New data for Arexvy, GSK’s RSV vaccine, show potential to help protect adults aged 50 to 59 at increased risk for RSV disease
· Preliminary results from phase III trial show primary endpoints met, with non-inferior immune responses observed in adults aged 50-59 compared to adults aged 60 and older
· Adults aged 50 and above with certain underlying medical conditions are at increased risk for RSV disease1
· GSK is on track to be the first company to submit data in this population to regulators, with decisions on potential label expansion expected in 2024
GSK plc (LSE/NYSE: GSK) today announced positive preliminary results from its phase III trial [https://clinicaltrials.gov/study/NCT05590403] evaluating the immune response and safety of Arexvy (respiratory syncytial virus vaccine, adjuvanted) in adults aged 50 to 59, including those at increased risk of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) due to certain underlying medical conditions. These results will be presented at the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) meeting on 25 October 2023. This vaccine is currently approved in the US for active immunisation for the prevention of RSV-LRTD in adults 60 years of age and older. It is also approved in Europe, Japan and several other countries.
The vaccine elicited an immune response in adults aged 50 to 59 at increased risk for RSV disease due to select underlying medical conditions that was non-inferior to that observed in adults aged 60 and above, meeting the trial’s primary co-endpoint. Vaccine efficacy has previously been demonstrated in adults aged 60 and above. The co-primary endpoint was also met for the broader group of adults aged 50 to 59 also enrolled in the trial. Safety and reactogenicity data were consistent with results from the initial phase III programme. The most common local adverse event was pain, and most common systematic adverse events were fatigue and headache, most of which were transient and mild in intensity.
Tony Wood, Chief Scientific Officer, GSK, said: “This trial reinforces our confidence in our RSV vaccine’s ability to help protect adults aged 50 to 59 at increased risk for RSV-LRTD. We will submit these data for regulatory review as quickly as possible with the goal of offering adults in this age group the option of a vaccine for the first time.”
RSV is a common, contagious virus that can cause severe respiratory illness.2 Estimated rates of infection and hospitalisation may be higher than reported in many high income countries, including the US.3 There is a substantial burden of RSV-associated illness for adults at increased risk for RSV disease due to advanced age, immunocompromised status, or underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure. RSV can exacerbate these conditions and lead to pneumonia, hospitalisation, or death.4
Final results from this trial will be presented at an upcoming medical conference and submitted for peer-reviewed publication. The data will also be submitted to the US Food and Drug Administration (FDA) and other regulators to support potential label expansions.