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Bamlanivimab/etesevimab COVID-19 studies. Efficacy is highly variant dependent. In Vitro studies suggest a lack of efficacy for omicron [Liu, Sheward, VanBlargan]. Monoclonal antibody use with variants can be associated with prolonged viral loads, clinical deterioration, and immune escape [Choudhary]. Bamlanivimab/etesevimab has been officially adopted for early treatment in 3 countries. Submit updates/corrections.
Oct 4
Covid Analysis (Preprint) (meta analysis) Bamlanivimab/etesevimab for COVID-19: real-time meta analysis of 14 studies
Statistically significant improvements are seen for mortality, ICU admission, hospitalization, recovery, and cases. 11 studies from 9 independent teams (all from the same country) show statistically significant improvements in isolation..
Aug 22
Chew et al., Nature Communications, doi:10.1038/s41467-022-32551-2 Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19
25% lower hospitalization [p=0.6], 14% slower recovery [p=0.97], 1% higher progression [p=1], and 26% improved viral clearance [p=0.002]. RCT 317 outpatients in the USA showing faster viral load and inflammatory biomarker decline, but no significant differences in clinical outcomes.
Mar 31
Wilden et al., Journal of the National Comprehensive Cancer Network, doi:10.6004/jnccn.2021.7309 Real World Outcomes of Cancer Patients With SARS-CoV-2 Infection Receiving Monoclonal Antibodies
51% lower hospitalization [p=0.06]. Retrospective 395 patients in the USA receiving casirivimab/imdevimab or bamlanivimab, showing lower risk of hospitalization with treatment, statistically significant for casirivimab/imdevimab.
Feb 16
Zhou et al., bioRxiv, doi:10.1101/2022.02.15.480166 (Preprint) (In Vitro) SARS-CoV-2 Omicron BA.2 Variant Evades Neutralization by Therapeutic Monoclonal Antibodies
In Vitro study showing that omicron BA.2 evades all monoclonal antibodies tested, including sotrovimab and tixagevimab/cilgavimab which retained activity for omicron BA.1.
Feb 9
Dale et al., Journal of the American Geriatrics Society, doi:10.1111/jgs.17705 Clinical Outcomes of Monoclonal Antibody Therapy During a COVID ‐19 Outbreak in a Skilled Nursing Facility‐Arizona, 2021
89% lower mortality [p=0.01] and 86% lower progression [p=0.002]. Retrospective 75 COVID+ patients in a skilled nursing facility in the USA, 56 treated within a median of 2 days from symptom onset with bamlanivimab, showing significantly lower mortality with treatment.
Jan 27
Delasobera et al., Infectious Diseases in Clinical Practice, doi:10.1097/IPC.0000000000001109 Impact of Rapidly Deployed COVID-19 Monoclonal Antibody Infusion Clinics on Rate of Hospitalization
52% lower hospitalization [p=0.01] and 20% lower progression [p=0.52]. Retrospective 438 patients in the USA, 253 treated with bamlanivimab, showing significantly lower hospitalization with treatment.
Jan 27
Priest et al., Infectious Diseases in Clinical Practice, doi:10.1097/IPC.0000000000001130 Bamlanivimab for the Prevention of Hospitalizations and Emergency Department Visits in SARS-CoV-2–Positive Patients in a Regional Health Care System
no change in mortality [p=1], 4% higher hospitalization [p=0.86], and 5% more combined hospitalization/ER visits [p=0.86]. Retrospective 379 bamlanivimab patients and 379 matched controls in the USA, showing no significant differences with treatment.
Dec 20
Sheward et al., bioRxiv, doi:10.1101/2021.12.19.473354 (Preprint) (In Vitro) Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron)
In Vitro study showing that omicron is substantially resistant to neutralization by monoclonal antibodies REGN10933, REGN10987, Ly-CoV016 and Ly-CoV555. S309 (the parent of Sotrovimab) had only 2-fold loss in potency.
Dec 17
VanBlargan et al., bioRxiv, doi:10.1101/2021.12.15.472828 (Preprint) (In Vitro) An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by several therapeutic monoclonal antibodies
In vitro study (Vero-TMPRSS2 and Vero-hACE2-TMPRSS2) showing complete loss of inhibitory activity for B.1.1.529 omicron with LY-CoV555, LY-CoV016, REGN10933, REGN10987, and CT-P59, ~12-fold decrease for COV2-2196/COV2-2130, and minimal ch..
Dec 15
Liu et al., bioRxiv, doi:10.1101/2021.12.14.472719 (Preprint) (In Vitro) Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2
In vitro study (Vero-E6-TMPRSS2) showing 18 of 19 monoclonal antibodies were no longer effective or significantly impaired with B.1.1.529 omicron.
Nov 3
Rubin et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab546 Bamlanivimab efficacy in older and high BMI outpatients with Covid-19 selected for treatment in a lottery-based allocation process
65% lower hospitalization [p=0.04]. Retrospective database analysis of 1257 PCR+ outpatients with age ≥65, BMI≥35, 191 receiving bamlanivimab via lottery. Authors note that the alpha variant was most common during the study period, and that efficacy against other variants c..
Nov 2
Kaleta et al., Research Square, doi:10.21203/ (Preprint) Antibody escape and global spread of SARS-CoV-2 lineage A.27
Anaysis of antibody escape showing variant A.27 completely escaped neutralization with LY-COV555 and partially with REGN10987. B.1.617.2 escaped these antibodies in a similar manner, suggesting that L452R facilitates the escape. Authors n..
Oct 29
Schiaroli et al., Mediterranean Journal of Hematology and Infectious Diseases, doi:10.4084/MJHID.2021.061 Early Treatment with BamlanivimabAlone does not Prevent COVID-19 Hospitalization and Its Post-Acute Sequelae. A Real Experience in Umbria, Italy
Retrospective 39 patients treated with bamlanivimab in Italy, showing results far below expectations based on the BLAZE1 trial. Authors note that most patients had the alpha variant which does not have the E484K and L452R mutations known ..
Oct 8
Cooper et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab512 Real-world Assessment of 2,879 COVID-19 Patients Treated with Monoclonal Antibody Therapy: A Propensity Score-Matched Cohort Study
58% lower ICU admission [p=0.33] and 5% lower hospitalization [p=0.86]. Retrospective 2,879 patients and matched controls in the USA, showing significantly lower mortality and hospitalization with bamlanivimab, bamlanivimab/etesevimab, and casirivimab/imdevimab. There was significantly lower hospitalization w..
Oct 7
Dougan et al., New England Journal of Medicine, doi:10.1056/NEJMoa2102685 Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19
95% lower mortality [p=0.002], 70% lower combined mortality/hospitalization [p=0.0002], 11% faster recovery [p=0.007], and 67% improved viral clearance [p<0.0001]. Results from the BLAZE-1 RCT of combined bamlanivimab/etesevimab, showing significantly lower mortality and combined mortality/hospitalization with treatment. NCT04427501.
Oct 1
Ganesh et al., Journal of Clinical Investigation, doi:10.1172/JCI151697 Intravenous bamlanivimab use associates with reduced hospitalization in high-risk patients with mild to moderate COVID-19
74% lower mortality [p=0.11], 49% lower ICU admission [p=0.1], and 37% lower hospitalization [p=0.01]. Retrospective 2,335 bamlanivimab patients and 2,335 PSM controls in the USA, showing significantly lower hospitalization with treatment.
Sep 15
Choudhary et al., medRxiv, doi:10.1101/2021.09.03.21263105 (Preprint) Emergence of SARS-CoV-2 Resistance with Monoclonal Antibody Therapy
Analysis of ACTIV-2/A5401, showing the potential for rapid emergence of resistance during monoclonal antibody treatment, resulting in prolonged high level viral loads and clinical worsening. Treatment-emergent resistance mutations were mo..
Jun 23
Webb et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab331 Real-World Effectiveness and Tolerability of Monoclonal Antibody Therapy for Ambulatory Patients with Early COVID-19
80% lower mortality [p=0.09], 53% lower hospitalization [p<0.0001], and 27% fewer combined hospitalization/ER visits [p<0.0001]. Retrospective 479 patients treated with bamlanivimab showing lower mortality, hospital admission, and emergency department visits with treatment. Authors incorrectly state that "no other COVID-19 therapies for ambulatory patients hav..
May 18
Focosi et al., Research Square, doi:10.21203/ (Preprint) Emergence of SARS-CoV-2 Spike Escape Mutation Q493r After Bamlanivimab/Etesevimab Treatment for COVID-19
Case study showing that a mutation resistant to both bamlanivimab and etesevimab can arise in vivo. Authors note that accelerated evolution can occur under selective pressure from therapeutic interventions with neutralizing antibodies, an..
Mar 30
Bariola et al., medRxiv, doi:10.1101/2021.03.25.21254322 (Preprint) Impact of monoclonal antibody treatment on hospitalization and mortality among non-hospitalized adults with SARS-CoV-2 infection
67% lower mortality [p=0.05], 64% lower combined mortality/hospitalization [p=0.0003], and 61% lower hospitalization [p=0.001]. Retrospective 234 patients receiving bamlanivimab and 234 matched controls, showing lower hospitalization and mortality with treatment. Greater benefit was seen with administration within 4 days of their positive COVID-19 test.
Jan 21
Lilly, Press Release (Preprint) Lilly's neutralizing antibody bamlanivimab (LY-CoV555) prevented COVID-19 at nursing homes in the BLAZE-2 trial, reducing risk by up to 80 percent for residents
57% fewer symptomatic cases [p=0.0002]. Press release on the BLAZE-2 trial at nursing homes showing significantly lower symptomatic COVID-19 with treatment.
Jan 21
Gottlieb et al., JAMA, doi:10.1001/jama.2021.0202 Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19
71% fewer combined hospitalization/ER visits [p=0.05]. RCT for LY-CoV555 monotherapy and LY-CoV555/LY-CoV016 combination therapy with 592 patients showing lower hospitalization/ER visits with treatment. For viral load at day 11, a statistically significant reduction was found with combination..
Dec 22
ACTIV-3/TICO LY-CoV555 study group, NEJM, doi:0.1056/NEJMoa2033130 A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19
100% higher mortality [p=0.22]. Late stage RCT of LY-CoV555 added to remdesivir, showing non-statistically significant higher mortality with the addition of LY-CoV555.
Oct 28
Chen et al., NEJM, doi:10.1056/NEJMoa2029849 SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19
74% lower hospitalization [p=0.02]. Interim analysis of the BLAZE-1 phase 2 trial of outpatients showing lower hospitalization or ER visits (1.6% versus 6.3%), and improvements in symptoms and viral load compared to placebo. NCT04427501.
Oct 26
Lilly, Press Release (News) Lilly Statement Regarding NIH’s ACTIV-3 Clinical Trial
ACTIV-3 intermin analysis shows LY-CoV555 is unlikely to help hospitalized patients. ACTIV-2, BLAZE-1 and BLAZE-2 trials remain ongoing.
Oct 7
Lilly, Press Release (Preprint) SARS-CoV-2 neutralizing antibody program update
84% lower hospitalization [p=0.05]. Interim results from the BLAZE-1 outpatient RCT showing improvements in viral load, symptoms and hospitalization. Combination therapy significantly reduced viral load at day 11 (p=0.011). A greater effect is seen at day 7 (p<0.001). The p..
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