bamlanivimab and etesevimab together

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

In the BLAZE-1 study, a smaller percentage of bamlanivimab and etesevimab treated patients progressed to COVID-19 related hospitalizations or emergency room visits compared 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 progressing to severe COVID-19 and/or hospitalization.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 progressing to severe COVID-19 and/or hospitalization 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 BAMandETE.com.

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.

The EUA for bamlanivimab alone has been revoked by the US FDA as of April 16, 2021. Therefore, any information on bamlanivimab alone in the sections below is being provided for scientific and/or educational purposes, and is regarding an unauthorized and unapproved medication and dose. 

BLAZE-1 Clinical Trial Design

BLAZE-1 is a phase 2/3 randomized, double-blind, placebo-controlled trial evaluating bamlanivimab alone and together with etesevimab, in non-hospitalized patients with mild to moderate COVID-19.3,4

An estimated 3300 patients will be randomized to the following 3 treatment arms in the BLAZE-1 study:

  • bamlanivimab (700 mg, 2800 mg, and 7000 mg) IV infusion,
  • bamlanivimab (2800 mg) and etesevimab (2800 mg) IV infusion, or
  • placebo IV infusion.2-4

BLAZE Clinical Trial Designs provides a summary of the BLAZE-1 phase 2/3 clinical trial designs.

BLAZEa Clinical Trial Designs2-5

 

BLAZE-1 Phase 2 (NCT04427501)

BLAZE-1 Phase 3 (NCT04427501)

Design

Randomized, double-blind, placebo-controlled trial in non-hospitalized patients with mild to moderate COVID-19

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

Change from baseline to day 11 in SARS-CoV-2 viral load.

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 alone 700mg (n=101), 2800 mg (n=107), or 7000 mg (n=101)
  • bamlanivimab 2800 mg and etesevimab 2800 mg together (n=112), or
  • placebo (n=156)

Patients randomized to IV infusion of

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

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

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

Baseline Demographics

Baseline demographics and disease characteristics were well balanced across treatment groups for each of the studies.2BLAZE Clinical Trials Baseline Demographics and Disease Characteristics provides information by study.

BLAZE Clinical Trials Baseline Demographics and Disease Characteristics2

 

BLAZE-1 Phase 2

BLAZE-1 Phase 3

Median age, years

45

56

≥ 65 years old

12%

31%

Female

55%

52%

White

89%

87%

Hispanic or Latino

43%

29%

Black or African American

6%

8%

High-risk for severe COVID-19 illnessa

42%

100%

Mild COVID-19

78%

77%

Moderate COVID-19

22%

23%

Mean duration of symptoms, days

5 

4

Mean viral load by CT

24

24

Abbreviations: BMI = body mass index; CKD = chronic kidney disease; COVID-19 = coronavirus disease 2019; CT = cycle threshold.

aHigh risk is defined as patients who meet at least one of the following criteria: BMI ≥35, CKD, diabetes, immunosuppressive disease, receiving immunosuppressive treatment, ≥65 years old, ≥55 years old AND have cardiovascular disease, OR hypertension, OR chronic obstructive pulmonary disease/other chronic respiratory disease. Are 12 – 17 years of age AND have BMI ≥85th percentile for their age and gender based, OR sickle cell disease, OR congenital or acquired heart disease, OR neurodevelopmental disorders, OR a medical-related technological dependence, OR asthma, reactive airway or other chronic respiratory disease that requires daily medication for control.

BLAZE-1 Phase 2: Hospitalization and Emergency Department Visit Interim Results

In the phase 2 portion of the BLAZE-1 study, patients were treated with a single infusion of

  • bamlanivimab and etesevimab together (2800 mg each; N=112)
  • bamlanivimab alone (at doses of 700 mg [N=101], 2,800 mg [N=107], or 7,000 mg [N=101]), or
  • placebo (N=156).2

The data presented here are from an interim analysis after all enrolled patients completed at least Day 29 of the trial.2,4

Compared with placebo-treated participants, a lower proportion of bamlanivimab and etesevimab-treated participants progressed to COVID-19-related hospitalizations or emergency room visits. No deaths occurred in any treatment arm.2

Events of COVID-19-Related Hospitalizations or ER Visits in the BLAZE-1 Phase 2 Trial summarizes the rates of COVID-19 related hospitalizations and emergency room visits within 28 days after treatment in patients from the phase 2 portion of the BLAZE-1 trial.

Events of COVID-19-Related Hospitalizations or ER Visits in the BLAZE-1 Phase 2 Trial2,4,6

 

Hospitalizations
n 

ER Visits
n

All Events
n (%)

RRR

ARR

NNT

Placebo (N=156)

7

2

9 (6)

-

-

-

BAM + ETE Togethera (N=112)

0

1

1 (1)b

84.5%

4.9%

21

Bam 700 mg Alone (N=101)

1

0

1 (1) c

-

-

-

Abbreviations: ARR = absolute risk reduction; BAM = bamlanivimab; COVID-19 = coronavirus disease 2019; ETE = etesevimab; ER = emergency room; NNT = number needed to treat; RRR = relative risk reduction.

aBAM + ETE together includes data from the 2800 mg BAM + 2800 mg ETE treatment arm.

bp=.049 vs placebo

cp=.09 vs placebo

The length of hospitalization during the treatment period of the BLAZE-1 study included in the interim analysis, ranged from

  • 3-18 days in the placebo-treated patients, and
  • 2-8 days in the bamlanivimab-treated patients.6

There were no deaths in the BLAZE-1 phase 2 portion of the study in any of the treatment arms.2

Rate of Hospitalizations or Emergency Room Visits in High-Risk Patients

In the BLAZE-1 interim analyses, patients were considered to be at high risk if they had at least 1 of the following criteria

  • are ≥65 years of age
  • have a BMI ≥35
  • have chronic kidney disease
  • have diabetes
  • have immunosuppressive disease
  • are currently receiving immunosuppressive treatment
  • are ≥55 years of age and have
    • CVD, or
    • hypertension, or
    • COPD or other chronic respiratory disease.2

Events of COVID-19-Related Hospitalization or ER Visit at Any Time in High-Risk Patientssummarizes the events of hospitalization or emergency room visits in patients at higher risk of hospitalization in the phase 2 portion of the BLAZE-1 trial.

Events of COVID-19-Related Hospitalization or ER Visit at Any Time in High-Risk Patients2

Placebo
(N=68)

BAM + ETE Togethera
(N=38)

BAM 700 mg Aloneb
(N=46)

Events, n (%)

7 (10)

1 (3)

1 (2)

Abbreviations: BAM = bamlanivimab; COVID-19 = coronavirus disease 2019; ER = emergency room; ETE = etesevimab; N = number of treated patients in analysis .

aBAM + ETE together includes data from the 2800 mg BAM + 2800 mg ETE treatment arm.

bResults for other doses of bamlanivimab were suggestive of a flat dose-response relationship for this endpoint.

The absolute risk reduction for bamlanivimab and etesevimab-treated patients compared to placebo is greater in patients at higher risk of hospitalization according to the high risk criteria.2

There were no deaths in the BLAZE-1 phase 2 portion of the study in any of the treatment arms.

BLAZE-1 Phase 3: Hospitalizations or Deaths

In the phase 3 portion of the BLAZE-1 trial, patients were treated with a single infusion of bamlanivimab and etesevimab (2,800 mg each; N=518) or placebo (N=517). All of the patients enrolled in these dose arms met the criteria for high-risk.2

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 deaths by any cause by Day 29.2

Compared to placebo-treated patients (N=517), there was a 70% reduction in events of COVID-19 related hospitalization or death in patients treated with bamlanivimab and etesevimab treatment (2800 mg each; N=518), with

  • 36 (7%) events in patients treated with placebo, and
  • 11 (2%) events in patients treated with bamlanivimab and etesevimab together (p<.001 vs placebo).2

Hospitalizations

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

BLAZE-1 Phase 3 Hospitalizations6

 

Placebo
N=517

BAM 2800 mg + ETE 2800 mg
N=518

Hospitalizations, n (%)

33 (6)

11 (2)

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

11.2 (10.1)
[1, 41]

7.3 (6.4)
[1, 25]

Abbreviations: BAM = bamlanivimab; ETE = etesevimab; Max = maximum; Min = minimum.

COVID-Related Deaths

In the BLAZE-1 trial there were

  • no deaths in patients treated with bamlanivimab alone or bamlanivimab and etesevimab together (p<.001 vs placebo), and 
  • 10 deaths in patients treated with placebo. 2

All deaths occurred in the BLAZE-1 phase 3 portion of the study.2

Reference

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

1United States Food and Drug Administration. Bamlanivimab and Etesevimab FDA Emergency Use Authorization Letter. Issued February 9, 2021. Accessed February 9, 2021. http://pi.lilly.com/eua/bam-and-ete-eua-fda-authorization-letter.pdf

2Fact sheet for healthcare providers. Emergency Use Authorization (EUA) of bamlanivimab and etesevimab. US Food and Drug Administration (FDA). 2021.

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. JAMA. Published online January 21, 2021. http://dx.doi.org/10.1001/jama.2021.0202

5A study of immune system proteins in participants with mild to moderate COVID-19 illness (BLAZE-4). ClinicalTrials.gov identifier: NCT04634409. Updated January 22, 2021. Accessed January 27, 2021. https://clinicaltrials.gov/ct2/show/NCT04634409

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

Glossary

BMI = body mass index

COPD = chronic obstructive pulmonary disease

COVID-19 = coronavirus disease 2019

CVD = cardiovascular disease

EUA = emergency use authorization

FDA = Food and Drug Administration

IV = intravenous

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

Date of Last Review: March 30, 2021


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