID-19. Patients were randomly assigned 2:1 to receive bamlanivimab 700mg plus etesevimab 1400mg (n=511) or placebo (n=258).
Results showed a significantly lower incidence of COVID-19 related hospitalizations and death in the combination therapy arm compared with the placebo group (4 events vs 15 events), corresponding to an 87% risk reduction (P <.0001). Treatment with the combination therapy was also associated with statistically significant improvements on key secondary end points, including viral load reductions.
The safety profile of bamlanivimab with etesevimab was consistent with that seen in previous studies. There were 4 COVID-19 related deaths reported in the placebo arm and no deaths in the combination therapy arm. Based on data from the two phase 3 cohorts of BLAZE-1, there have been no deaths reported in patients treated with combination therapy and 14 deaths in patients treated with placebo.
“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, MD, PhD, Lilly’s chief scientific officer and president of Lilly Research Laboratories.
Findings from this new phase 3 cohort were consistent with those previously reported in other data sets from BLAZE-1. In January 2021, Lilly announced results from a phase 3 cohort that demonstrated a 70% risk reduction in hospitalizations and death with bamlanivimab 2800mg plus etesevimab 2800mg. Moreover, in a phase 2 cohort, bamlanivimab alone reduced the risk of hospitalizations and ER visits by approximately 70%.
Lilly’s bamlanivimab and etesevimab together reduced hospitalizations and death in phase 3 trial for early COVID-19. [press release]. Indianapolis, IN: Eli Lilly and Company; March 10, 2021.