Publication date: May 24, 2025

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

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