Intramuscular sotrovimab noninferior to IV administration for COVID-19
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A 500 mg intramuscular injection of sotrovimab was noninferior to an IV infusion of the investigational monoclonal antibody for the treatment of mild to moderate COVID-19 in a phase 3 trial, investigators reported.
The FDA issued an emergency use authorization for IV sotrovimab last May for the treatment of mild to moderate COVID-19 in patients at risk for progressing to severe disease. GlaxoSmithKline and Vir Biotechnology, who developed sotrovimab together, submitted an EUA request last month to also get the therapy authorized as an intramuscular injection based on the results of a trial published previously on a preprint server and presented this week at the Conference on Retroviruses and Opportunistic Infections.
Anita Kohli, MD, MS, the clinical research director at Arizona Liver Health, reported data from COMET-TAIL, a phase 3, randomized, multicenter, open-label, noninferiority study of sotrovimab for the treatment of mild to moderate COVID-19 in participants aged 12 years or older at high risk for disease progression.
The study enrolled participants from June through August, which coincided with the delta variant surge in the United States. Approximately 85% of patients were Hispanic, and about 25% were aged 65 years or older.
The study’s primary objective was to evaluate the efficacy of sotrovimab given as a 500 mg intramuscular injection vs. a 500 mg IV infusion in preventing hospitalizations for more than 24 hours “for acute management of illness due to any cause or death.”
Of the 376 participants who received 500 mg of sotrovimab intramuscularly, 2.7% met the primary endpoint compared with 1.3% of the 378 participants who received an IV infusion — an adjusted risk difference of 1.07% (95% CI, –1.25% to 3.39%), which met the noninferiority margin of 3.5%.
“Sotrovimab targets a highly conserved epitope in the SARS-CoV-2 spike protein, which may allow sotrovimab to retain activity against highly emerging variants which may be resistant to other monoclonal antibodies,” Kohli said.
“The ability to administer sotrovimab via intramuscular administration is anticipated to allow increased access for patients in need of urgent treatment,” she said.
References:
GSK and Vir submit emergency use authorization application to FDA for intramuscular administration of sotrovimab for the early treatment of COVID-19. https://investors.vir.bio/news-releases/news-release-details/gsk-and-vir-submit-emergency-use-authorization-application-fda. Published Jan. 13, 2022. Accessed Feb. 17, 2022.
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Kohli A, et al. LB 102. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 12-16, 2022 (virtual meeting).
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