Eli Lilly reported new phase 3 results demonstrating that the antibody cocktail containing bamlanivimab and etesevimab significantly reduced COVID-19-related hospitalizations and deaths in high-risk patients recently diagnosed with SARS-CoV-2 infection. “These positive results reinforce our previous findings and support the authorised dose,” remarked Daniel Skovronsky, president of Lilly Research Laboratories.
The antibody combination was authorized for emergency use in the US last month, at doses of 700 mg for bamlanivimab plus 1400 mg for etesevimab, to treat mild-to-moderate cases of COVID-19 in patients considered to be at high risk for progressing to severe disease. The regimen also recently gained a positive scientific opinion from the European Medicines Agency’s (EMA) advisory body. Those decisions were supported by Phase III data from the BLAZE-1 trial showing that the combination of bamlanivimab and etesevimab, each administered at 2800 mg doses, cut COVID-19-related hospitalizations and deaths by 70% in recently diagnosed patients. Early results from an ongoing Phase II study demonstrated bamlanivimab 700 mg and etesevimab 1400 mg together produced similar effects.
Authorised dose shows 87% risk reduction
According to Eli Lilly, a new BLAZE-1 cohort included 769 high-risk patients aged 12 and older with mild-to-moderate COVID-19, with 511 administered the combination of bamlanivimab 700 mg plus etesevimab 1400 mg, and 258 given placebo. Results showed that there were four events in patients taking the antibody cocktail and 15 events in the placebo group, representing an 87% risk reduction.
Eli Lilly also reported that there were a total of four deaths in this new phase 3 cohort, all considered related to COVID-19, and all of which occurred in the placebo group. When looking at the two BLAZE-1 cohorts that have been analyzed to date, the company noted that none of the patients treated with the antibody combination have died, whereas 14 deaths have been recorded among placebo subjects, with 13 of these thought to be related to COVID-19. Meanwhile, the safety profile of bamlanivimab plus etesevimab was consistent with observations from other trials evaluating the antibodies.
“I expect this [new] data to continue to drive more utilization of the antibodies” to treat COVID-19, said Skovronsky, adding “we have few other diseases where we have drugs that can offer this magnitude of benefit.” The US government agreed in February to purchase a minimum of 100,000 doses of the combination treatment for $210 million, with an option to buy up to an additional 1.1 million doses through November 25.
‘Combo covers all variants’
Skovronsky noted the results show the dual antibody regimen remains effective despite the recent concerning variants, and suggested Eli Lilly is “quite confident this combo covers all of the variants in the US.” He added the company is studying an additional treatment for new SARS-CoV-2 strains first identified in South Africa and Brazil, which have so far not become widespread in the US. The executive said Eli Lilly is prepared to manufacture 1 million doses of the combination therapy in the coming months and is negotiating supply deals with other countries as well.
Meanwhile, the US has already committed to purchase nearly 1.5 million doses of bamlanivimab alone, which has been authorized for emergency use in the US since November to treat mild-to-moderate COVID-19 in high-risk patients. The amount includes more than 1 million doses that have been delivered and an agreement to deliver 450,000 additional doses by March 31. The EMA’s Committee for Medicinal Products for Human Use has also issued a positive scientific opinion for use of bamlanivimab alone.