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Safety and Efficacy of Pemivibart, a Long-Acting Monoclonal Antibody, for Prevention of Symptomatic COVID-19: Interim Results From a Phase 3 Randomized Clinical Trial (CANOPY)

Wolfe et al., Clinical Infectious Diseases, doi:10.1093/cid/ciaf265, CANOPY, NCT06039449, Nov 2024 (preprint)
https://c19early.org/wolfe.html
Mortality -150% Improvement Relative Risk Hospitalization 75% Case, hospitalization.. 74% Symp. case 76% Pemivibart  CANOPY  Prophylaxis  RCT Is prophylaxis with pemivibart beneficial for COVID-19? RCT 477 patients in the USA (November - December 2023) Lower progression (p<0.0001) and fewer symptomatic cases (p<0.0001) c19early.org Wolfe et al., Clinical Infectious Dise.., Nov 2024 Favorspemivibart Favorscontrol 0 0.5 1 1.5 2+
Phase 3 trial of 306 immunocompromised adults and 484 non-immunocompromised adults showing pre-exposure prophylaxis with pemivibart was generally well-tolerated and provided protection against symptomatic COVID-19 through 6 months in immunocompromised individuals and 12 months in non-immunocompromised individuals.
Efficacy is variant dependent. In Vitro research shows reduced efficacy against KP.3.1.1, KP.1.1, LB.1, KP.3.3, and XEC variants1-4.
Standard of Care (SOC) for COVID-19 in the study country, the USA, is very poor with very low average efficacy for approved treatments5. Only expensive, high-profit treatments were approved for early treatment. Low-cost treatments were excluded, reducing the probability of early treatment due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.
risk of death, 150.5% higher, RR 2.50, p = 1.00, treatment 1 of 317 (0.3%), control 0 of 160 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), day 365.
risk of hospitalization, 74.9% lower, RR 0.25, p = 0.34, treatment 0 of 317 (0.0%), control 1 of 160 (0.6%), NNT 160, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 365.
case, hospitalization, death, 73.9% lower, RR 0.26, p < 0.001, treatment 15 of 317 (4.7%), control 29 of 160 (18.1%), NNT 7.5, day 365.
risk of symptomatic case, 75.6% lower, RR 0.24, p < 0.001, treatment 14 of 317 (4.4%), control 29 of 160 (18.1%), NNT 7.3.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Wolfe et al., 13 Nov 2024, Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, median age 59.0, 17 authors, study period November 2023 - December 2023, trial NCT06039449 (history) (CANOPY). Contact: aholmes@invivyd.com, phawn@invivyd.com.
Safety and Efficacy of Pemivibart, a Long-Acting Monoclonal Antibody, for Prevention of Symptomatic COVID-19: Interim Results From the CANOPY Clinical Trial
Cameron R Wolfe, Jonathan Cohen, Kathryn Mahoney, Anna Holmes, Natalia Betancourt, Deepali Gupta, Kazima Tosh, Kristin Narayan, Ed Campanaro, Chloe Katz, Anne-Marie Phelan, Ilker Yalcin, Mark Wingertzahn, Pamela Hawn, Pete Schmidt, Yong Li, Myra Popejoy
doi:10.1101/2024.11.11.24317127
Key points: Pre-exposure prophylactic administration of 2 doses of pemivibart approximately 90 days apart was generally well-tolerated and provided protection against symptomatic COVID-19 through 6 months in individuals with immunocompromise and 12 months in individuals without immunocompromise, respectively.
Author contributions M.P., A.H., Y.L., I.Y., E.C., and K.N. contributed to study design. M.P., A.H., Y.L., I.Y., D.G., K.N., E.C., and A.P. were involved in protocol development. J.C. was a principal investigator. M.P., A.H., K.M., and N.B. were responsible for medical monitoring. All authors contributed to data interpretation and were involved in drafting and critically revising the manuscript, and all authors approved the final version and are accountable for the accuracy and integrity of the manuscript. All authors had full access to the data in the study and had final responsibility for the decision to submit for publication. Y. L., D.G., and K.N. verified the data. Potential conflicts of interest. Investigative sites and institutions were compensated by Invivyd, Inc. for all participant visits, including enrollment/baseline and follow-up. K.M., A.H., N.B., D.G., K.T., K.N., E.C., C.K., A.P., I.Y., M.W., P.H., P.S., Y.L., and M.P. were employees of Invivyd, Inc., at the time the study was conducted and may hold stock or shares in Invivyd, Inc. Data availability As this trial is ongoing, data are not publicly available. Participants may have >1 immunocompromising condition or medication or risk factor for COVID-19 progression. c Taking high-dose corticosteroids (≥20 mg of prednisone or equivalent per day for at least 2 weeks), B-cell-depleting agents (within the past year), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, TNF blockers,..
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DOI record: { "DOI": "10.1093/cid/ciaf265", "ISSN": [ "1058-4838", "1537-6591" ], "URL": "http://dx.doi.org/10.1093/cid/ciaf265", "abstract": "<jats:title>Abstract</jats:title>\n <jats:sec>\n <jats:title>Background</jats:title>\n <jats:p>We report an interim analysis of safety and efficacy of pemivibart in individuals with (cohort A) or without (cohort B) significant immunocompromise in the phase 3 CANOPY trial.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Methods</jats:title>\n <jats:p>Eligible participants (≥18 years; negative for current SARS-CoV-2 infection) received 2 intravenous 4500-mg pemivibart infusions (cohort A) or were randomized 2:1 to receive blinded pemivibart or placebo (cohort B) 90 days apart. Safety was a primary endpoint for both cohorts. The primary immunobridging endpoint for cohort A has previously been reported. Composite incidence of reverse transcription-polymerase chain reaction-confirmed symptomatic COVID-19, COVID-19 hospitalization, and all-cause mortality was an exploratory endpoint.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Results</jats:title>\n <jats:p>In September-November 2023, 306 participants received pemivibart (cohort A); 317 received pemivibart and 162 placebo (cohort B). The most common study drug-related adverse events were infusion-related reactions (cohort A: 11/306 [3.6%]; cohort B: 7/317 [2.2%, pemivibart] and 0/162 [placebo]). Four of 623 (0.6%) participants who received pemivibart experienced anaphylactic reactions (2 serious). In cohort A, the composite COVID-19 incidence through month 6 was 11/298 (3.7%; 2 deaths). In cohort B, 6/317 (1.9%; no deaths) and 19/160 (11.9%; no deaths) pemivibart and placebo participants, respectively, met the endpoint through month 6 (84.1% standardized relative risk reduction [RRR; 95% CI, 60.9-93.5; nominal P&amp;lt;.0001]), and 15/317 (4.7%; 1 death) and 29/160 (18.1%; no deaths) pemivibart and placebo participants, respectively, met the endpoint through month 12 (73.9% standardized RRR [95% CI, 52.8-85.6; nominal P&amp;lt;.0001]). Twelve month protection was conferred with no additional dosing.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Conclusions</jats:title>\n <jats:p>Pemivibart provided prophylactic efficacy against COVID-19 and was well-tolerated by most participants. Anaphylaxis was an important safety risk.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Clinical Trials Registration</jats:title>\n <jats:p>NCT06039449</jats:p>\n </jats:sec>", "author": [ { "ORCID": "https://orcid.org/0000-0002-5365-5030", "affiliation": [ { "name": "Duke University , Durham, North Carolina ,", "place": [ "USA" ] } ], "authenticated-orcid": false, "family": "Wolfe", "given": "Cameron R", "sequence": "first" }, { "affiliation": [ { "name": "Jadestone Clinical Research , Silver Spring, Maryland ,", "place": [ "USA" ] } ], "family": "Cohen", "given": "Jonathan", "sequence": "additional" }, { "affiliation": [ { "name": "Invivyd, Inc. , Waltham, Massachusetts ,", "place": [ "USA" ] } ], "family": "Mahoney", "given": "Kathryn", "sequence": "additional" }, { "affiliation": [ { "name": "Invivyd, Inc. , Waltham, Massachusetts ,", "place": [ "USA" ] } ], "family": "Holmes", "given": "Anna", "sequence": "additional" }, { "affiliation": [ { "name": "Invivyd, Inc. , Waltham, Massachusetts ,", "place": [ "USA" ] } ], "family": "Betancourt", "given": "Natalia", "sequence": "additional" }, { "affiliation": [ { "name": "Invivyd, Inc. , Waltham, Massachusetts ,", "place": [ "USA" ] } ], "family": "Gupta", "given": "Deepali", "sequence": "additional" }, { "affiliation": [ { "name": "Invivyd, Inc. , Waltham, Massachusetts ,", "place": [ "USA" ] } ], "family": "Tosh", "given": "Kazima", "sequence": "additional" }, { "affiliation": [ { "name": "Invivyd, Inc. , Waltham, Massachusetts ,", "place": [ "USA" ] } ], "family": "Narayan", "given": "Kristin", "sequence": "additional" }, { "affiliation": [ { "name": "Invivyd, Inc. , Waltham, Massachusetts ,", "place": [ "USA" ] } ], "family": "Campanaro", "given": "Ed", "sequence": "additional" }, { "affiliation": [ { "name": "Invivyd, Inc. , Waltham, Massachusetts ,", "place": [ "USA" ] } ], "family": "Katz", "given": "Chloe", "sequence": "additional" }, { "affiliation": [ { "name": "Invivyd, Inc. , Waltham, Massachusetts ,", "place": [ "USA" ] } ], "family": "Phelan", "given": "Anne-Marie", "sequence": "additional" }, { "affiliation": [ { "name": "Invivyd, Inc. , Waltham, Massachusetts ,", "place": [ "USA" ] } ], "family": "Yalcin", "given": "Ilker", "sequence": "additional" }, { "affiliation": [ { "name": "Invivyd, Inc. , Waltham, Massachusetts ,", "place": [ "USA" ] } ], "family": "Wingertzahn", "given": "Mark", "sequence": "additional" }, { "affiliation": [ { "name": "Invivyd, Inc. , Waltham, Massachusetts ,", "place": [ "USA" ] } ], "family": "Hawn", "given": "Pamela", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0002-8664-3706", "affiliation": [ { "name": "Invivyd, Inc. , Waltham, Massachusetts ,", "place": [ "USA" ] } ], "authenticated-orcid": false, "family": "Schmidt", "given": "Pete", "sequence": "additional" }, { "affiliation": [ { "name": "Invivyd, Inc. , Waltham, Massachusetts ,", "place": [ "USA" ] } ], "family": "Li", "given": "Yong", "sequence": "additional" }, { 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