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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).

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). Clinical infectious diseases : an official publication of the Infectious Diseases Society of America Wolfe, C. R., Cohen, J., Mahoney, K., Holmes, A., Betancourt, N., Gupta, D., Tosh, K., Narayan, K., Campanaro, E., Katz, C., Phelan, A. M., Yalcin, I., Wingertzahn, M., Hawn, P., Schmidt, P., Li, Y., Popejoy, M. 2025

Abstract

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.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.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<.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<.0001]). Twelve month protection was conferred with no additional dosing.Pemivibart provided prophylactic efficacy against COVID-19 and was well-tolerated by most participants. Anaphylaxis was an important safety risk.NCT06039449.

View details for DOI 10.1093/cid/ciaf265

View details for PubMedID 40410927