New data show treatment with Lilly's neutralizing antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) together reduced risk of COVID-19 hospitalizations and death by 70 per cent
- BLAZE-1 trial met primary endpoint and key secondary endpoints with high statistical significance
- Results from more than 1,000 high-risk patients were consistent with previous data
- Findings from BLAZE-4 trial provide data on lower doses of bamlanivimab and etesevimab together
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Bamlanivimab and etesevimab together also demonstrated statistically significant improvements on all key secondary endpoints, providing strong evidence that the therapy reduced viral load and accelerated symptom resolution.
"These data show that treatment with bamlanivimab and etesevimab together may be effective in reducing symptoms, reducing viral load, and decreasing the risk of hospitalization and death in patients recently diagnosed with mild to moderate COVID-19," said
"Notably, the 70 per cent decrease in risk of hospitalizations or death seen in this Phase 3 trial of bamlanivimab and etesevimab together is consistent with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone in the Phase 2 trial," said
In the trial, the safety profile of bamlanivimab and etesevimab together was consistent with observations from other Phase 1, Phase 2 and Phase 3 trials evaluating these antibodies. Serious adverse events were reported at a similar frequency in the group receiving bamlanivimab and etesevimab together and the group receiving placebo. Across multiple clinical trials,
Bamlanivimab is authorized for use in the treatment of mild- to moderate COVID-19 in high-risk patients under
Additionally, initial results from the ongoing BLAZE-4 trial provide viral load and pharmacodynamic/pharmacokinetic data which demonstrated lower doses, including bamlanivimab 700 mg and etesevimab 1400 mg together, are similar to bamlanivimab 2800 mg and etesevimab 2800 mg together.
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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 COVID19 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
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 (
Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. Bamlanivimab emerged from the collaboration between
Etesevimab (LY-CoV016, also known as JS016) is a recombinant fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function.
BLAZE-1 (NCT04427501) is a randomized, double-blind, placebo-controlled Phase 2/3 study designed to assess the efficacy and safety of bamlanivimab alone or bamlanivimab and etesevimab together for the treatment of symptomatic COVID-19 in the outpatient setting. To be eligible, patients were required to have mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than three days prior to drug infusion.
In the Phase 2 portion of BLAZE-1, cohorts of mild to moderate recently diagnosed COVID-19 patients, were randomized to one of three doses of bamlanivimab (700 mg, 2800 mg, and 7000 mg), bamlanivimab 2800 mg plus etesevimab 2800 mg, or placebo. Results from the Phase 2 cohorts of BLAZE-1 were published in the
In the Phase 3 portion of BLAZE-1, the combination therapy arms enrolled mild to moderate, recently diagnosed COVID-19 patients who are at high risk for progressing to severe COVID-19 and/or hospitalization, studying bamlanivimab 2800 mg plus etesevimab 2800 mg versus placebo. The primary outcome measure for the Phase 3 portion of the BLAZE-1 trial was the percentage of participants who experience COVID-related hospitalizations or death from any cause by day 29. The key secondary endpoints were change from baseline to day 7 in SARS-CoV-2 viral load, persistently high SARS-CoV2 viral load on day 7, time to sustained symptom resolution, and COVID-related hospitalization, ER visit or death from any cause from baseline by day 29. Additional endpoints include change from baseline in viral load at other time points, symptom improvement, symptom resolution, as well as safety.
The study is ongoing with additional treatment arms. Across all treatment arms, the trial will enroll up to 3,300 participants.
BLAZE-4 (NCT04634409) is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of bamlanivimab alone, and bamlanivimab and etesevimab together, at various doses, versus placebo for the treatment of symptomatic COVID-19 in the outpatient setting. Across all treatment arms, the trial will enroll an estimated 1,000 participants in
The primary outcome measure is percentage of participants who have a viral load greater than 5.27 at day 7. Additional endpoints include change from baseline to Day 7 in SARS-CoV-2 viral load, percentage of participants who experience COVID-related hospitalization, ER visit or death from baseline through Day 29, as well as safety.
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Lilly Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about bamlanivimab (LY-CoV555) as a potential treatment for patients with or at risk of infection from COVID-19, as well as its supply, and reflects