New phase III data shows investigational antibody cocktail casirivimab and imdevimab reduced hospitalisation or death by 70% in non-hospitalised patients with COVID-19

Regeneron, Press Release, Mar 2021

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https://c19early.org/regeneron3.html

Casirivimab/imdevimab

17th treatment shown to reduce risk in March 2021, now with p = 0.00018 from 33 studies, recognized in 52 countries. Efficacy is variant dependent.

Lower risk for hospitalization, progression, recovery, cases, and viral clearance.

No treatment is 100% effective. Protocols combine treatments.

5,600+ studies for 131 treatments. c19early.org

Press release for new phase III data showing lower hospitalization/mortality, and faster symptom resolution among the subset of patients with at least one risk factor.

Some variants may escape antibodies1.

Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for many omicron variants2-8.

Standard of Care (SOC) for COVID-19 in the study country, the USA, is very poor with very low average efficacy for approved treatments9. Only expensive, high-profit treatments were approved. Low-cost treatments were excluded, reducing the probability of treatment—especially early—due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.

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risk of death/hospitalization, 71.3% lower, RR 0.29, p < 0.001, treatment 18 of 1,355 (1.3%), control 62 of 1,341 (4.6%), NNT 30, 2,400mg IV, >=1 risk factor.

risk of death/hospitalization, 70.4% lower, RR 0.30, p = 0.003, treatment 7 of 736 (1.0%), control 24 of 748 (3.2%), NNT 44, 1,200mg IV, >=1 risk factor.

recovery time, 28.6% lower, relative time 0.71, p < 0.001, treatment 1,355, control 1,341, 2,400mg IV, >=1 risk factor.

recovery time, 28.6% lower, relative time 0.71, p < 0.001, treatment 736, control 748, 1,200mg IV, >=1 risk factor.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

1. cell.com, www.cell.com/cell/fulltext/S0092-8674(21)00367-6.www.cell.com/cell/fulltext/S0092-8674(21)00367-6.

2. Liu et al., Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2, bioRxiv, doi:10.1101/2021.12.14.472719.biorxiv.org, doi.org.

3. Sheward et al., Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron), bioRxiv, doi:10.1101/2021.12.19.473354.biorxiv.org, doi.org.

4. VanBlargan et al., An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by several therapeutic monoclonal antibodies, bioRxiv, doi:10.1101/2021.12.15.472828.biorxiv.org, doi.org.

5. Tatham et al., Lack of Ronapreve (REGN-CoV; casirivimab and imdevimab) virological efficacy against the SARS-CoV 2 Omicron variant (B.1.1.529) in K18-hACE2 mice, bioRxiv, doi:10.1101/2022.01.23.477397.biorxiv.org, doi.org.

6. Pochtovyi et al., In Vitro Efficacy of Antivirals and Monoclonal Antibodies against SARS-CoV-2 Omicron Lineages XBB.1.9.1, XBB.1.9.3, XBB.1.5, XBB.1.16, XBB.2.4, BQ.1.1.45, CH.1.1, and CL.1, Vaccines, doi:10.3390/vaccines11101533.mdpi.com, doi.org.

7. Haars et al., Prevalence of SARS-CoV-2 Omicron Sublineages and Spike Protein Mutations Conferring Resistance against Monoclonal Antibodies in a Swedish Cohort during 2022–2023, Microorganisms, doi:10.3390/microorganisms11102417.mdpi.com, doi.org.

8. Uraki et al., Antiviral efficacy against and replicative fitness of an XBB.1.9.1 clinical isolate, iScience, doi:10.1016/j.isci.2023.108147.sciencedirect.com, doi.org.

9. c19early.org, c19early.org/soc/usa.html.c19early.org/soc/usa.html.

Regeneron et al., 23 Mar 2021, Randomized Controlled Trial, USA, preprint, 1 author.

This Paper Casirivimab/i..All

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