bamlanivimab and etesevimab together

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What was the effect of bamlanivimab and etesevimab together treatment on preventing hospitalization and deaths?

Patients treated with bamlanivimab 700 mg and etesevimab 1400 mg had an 87% reduction in COVID-related hospitalizations or death of any cause relative to placebo.

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Bamlanivimab and Etesevimab Emergency Use Authorization

Bamlanivimab and etesevimab have not been approved, but have only been authorized for emergency use by FDA to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.1,2

Bamlanivimab and etesevimab are authorized to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the bamlanivimab and etesevimab under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.1,2

For information on the authorized use of bamlanivimab and etesevimab together and mandatory requirements under the EUA, please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients/Caregivers at www.LillyAntibody.com.

Bamlanivimab and etesevimab are not authorized for use in states, territories, and US jurisdictions in which the combined frequency of variants resistant to bamlanivimab and etesevimab exceeds 5%, as determined by FDA. A list of states, territories, and US jurisdictions in which bamlanivimab and etesevimab are and are not currently authorized is available on the following FDA website: https://www.fda.gov/media/151719/download .1,2

Bamlanivimab and Etesevimab Available Clinical Data

The information presented in the sections below contain data on unauthorized doses of bamlanivimab and etesevimab administered together. The only authorized dose of bamlanivimab and etesevimab administered together for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) is bamlanivimab 700 mg and etesevimab 1400 mg.

BLAZE-1 Clinical Trial Design

BLAZE-1 is an ongoing phase randomized, double-blind, placebo-controlled trial evaluating bamlanivimab and etesevimab together, in non-hospitalized patients with mild to moderate COVID-19.3,4

BLAZE Clinical Trial Designs provides a summary of the BLAZE-1 clinical trial design.

BLAZEa Clinical Trial Designs1,4,5

 

BLAZE-1 Phase 3 (NCT04427501)

Design

Randomized, double-blind, placebo-controlled trial in non-hospitalized patients with mild to moderate COVID-19 and at least 1 risk factorb for developing severe COVID-19 illness

Primary Endpoint

Percentage of participants who experience COVID-related hospitalization or death through day 29.

Treatment arms included in analyses

Patients randomized to IV infusion of

  • bamlanivimab 2800 mg and etesevimab 2800 mg together (n=518), or
  • placebo (n=517)

Patients randomized to IV infusion of

  • bamlanivimab 700 mg and etesevimab 1400 mg together (n=511), or
  • placebo (n=258)

Abbreviations: BAM = bamlanivimab; BMI = body mass index; CKD = chronic kidney disease; COPD = chronic obstructive pulmonary disease; COVID-19 = coronavirus disease 2019; CVD = cardiovascular disease; ETE = etesevimab; IV = intravenous.

aBLAZE clinical trials are ongoing studies, outcomes measures, inclusion/exclusion criteria, and eligibility may change throughout the study.

bRisk factors include: ≥ 65 years of age, BMI ≥ 35, CKD, type 1 or type 2 diabetes, immunosuppressive disease, receiving immunosuppressive treatment; ≥ 55 years of age AND have a history of CVD, or hypertension, or COPD or other chronic respiratory disease; 12-17 years of age AND satisfy at least one of the following at the time of screening: BMI ≥85th percentile for their age and gender based on CDC growth charts, sickle cell disease, congenital or acquired heart disease, neurodevelopmental disorders (for example, cerebral palsy), medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation not related to COVID-19), asthma or reactive airway or other chronic respiratory disease, type 1 or type 2 diabetes, immunosuppressive disease, or currently receiving immunosuppressive treatment.

Results With Bamlanivimab and Etesevimab Treatment

Authorized Dose

The dosage of bamlanivimab and etesevimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) is

  • bamlanivimab 700 mg, and
  • etesevimab 1400mg.1 

Baseline Demographics

Baseline demographics and disease characteristics were well balanced across treatment groups for each of the studies.1BLAZE Clinical Trials Baseline Demographics and Disease Characteristics provides information by study.

BLAZE Clinical Trials Baseline Demographics and Disease Characteristics1,6


BLAZE-1 Phase 3

BLAZE-1 Phase 3

Included treatment arms

  • BAM 2800 mg + ETE 2800 mg 
  • Placebo
  • BAM 700 mg + ETE 1400 mg
  • Placebo

Total N

N=1035

N=769

Median age, years

56

56

≥ 65 years old

31%

30%

Female

52%

53%

White

87%

87%

Hispanic or Latino

29%

27%

Black or African American

8%

8%

High-riska for severe COVID-19 illness

100% 

99.2%

Mild COVID-19

77%

76%

Moderate COVID-19

23%

24%

Mean duration of symptoms, days

4

4

Mean viral load by CT

24

24

Abbreviations: BAM = bamlanivimab; BMI = body mass index; CKD = chronic kidney disease; COVID-19 = coronavirus disease 2019; CT = cycle threshold; CVD = cardiovascular disease; ETE = etesevimab.

aHigh-risk criteria was defined as adults (≥18 years of age) with at least one of the following: age ≥65 years, BMI ≥35, CKD, diabetes, immunosuppressive disease, immunosuppressant treatment, or age ≥55 years with CVD, hypertension, chronic pulmonary disease or other chronic respiratory disease. Participants ages 12-17 were also enrolled in the trial and met high-risk criteria as defined in the trial protocol. 

BLAZE-1 Phase 3: Hospitalizations or Deaths

In the phase 3 portion of the BLAZE-1 trial, >99% of patients enrolled in these dose arms met the criteria for high-risk. Patients were treated with a single IV infusion of

  • bamlanivimab 700 mg and etesevimab 1400 mg (N=511)
  • bamlanivimab 2800 mg and etesevimab 2800 mg (N=518), or
  • placebo.1

In the phase 3 portion of the BLAZE-1 study, the primary endpoint was the number of COVID-19 related hospitalizations (defined as ≥24 hours of acute care) or death by any cause by Day 29.1

Compared to placebo, there were significantly less hospitalizations or deaths in patients treated with bamlanivimab and etesevimab together (p<.001). See full details in  Hospitalizations or Deaths by Day 29 in BLAZE-1 Phase 3.1

 Hospitalizations or Deaths by Day 29 in BLAZE-1 Phase 31

 

Placebo
N=258

BAM 700 mg
+ ETE 1400 mg
N=511

Placebo
N=517

BAM 2800 mg
+ ETE 2800 mg
N=518

Hospitalizations or deaths, n (%)a

15 (6%)

4 (0.8%)

36 (7%)

11 (2%)

% reduction vs placebo

87%

70%

p-value vs placebo

<.0001

<.001

Abbreviations: BAM = bamlanivimab; ETE = etesevimab

aIncludes hospitalizations defined as ≥24 hours of acute care or death by any cause by Day 29.

Hospitalizations

Details related to hospitalizations are presented in  BLAZE-1 Phase 3 Hospitalizations.

 BLAZE-1 Phase 3 Hospitalizations6

 

Placebo
N=258

BAM 700 mg + ETE 1400 mg
N=511

Placebo
N=517

BAM 2800 mg + ETE 2800 mg
N=518

Hospitalizations, n (%)a

14 (5.4)

4 (0.8)

33 (6)

11 (2)

Duration of hospitalizations, mean days (SD)
[Min, Max]

13.5 (7.5)
[4, 24]

7.3 (3.3)
[4, 11]

11.2 (10.1)
[1, 41]

7.3 (6.4)
[1, 25]

RRR

-

86%

-

68%b

ARR

-

4.6%

-

4.5%b

NNT

-

22

-

22

Abbreviations: ARR = absolute risk reduction; BAM = bamlanivimab; ETE = etesevimab; Max = maximum; Min = minimum; NNT = number needed to treat; RRR = relative risk reduction.

aDefined as ≥24 hours of acute care.

bCalculation based on n=34 events in placebo group that included a recorded hospitalization in a patient with missing duration information.

Deaths 

In the BLAZE-1 trial there were

  • no deaths in patients treated with bamlanivimab and etesevimab, and 
  • 14 deaths in patients treated with placebo.1

All deaths occurred in the BLAZE-1 phase 3 portion of the study.1

Based on phase 3 analyses the NNT by treatment dose for COVID-19 related deaths is

  • 58 for bamlanivimab 2800 mg and etesevimab 2800 mg vs placebo, and 
  • 60 for bamlanivimab 700 mg and etesevimab 1400 mg vs placebo.6

Reference

The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).

1Fact sheet for healthcare providers. Emergency Use Authorization (EUA) of bamlanivimab and etesevimab. US Food and Drug Administration (FDA). 2021.

2United States Food and Drug Administration. Bamlanivimab and Etesevimab FDA Emergency Use Authorization Letter. Issued August 27, 2021. Accessed August 27, 2021. http://pi.lilly.com/eua/bam-and-ete-eua-fda-authorization-letter.pdf

3A study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in participants with mild to moderate COVID-19 illness (BLAZE-1). ClinicalTrials.gov identifier: NCT04427501. Updated January 27, 2021. Accessed January 27, 2021. https://www.clinicaltrials.gov/ct2/show/NCT04427501

4Gottlieb RL, Nirula A, Chen P, et al. Effect of bamlanivimab as monotherapy or in combination with etesevimab on viral load in patients with mild to moderate COVID-19: a randomized clinical trial. JAMA. 2021;325(7):632-644. http://dx.doi.org/10.1001/jama.2021.0202

5A study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in participants with mild to moderate COVID-19 illness (BLAZE-1). ClinicalTrials.gov identifier: NCT04427501. Updated April 20, 2021. Accessed April 22, 2021. https://www.clinicaltrials.gov/ct2/show/NCT04427501

6Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

ASPR = Assistant Secretary for Preparedness and Response

COVID-19 = coronavirus disease 2019

EUA = emergency use authorization

FDA = Food and Drug Administration

IV = intravenous

SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2

US = United States

Date of Last Review: May 14, 2021


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