Merck has announced positive data from the Phase III STRIDE-10 trial of its investigational pneumococcal conjugate vaccine, V116.
The 21-valent V116 vaccine is in Phase III development to prevent invasive pneumococcal disease and pneumococcal pneumonia in adults.
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The randomised, double-blind STRIDE-10 study assessed the vaccine’s immunogenicity, safety and tolerability against those of the 23-valent pneumococcal vaccine (PPSV23).
It enrolled adults aged 50 years and older who had not previously been vaccinated against pneumococcal disease. These subjects were given a single dose of either PPSV23 or V116.
The results demonstrated that V116 caused immune responses that were noninferior to PPSV23 for the 12 serotypes common to both vaccines.
V116 also showed superior immune responses for the nine serotypes unique to it, as well as a safety profile comparable to that of PPSV23.
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By GlobalDataMerck Scientific Advisory Committee member and Emory University medicine, epidemiology, global health and paediatrics emeritus professor Dr Walter Orenstein said: “Invasive pneumococcal disease and pneumococcal pneumonia represent significant public health challenges, particularly among older adult populations and those with risk conditions.
“These positive results show that V116 has the potential to help prevent invasive pneumococcal disease among adult populations.”
Merck’s research suggests that V116 could significantly reduce the health and economic impacts of invasive pneumococcal disease and non-bacteremic pneumococcal pneumonia in adults across several European countries.
V116 is currently under review by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
The FDA has granted the vaccine priority review, with a target action date set for 17 June this year.
Earlier this month, Merck began a Phase III clinical trial of its investigational oral selective Kirsten rat sarcoma glycine 12 to cysteine (KRAS G12C) inhibitor, MK-1084, alongside KEYTRUDA to treat metastatic non-small cell lung cancer.
