Merck Reports Data From Planned Interim Analysis Of MK-1654-007 Trial; Interim Results Showed Clesrovimab Had Comparable Safety Profile To Palivizumab And No Drug-Related Serious Adverse Events Were Reported To Date

Merck also announced data from a planned interim analysis of the MK-1654-007 trial, a Phase 3 trial evaluating the safety and efficacy of clesrovimab versus palivizumab in infants and children at increased risk for severe RSV disease.

The primary endpoint of the study is the safety and tolerability of clesrovimab in infants entering their first RSV season. Interim results showed clesrovimab had a comparable safety profile to palivizumab, and no drug-related serious AEs were reported to date.

Incidence rates of RSV-associated MALRI requiring ≥ 1 indicator of LRI or severity and RSV-associated hospitalizations (secondary endpoints) were also comparable between clesrovimab (3.6% and 1.3%, respectively) and palivizumab (3.0% and 1.5%, respectively) through Day 150 (5 months).