GSK presents data from AReSVi-006 trial

GSK announced new data from the AReSVi-006 phase III trial evaluating the efficacy and safety of a single dose of Arexvy against lower respiratory tract disease, or LRTD, caused by respiratory syncytial virus, or RSV, in adults aged 60 years and older, including those at increased risk, over three full RSV seasons. These data will be presented at the CHEST 2024 Annual Meeting, organized by the American College of Chest Physicians. Arexvy is the world’s first RSV vaccine and was approved based on efficacy in adults aged 60 and older including those who are at increased risk due to certain underlying medical conditions. These results indicate that after a single dose of GSK‘s RSV vaccine, cumulative efficacy over three full RSV seasons was clinically meaningful at 62.9% against RSV-LRTD and 67.4% against severe RSV-LRTD compared to placebo. In the third season, the vaccine’s efficacy was 48.0% against RSV-LRTD. Safety and reactogenicity data were consistent with previous results from the phase III program. In season one, the vaccine was generally well tolerated. The most frequently observed adverse events were pain at the injection site, fatigue, myalgia, headache, and arthralgia within four days of vaccination. These results include efficacy against different RSV subtypes, in adults with advancing age and those with certain underlying medical conditions. Since RSV can exacerbate medical conditions and potentially lead to hospitalizations, cumulative efficacy over three RSV seasons has the potential for significant health impact. It has the potential to offer health care professionals flexibility to administer the vaccine year-round. Over time, revaccination is expected to be required to maintain an optimal level of protection. GSK will continue to share efficacy and immune response data, including on revaccination, with recommending bodies to inform decisions on immunization schedules and future revaccination. In addition to the presentation at CHEST, the data will be submitted for scientific peer-reviewed publication and to regulators for review.