New data from phase 3 trials of monoclonal antibodies for patients with recent COVID-19 diagnoses, or at high risk for SARS-CoV-2 infection, could move the needle on clinician acceptance of the treatments, experts say.
Two monoclonal antibody formulations, Eli Lilly’s bamlanivimab and Regeneron’s cocktail of two antibodies, casirivimab and imdevimab, received emergency use authorizations from the US Food and Drug Administration in November to treat mild to moderate COVID-19 in outpatients. But current recommendations from the Infectious Diseases Society of America’s COVID-19 treatment and guideline panel, based on data from a phase 2 trial of bamlanivimab, suggest against the routine use of the drug.
Data from phase 3 trials, for which the companies announced topline results in press releases last week, could result in a revision of the IDSA guidelines when published more formally and the committee convenes on the issue again, said Jason C. Gallagher, PharmD, a clinical professor at Temple University’s School of Pharmacy and a member of the IDSA panel. It already appears to be encouraging clinician acceptance throughout the country, physicians said.
The new data from Regeneron indicate that people who were recently exposed to SARS-CoV-2 and received its monoclonal antibodies had fewer confirmed infections than people in the trial who received placebo. In Lilly’s trial, high-risk patients newly diagnosed with COVID-19 who received a combination of its monoclonal antibodies bamlanivimab and etesevimab had fewer COVID-related hospitalizations and deaths than those who got a placebo.
“It’s validating what already looked to be going that way,” said Gallagher. “It makes sense that if you give someone passive immunity, it’s going to keep them from being admitted.” However, he did not want to speak for the IDSA committee before they meet, and noted it would need more information than was provided in the press releases.
Physicians critiqued the results of phase 2 trials of monoclonal antibodies for the quality of the analysis and limited scope of the research. Those early findings were “inherently fragile,” Gallagher said, but the results of the phase 3 trials, once published, will provide the most reliable information on the drugs to date.
Regeneron’s results came from an exploratory analysis of 409 randomized participants from an ongoing phase 3 trial testing its monoclonal antibodies for the prevention of COVID-19 in people who live with a COVID-19 patient. The company reported a 50% reduction of overall infections in the treatment group compared with placebo. No participants who received the antibody cocktail had symptomatic infections, while eight in the placebo group did.
Read the full article here: https://www.medscape.com/viewarticle/945136
