Eli Lilly has announced that its monoclonal antibody prevented COVID-19 infections in nursing home residents and staff in a clinical trial, the first time such a treatment has been shown to prevent infection. Lilly released the results in a press release, although it said that it would publish the data in a research paper as quickly as possible.
Bamlanivimab significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities, Eli Lilly announced. The Phase 3 BLAZE-2 COVID-19 prevention trial – conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the COVID-19 Prevention Network (CoVPN) – enrolled residents and staff at skilled nursing and assisted living facilities, commonly referred to as nursing homes, across the US.
The 965 participants who tested negative for the SARS-CoV-2 virus at baseline (299 residents and 666 staff) were included in the analysis of primary and key secondary endpoints for assessing prevention, while the 132 participants (41 residents and 91 staff) who tested positive for the virus at baseline were included in exploratory analyses for assessing treatment, adding to the growing body of evidence for treatment with bamlanivimab. All participants were randomized to receive either 4,200 mg of bamlanivimab or placebo.
After all participants reached 8 weeks of follow-up, there was a significantly lower frequency of symptomatic COVID-19 (the primary endpoint) in the bamlanivimab treatment arm versus placebo (odds ratio 0.43, p=0.00021). Results for all key secondary endpoints also reached statistical significance in both the overall and resident populations.
For the pre-specified subgroup of nursing home residents, there was also a significantly lower frequency of symptomatic COVID-19 in those treated with bamlanivimab versus placebo in this important population (odds ratio 0.20; p=0.00026). These results suggest that residents randomized to bamlanivimab have up to an 80% lower risk of contracting COVID-19 versus residents in the same facility randomised to placebo.
Results from exploratory analyses of viral load in the treatment group were consistent with previously disclosed data from BLAZE-1 evaluating bamlanivimab as an outpatient treatment for recently diagnosed COVID-19.
Among the 299 residents in the prevention group, there were 4 deaths attributed to COVID-19 at the time of death, and all occurred in the placebo arm. There were no COVID-19 attributed deaths in the bamlanivimab arm. Among the 41 residents in the treatment group, there were 4 deaths, and all occurred in the placebo arm with none in the bamlanivimab arm. Over the entire trial, there were a total of 16 deaths reported, including deaths not related to COVID-19, and all deaths were residents (11 deaths in placebo arm and 5 in bamlanivimab arm).
"We are exceptionally pleased with these positive results, which showed bamlanivimab was able to help prevent COVID-19, substantially reducing symptomatic disease among nursing home residents, some of the most vulnerable members of our society," said Dr Daniel Skovronsky, Lilly's chief scientific officer and president of Lilly Research Laboratories.
"These data provide important additional clinical evidence regarding the use of bamlanivimab to fight COVID-19 and strengthen our conviction that monoclonal antibodies such as bamlanivimab can play a critical role in turning the tide of this pandemic. We're glad bamlanivimab is already available as a treatment for patients at high risk for progressing to severe COVID-19 illness or hospitalisation, including those in nursing homes, and look forward to working with regulators to explore expanding the emergency use authorisation to prevent the spread of COVID-19 in these facilities."
An independent data and safety monitoring board oversaw the BLAZE-2 trial. In the trial, the safety profile of bamlanivimab was consistent with observations from the Phase 1 and Phase 2 trials. Serious adverse events were reported at a similar frequency in the bamlanivimab and placebo groups. Across multiple clinical trials, Lilly now has collected safety and efficacy data in more than 4,000 patients treated with bamlanivimab, either alone or administered together with another antibody.
"The results of this innovative study further support the belief that bamlanivimab – and potentially other monoclonal antibodies – can reduce symptoms and may even prevent COVID-19," said Dr Myron S Cohen, CoVPN co-principal investigator and director of the Institute for Global Health and Infectious Diseases at the University of North Carolina at Chapel Hill. "The antiviral activity seen with bamlanivimab treatment emphasizes the importance of early intervention to help counter the devastating impact the virus has had in this vulnerable population and other high-risk patients."
BLAZE-2 is a first-of-its-kind COVID-19 trial designed to evaluate this vulnerable population by addressing the challenging aspects of running a clinical trial in long-term care facilities, which normally do not conduct clinical trials.
The study is sponsored by Lilly and conducted in partnership with NIAID, part of the NIH, along with the CoVPN and numerous long-term care facility networks across the country. BLAZE-2 is ongoing as an open-label trial evaluating bamlanivimab alone or administered together with another antibody as a treatment for high-risk individuals (residents and staff) diagnosed with COVID-19 at these long-term care facilities.
The full results from BLAZE-2 will be presented at a future medical congress and submitted for publication in a peer-reviewed clinical journal.
Bamlanivimab is authorised for emergency use by the US Food and Drug Administration for the treatment of mild to moderate COVID-19 in high-risk patients.
The New York Times reports that the research ended with an emergency meeting of the data safety and monitoring board, an independent group monitoring the incoming results. The data were strong and convincing enough to call a halt to the placebos.
“My jaw dropped when I saw the table of outcomes,” said Cohen.
Although the study has ended, Skovronsky said the company would continue to rush to nursing homes in its study network when an outbreak is detected. “Everyone will get the drug,” he said.
The report said experts who were not part of the study were enthusiastic, but emphasized that they had not yet seen complete data. “I see only positives here,” said Dr Ofer Levy, director of the precision vaccine programme at Boston Children’s Hospital. “This is a win.”
Dr Kathleen Neuzil, director of the Centre for Vaccine Development and Global Health at the University of Maryland School of Medicine, also was encouraged.
“The mortality effect is remarkable,” she said, adding that the drug should be used more widely to prevent and treat COVID-19, “particularly in populations such as nursing home residents, who have high mortality and may have suboptimal responses to vaccines.”
[link url="https://investor.lilly.com/news-releases/news-release-details/lillys-neutralizing-antibody-bamlanivimab-ly-cov555-prevented"]Eli Lilly material[/link]
[link url="https://www.nytimes.com/2021/01/21/health/coronavirus-eli-lilly.html"]Full report in The New York Times (Open access)[/link]