Lilly's neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80 per cent for residents
Bamlanivimab (LY-CoV555) significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities, Eli Lilly and Company (NYSE: LLY) announced. The Phase 3 BLAZE-2 COVID-19 prevention trial – conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), which is 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 U.S.
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 bamlanivimab as a preventative, while the 132 participants (41 residents and 91 staff) who tested positive for the virus at baseline were included in exploratory analyses for assessing bamlanivimab as a 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 occurrences 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 percent lower risk of contracting COVID-19 versus residents in the same facility randomized to placebo.
Results from exploratory analyses of viral load in the treatment group were consistent with previously disclosed data from BLAZE-1, which is 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 among residents (11 deaths in the placebo arm and 5 in the bamlanivimab arm).
"We're very pleased with these results, which showed bamlanivimab helped prevent COVID-19, and substantially reduced symptomatic disease among nursing home staff and residents," said Doron Sagman, M.D., FRCPC, Lilly Canada's senior medical director and vice president of R & D and Medical Affairs. "These data suggest that antibody therapy can help reduce mortality, keep people out of overcrowded hospitals, ease the current strain on the health care system, , and play an important role in helping fight the rapidly increasing burden of this global pandemic."
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 Myron S. Cohen, M.D., 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 devasting 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.
Important Information about bamlanivimab
HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS COVID-19 DRUG BASED ON LIMITED CLINICAL TESTING IN HUMANS AND/OR QUALITY INFORMATION.
Bamlanivimab is indicated for: The treatment of adults and pediatric patients 12 years of age or older with mild to moderate COVID-19 who weigh at least 40 kg and who are at high risk of progressing to severe COVID-19 illness and/or hospitalization.
The use of bamlanivimab is permitted under an interim authorization delivered in accordance with section 5 of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization. The interim authorization is associated with Terms and Conditions that need to be met by the sponsor to ascertain the continued quality, safety and efficacy of the product. For further information on authorization under this pathway, please refer to Health Canada's IO Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
Healthcare providers should review the product monograph for bamlanivimab, the Patient Medication Information on bamlanivimab, and the Dear HCP Letter on the use of bamlanivimab with English-only labels. Also available is the Bamlanivimab Playbook: information for provincial, territorial and local public health programs in planning and implementing the use of bamlanivimab in response to COVID-19 (December 2020).