Merck Announces Positive Data for V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults - Seite 2

In addition to the clinical data on V116, Merck also presented findings that suggest V116 may help to reduce the health and economic burden associated with invasive pneumococcal disease and non-bacteremic pneumococcal pneumonia among adults in France, Sweden, Spain, and the Netherlands.

V116 is currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The FDA granted V116 priority review with a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024. V116 is specifically designed to help protect adults from invasive pneumococcal disease; the serotypes in V116 account for approximately 83% of adult invasive pneumococcal disease in individuals 65 and older, according to U.S. Centers for Disease Control and Prevention data from 2018-2021. An overview of the V116 late-stage development program is available here.

Summary of Findings from Select Studies Presented at ESCMID

Data from STRIDE-10 (Abstract #353)

STRIDE-10 (NCT05569954) is a Phase 3, randomized, double-blind, active comparator-controlled study evaluating the immunogenicity, tolerability and safety of V116 compared to PPSV23 in adults 50 years of age and older who had not previously received pneumococcal vaccine (n=1,484). Participants were randomized to receive a single dose of either V116 or PPSV23.

The primary objectives included serotype-specific OPA GMTs 30 days post-vaccination and percentage of participants with greater than or equal to four-fold rise from baseline in serotype-specific OPAs. Serotype-specific OPA responses were measured at baseline and 30 days post-vaccination. Safety was evaluated as the proportion of participants with adverse events (AEs). Results demonstrated that:

• V116 elicited noninferior immune responses for the 12 serotypes (or strains) shared with PPSV23 (3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, 33F), as measured by serotype-specific OPA GMTs 30 days post-vaccination;
• V116 elicited superior immune responses for the nine serotypes only covered by V116 and not PPSV23 (6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, 35B), as assessed by serotype-specific OPA GMT ratios 30 days post-vaccination;
• The proportion of patients with ≥4-fold rise in OPA GMT ratios from Day 1 to Day 30 for serotype-specific OPA for V116 was superior to PPSV23 for eight out of nine serotypes unique to V116 compared to PPSV23;
• V116 had a comparable safety profile to PPSV23.

Data from Health and Economic Burden of Disease Studies (Abstract #7201, Abstract #2784, Abstract #2738, and Abstract #2843)