Clesrovimab: A potential new player to protect against RSV

In this Contemporary Pediatrics video interview, Octavio Ramilo, MD, chair, Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, highlighted key phase 2b/3 data for clesrovimab (Merck), an investigational monoclonal antibody designed to protect infants from RSV during their first season.

The potential preventative tool demonstrated positive phase 2b/3 study data (MK-1654-004; NCT04767373), which was presented at IDWeek 2024, in Los Angeles, California.

Clesrovimab met all prespecified endpoints in a placebo-controlled, phase 2b/3 pivotal trial evaluating a single dose in healthy preterm and full-term infants aged birth to 1 year. Results were consistent through both the 5-month and 6-month time points.

According to the announcement, reduction in incidence of RSV-associated medically attended lower respiratory infections (MALRI) that required 1 or more indicator of lower respiratory infection or severity compared to placebo through 5 months post-dose, was 60.4% (95% CI: 44.1, 71.9, [P <0.001]).

A key secondary endpoint was RSV-associated hospitalizations, for which clesrovimab reduced these hospitalizations by 84.2% (95% CI: 66.6, 92.6, [P <0.001]) through 5 months compared to placebo. A third endpoint was RSV-associated lower respiratory infection hospitalizations, which were reduced 90.9% with clesrovimab treatment compared to placebo through 5 months (95% CI: 76.2, 96.5). In addition, clesrovimab reduced the incidence of severe MALRI (tertiary endpoint) by 91.7% (95% CI: 62.9, 98.1), according to the Merck announcement.

Octavio Ramilo, MD discloses the following:

Board membership - RESVINET

Consultancies or paid advisory boards - Pfizer, Sanofi, Merck

Grants received/research funding - NIH, Gates Foundation, Janssen, Merck

Honoraria - Pfizer, Sanofi, Merck

Lecture fees for speaking at the invitation of a commercial sponsor - Pfizer, Sanofi, Merck

Reference:

Fitch, J. IDWeek: Clesrovimab reduces RSV disease, hospitalization in healthy infants. Contemporary Pediatrics. October 17, 2024. Accessed October 18, 2024. https://www.contemporarypediatrics.com/view/idweek-clesrovimab-reduces-rsv-disease-hospitalization-health-infants