New data suggests that the antibody cocktail, bamlanivimab plus etesevimab, reduces the risk of COVID-19-related hospitalizations and death by 87% in high-risk COVID-19 patients.
New data from the BLAZE-1 phase 3 clinical trial suggests that treatment with the SARS-CoV-2 neutralizing antibodies bamlanivimab plus etesevimab (Eli Lilly and Company) significantly reduced the risk of COVID-19-related hospitalization and mortality in high-risk patients recently diagnosed with COVID-19.
BLAZE-1 is a randomized, double-blind, placebo-controlled phase 2/3 study designed to assess the efficacy and safety of bamlanivimab alone or bamlanivimab plus etesevimab for the treatment of symptomatic COVID-19 in the outpatient setting.
Eli Lilly announced the new results from the phase 3 portion of BLAZE-1 in a March 10, 2021 press release. In phase 3, researchers evaluated the combination therapy in a new cohort which included 769 high-risk patients, aged ≥12 years with mild-to-moderate COVID-19.
Patients were randomly assigned 2:1 to receive bamlanivimab 700 mg plus etesevimab 1400 mg (n=511) or placebo (n=258).
Results showed a significantly lower incidence of COVID-19-related hospitalizations and mortality in the combination therapy group vs the placebo group (4 events vs 15 events), corresponding to an 87% risk reduction (P<.0001). Treatment with bamlanivimab plus etesevimab demonstrated statistically significant improvements on key secondary end points, including viral load reductions.
These results are consistent with those reported in previous data sets from BLAZE-1. In a January 2021 press release, Eli Lilly announced results from a phase 3 cohort that showed a 70% risk reduction in COVID-19-related hospitalizations and death with bamlanivimab 2800 mg plus etesevimab 2800 mg. In addition, a phase 2 cohort showed bamlanivimab alone reduced the risk of hospitalizations and emergency room visits by approximately 70%.
The safety profile of the combination therapy was also consistent with that seen in previous studies. There were 4 COVID-19-related deaths reported in the placebo group and no deaths in the combination therapy group. In the 2 phase 3 cohorts that have been analyzed to date, there were no deaths reported in the combination therapy cohort vs 14 deaths in the placebo cohort.
“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, chief scientific officer, Eli Lilly and Company, president, Lilly Research Laboratories, in the company press release.