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All Studies   Meta Analysis    Recent:   

Bebtelovimab, alone or together with bamlanivimab and etesevimab, as a broadly neutralizing monoclonal antibody treatment for mild to moderate, ambulatory COVID-19

Dougan et al., medRxiv, doi:10.1101/2022.03.10.22272100, BLAZE-4, NCT04634409
Mar 2022  
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0 0.5 1 1.5 2+ Hospitalization -51% Improvement Relative Risk Recovery time 12% no CI Viral load reduction, day 7 9% Viral load reduction, day 5 24% Viral load reduction, day 3 12% Viral clearance 35% primary Bamlanivimab/e..  BLAZE-4  EARLY TREATMENT  RCT Is early treatment with bamlan../e.. + bebtelovimab beneficial for COVID-19? RCT 714 patients in the USA (April - July 2021) Improved viral clearance with bamlan../e.. + bebtelovimab (p<0.000001) c19early.org Dougan et al., medRxiv, March 2022 Favors bamlanivimab/e.. Favors control
20th treatment shown to reduce risk in May 2021
 
*, now known with p = 0.00029 from 20 studies, recognized in 7 countries. Efficacy is variant dependent.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,200+ studies for 70+ treatments. c19early.org
RCT showing improved viral clearance with bamlanivimab/etesevimab combined with bebtelovimab. Results refer to the placebo controlled portion of the trial.
Efficacy is highly variant dependent. In Vitro research suggests a lack of efficacy for omicron1-5.
Study covers bamlanivimab/etesevimab and bebtelovimab.
risk of hospitalization, 51.2% higher, RR 1.51, p = 0.68, treatment 3 of 127 (2.4%), control 2 of 128 (1.6%).
recovery time, 12.5% lower, relative time 0.88, treatment 127, control 128.
relative viral load reduction, 9.5% better, RR 0.91, p < 0.001, treatment mean 4.0 (±0.2) n=125, control mean 3.62 (±0.2) n=128, day 7.
relative viral load reduction, 24.2% better, RR 0.76, p < 0.001, treatment mean 2.81 (±0.19) n=125, control mean 2.13 (±0.19) n=128, day 5.
relative viral load reduction, 12.3% better, RR 0.88, p < 0.001, treatment mean 1.38 (±0.2) n=125, control mean 1.21 (±0.2) n=128, day 3.
risk of no viral clearance, 35.5% lower, RR 0.65, p = 0.17, treatment 16 of 127 (12.6%), control 25 of 128 (19.5%), NNT 14, persistently high viral load, day 7, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Dougan et al., 12 Mar 2022, Randomized Controlled Trial, USA, preprint, 22 authors, study period 19 April, 2021 - 19 July, 2021, this trial uses multiple treatments in the treatment arm (combined with bebtelovimab) - results of individual treatments may vary, trial NCT04634409 (history) (BLAZE-4). Contact: robert.gottlieb@bswhealth.org.
This PaperBamlaniv../e..All
Abstract: medRxiv preprint doi: https://doi.org/10.1101/2022.03.10.22272100; this version posted March 12, 2022. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . Bebtelovimab, alone or together with bamlanivimab and etesevimab, as a broadly neutralizing monoclonal antibody treatment for mild to moderate, ambulatory COVID-19. Authors: Michael Dougan, MD, PhD1; Masoud Azizad, MD2, Peter Chen, MD3; Barry Feldman, MD4; Matthew Frieman, PhD5; Awawu Igbinadolor, MD6; Princy Kumar, MD7; Jason Morris, MD8; Jeffrey Potts, MD9; Lauren Baracco, BS5; Lisa Macpherson, MSPHc10; Nicole L. Kallewaard, PhD10; Dipak R. Patel, MD, PhD10; Matthew M. Hufford, PhD10; Linda Wietecha, MSc10; Emmanuel Chigutsa, PhD10; Sarah L. Demmon, MS10; Bryan E. Jones, PhD10; Ajay Nirula, MD, PhD10; Daniel M. Skovronsky, MD, PhD10; Mark Williams, MD, FCCM, FCCP10; Robert L. Gottlieb, MD, PhD11. Affiliations: 1Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; 2Valley Clinical Trials, Northridge, CA, USA; 3Cedars–Sinai Medical Center, Los Angeles, CA, USA; 4Millennium Medical Group, Farmington Hills, MI, USA; 5University of Maryland School of Medicine, Baltimore, MD; 6Monroe Biomedical Research, Monroe, NC, USA; 7Georgetown University, Washington, DC, USA; 8Clinical Trials of Southwest Louisiana, Lake Charles, LA, USA; 9Great Lakes Research Group, Inc., Bay City, MI, USA; 10Eli Lilly and Company, Indianapolis, IN, USA. 11Baylor University Medical Center and Baylor Scott & White Research Institute, Dallas, TX, USA; Corresponding author: Robert L. Gottlieb, MD, PhD, Baylor University Medical Center and Baylor Scott & White Research Institute, Dallas, TX, USA. E-mail: Robert.Gottlieb@BSWHealth.org. Phone: +1-214-820-6856 (Office). NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. 1 medRxiv preprint doi: https://doi.org/10.1101/2022.03.10.22272100; this version posted March 12, 2022. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . BACKGROUND: Bebtelovimab is a potent, fully human IgG1 monoclonal antibody (mAb) targeting the S-protein of SARS-CoV-2, with broad neutralizing activity to all currently known SARS-CoV-2 variants of concern, including omicron variant lineages. Specialized developmental approaches accelerated the initiation of a clinical trial designed to evaluate the efficacy and safety of bebtelovimab alone (BEB) or together with bamlanivimab (BAM) and etesevimab (ETE) delivered via slow intravenous push for the treatment of mild-tomoderate COVID-19. METHODS: This portion of the phase 2, BLAZE-4 trial (J2X-MC-PYAH; NCT04634409) enrolled 714 patients (between May and July 2021) with mild-to-moderate COVID-19 within 3 days (≤3 days) of laboratory diagnosis of SARS-CoV-2 infection. Patients at low risk for severe COVID19 were randomized 1:1:1 (double-blinded) to placebo, BEB 175 mg, or BEB 175 mg+BAM 700 mg+ETE 1400 mg (BEB+BAM+ETE). Patients at high risk for progression to severe COVID-19 were randomized 2:1 (open-label) to BEB or BEB+BAM+ETE, and a subsequent treatment arm enrolled..
{ 'institution': [{'name': 'medRxiv'}], 'indexed': {'date-parts': [[2023, 4, 20]], 'date-time': '2023-04-20T06:19:57Z', 'timestamp': 1681971597955}, 'posted': {'date-parts': [[2022, 3, 12]]}, 'group-title': 'Infectious Diseases (except HIV/AIDS)', 'reference-count': 29, 'publisher': 'Cold Spring Harbor Laboratory', 'content-domain': {'domain': [], 'crossmark-restriction': False}, 'accepted': {'date-parts': [[2022, 3, 12]]}, 'abstract': '<jats:sec><jats:title>BACKGROUND</jats:title><jats:p>Bebtelovimab is a potent, fully human ' 'IgG1 monoclonal antibody (mAb) targeting the S-protein of SARS-CoV-2, with broad neutralizing ' 'activity to all currently known SARS-CoV-2 variants of concern, including omicron variant ' 'lineages. Specialized developmental approaches accelerated the initiation of a clinical trial ' 'designed to evaluate the efficacy and safety of bebtelovimab alone (BEB) or together with ' 'bamlanivimab (BAM) and etesevimab (ETE) delivered via slow intravenous push for the treatment ' 'of mild-to-moderate ' 'COVID-19.</jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p>This portion ' 'of the phase 2, BLAZE-4 trial (J2X-MC-PYAH; <jats:ext-link ' 'xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" ' 'xlink:href="NCT04634409">NCT04634409</jats:ext-link>) enrolled 714 patients (between May and ' 'July 2021) with mild-to-moderate COVID-19 within 3 days (≤3 days) of laboratory diagnosis of ' 'SARS-CoV-2 infection. Patients at low risk for severe COVID-19 were randomized 1:1:1 ' '(double-blinded) to placebo, BEB 175 mg, or BEB 175 mg+BAM 700 mg+ETE 1400 mg (BEB+BAM+ETE). ' 'Patients at high risk for progression to severe COVID-19 were randomized 2:1 (open-label) to ' 'BEB or BEB+BAM+ETE, and a subsequent treatment arm enrolled patients to BEB+BAM+ETE using ' 'Centers for Disease Control and Prevention (CDC) updated criteria for High-risk. All ' 'treatments were administered intravenously over ≥30 seconds (open-label BEB) or ≥6.5 minutes ' '(all other treatment arms). For the placebo-controlled patients (termed Low-risk), the ' 'primary endpoint was the proportion of patients with persistently high viral load (PHVL) (log ' 'viral load &gt;5.27) on Day 7. For the open-label patients (termed High-risk), the primary ' 'endpoint was safety. In nonclinical studies, SARS-CoV-2 isolates were tested using an ' 'endpoint neutralization assay to measure BEB’s inhibitory concentration greater than 99% ' '(IC<jats:sub>99</jats:sub>).</jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p>Baseline ' 'viral sequencing data were available from 611 patients; 90.2% (n=551) aligned with a variant ' 'of interest or concern (WHO designation), with the majority infected with delta (49.8%) or ' 'alpha (28.6%) variants. Among the Low-risk patients, PHVL occurred in 19.8% of patients ' 'treated with placebo, as compared to 12.7% (p=0.132) of patients treated with BEB+BAM+ETE and ' '12.0% (p=0.097) of patients treated with BEB, a 36% and 40% relative risk reduction, ' 'respectively. Viral load-area under the curve analysis from baseline to Day 11 showed ' 'statistically signficant reductions for patients treated with BEB (p=0.006) and BEB+BAM+ETE ' '(p=0.043) compared to patients who received placebo. Time to sustained symptom resolution was ' 'reduced by a median of 2 days for patients treated with BEB (6 days; p=0.003) and 1 day for ' 'patients treated with BEB+BAM+ETE (7 days; p=0.289) compared to placebo (8 days). The ' 'incidence of COVID-19-related hospitalization or all-cause deaths by day 29 were similar ' 'across treatment arms, as expected given the patients’ risk status (the Low risk cohorts had ' 'a Low risk of hospitalization, and High risk cohorts received only active therapy without ' 'placebo). Overall, safety results were consistent with previous studies investigating mAbs ' 'targeting SARS-CoV-2. The proportion of patients with treatment emergent adverse events (AEs) ' 'were 9.7% in Low-risk (n=37/380) and 14.7% in High-risk (n=48/326) patients treated with BEB ' 'or BEB+BAM+ETE; majority of AEs were considered mild or moderate in severity. Serious AEs ' 'were reported in 2.1% of High-risk patients (n=7/326), including one death (a cerebrovascular ' 'accident); 1 serious AE was reported among Low-risk patients. In an in vitro neutralization ' 'assay, BEB neutralized the omicron isolate (BA.1) with &lt;2.44ng/ml estimated ' 'IC<jats:sub>99</jats:sub>.</jats:p></jats:sec><jats:sec><jats:title>CONCLUSIONS</jats:title><jats:p>In ' 'patients with mild-to-moderate COVID-19, treatment with BEB or BEB+BAM+ETE was associated ' 'with greater viral clearance, a reduction in time to sustained symptom resolution, and safety ' 'results consistent with mAbs that target SARS-CoV-2. Integration of clinical findings with in ' 'vitro neutralization of emerging viral variants offered a pragmatic framework for ' 'investigating the efficacy of a new antiviral mAb agent, as demonstrated by ' 'bebtelovimab.</jats:p></jats:sec>', 'DOI': '10.1101/2022.03.10.22272100', 'type': 'posted-content', 'created': {'date-parts': [[2022, 3, 13]], 'date-time': '2022-03-13T06:50:11Z', 'timestamp': 1647154211000}, 'source': 'Crossref', 'is-referenced-by-count': 22, 'title': 'Bebtelovimab, alone or together with bamlanivimab and etesevimab, as a broadly neutralizing ' 'monoclonal antibody treatment for mild to moderate, ambulatory COVID-19', 'prefix': '10.1101', 'author': [ {'given': 'Michael', 'family': 'Dougan', 'sequence': 'first', 'affiliation': []}, {'given': 'Masoud', 'family': 'Azizad', 'sequence': 'additional', 'affiliation': []}, {'given': 'Peter', 'family': 'Chen', 'sequence': 'additional', 'affiliation': []}, {'given': 'Barry', 'family': 'Feldman', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0003-0107-0775', 'authenticated-orcid': False, 'given': 'Matthew', 'family': 'Frieman', 'sequence': 'additional', 'affiliation': []}, {'given': 'Awawu', 'family': 'Igbinadolor', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-5994-2727', 'authenticated-orcid': False, 'given': 'Princy', 'family': 'Kumar', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jason', 'family': 'Morris', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jeffrey', 'family': 'Potts', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0002-6984-5832', 'authenticated-orcid': False, 'given': 'Lauren', 'family': 'Baracco', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0003-3224-9233', 'authenticated-orcid': False, 'given': 'Lisa', 'family': 'Macpherson', 'sequence': 'additional', 'affiliation': []}, {'given': 'Nicole L.', 'family': 'Kallewaard', 'sequence': 'additional', 'affiliation': []}, {'given': 'Dipak R.', 'family': 'Patel', 'sequence': 'additional', 'affiliation': []}, {'given': 'Matthew M.', 'family': 'Hufford', 'sequence': 'additional', 'affiliation': []}, {'given': 'Linda', 'family': 'Wietecha', 'sequence': 'additional', 'affiliation': []}, {'given': 'Emmanuel', 'family': 'Chigutsa', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sarah L.', 'family': 'Demmon', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0003-4764-6290', 'authenticated-orcid': False, 'given': 'Bryan E.', 'family': 'Jones', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ajay', 'family': 'Nirula', 'sequence': 'additional', 'affiliation': []}, {'given': 'Daniel M.', 'family': 'Skovronsky', 'sequence': 'additional', 'affiliation': []}, {'given': 'Mark', 'family': 'Williams', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0001-8376-8709', 'authenticated-orcid': False, 'given': 'Robert L.', 'family': 'Gottlieb', 'sequence': 'additional', 'affiliation': []}], 'member': '246', 'reference': [ { 'key': '2022031421501172000_2022.03.10.22272100v1.1', 'unstructured': 'COVID-19 Weekly Epidemiological Update. [WHO] World Health Organization, ' '2022. (Accessed January 11, 2022., at ' 'https://www.who.int/publications/m/item/weekly-epidemiological-update-on-covid-1911-january-2022.)'}, { 'key': '2022031421501172000_2022.03.10.22272100v1.2', 'doi-asserted-by': 'crossref', 'first-page': '815', 'DOI': '10.1016/j.tips.2020.07.004', 'article-title': 'Fruitful Neutralizing Antibody Pipeline Brings Hope To Defeat ' 'SARS-Cov-2', 'volume': '41', 'year': '2020', 'journal-title': 'Trends in pharmacological sciences'}, { 'key': '2022031421501172000_2022.03.10.22272100v1.3', 'first-page': '10', 'article-title': 'Perspectives on monoclonal antibody therapy as potential therapeutic ' 'intervention for Coronavirus disease-19 (COVID-19)', 'volume': '38', 'year': '2020', 'journal-title': 'Asian Pacific journal of allergy and immunology'}, { 'key': '2022031421501172000_2022.03.10.22272100v1.4', 'doi-asserted-by': 'crossref', 'first-page': '382', 'DOI': '10.1038/s41577-021-00542-x', 'article-title': 'Neutralizing monoclonal antibodies for treatment of COVID-19', 'volume': '21', 'year': '2021', 'journal-title': 'Nat Rev Immunol'}, { 'key': '2022031421501172000_2022.03.10.22272100v1.5', 'doi-asserted-by': 'publisher', 'DOI': '10.1126/science.abb2762'}, { 'key': '2022031421501172000_2022.03.10.22272100v1.6', 'doi-asserted-by': 'publisher', 'DOI': '10.1016/j.cell.2020.05.034'}, { 'key': '2022031421501172000_2022.03.10.22272100v1.7', 'doi-asserted-by': 'publisher', 'DOI': '10.1038/nature02145'}, { 'key': '2022031421501172000_2022.03.10.22272100v1.8', 'doi-asserted-by': 'crossref', 'first-page': '327', 'DOI': '10.1038/s41586-020-2772-0', 'article-title': 'Receptor binding and priming of the spike protein of SARS-CoV-2 for ' 'membrane fusion', 'volume': '588', 'year': '2020', 'journal-title': 'Nature'}, { 'key': '2022031421501172000_2022.03.10.22272100v1.9', 'doi-asserted-by': 'crossref', 'first-page': '1382', 'DOI': '10.1056/NEJMoa2102685', 'article-title': 'Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19', 'volume': '385', 'year': '2021', 'journal-title': 'N Engl J Med'}, { 'key': '2022031421501172000_2022.03.10.22272100v1.10', 'doi-asserted-by': 'crossref', 'unstructured': 'Dougan M , Azizad M , Mocherla B , et al. 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