Pfizer releases results for severe RSV-associated LRTD treatment study
Natalia Elliot | August 13, 2024 | News story | Clinical Trial Services, Research and Development | Immunology, Pfizer, autoimmune, clinical trial, respiratory, vaccines
US-based Pfizer have announced results from its substudy B of the ongoing phase 3 clinical trial into the safety and immunogenicity of ABRYSVO in adult, immunocompromised patients at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD).
The MONeT study enrolled 203 adults, approximately half of which were aged 18-59, and the other half 60 years or older. Two doses of ABRYSVO were administered one month apart in four groups of patients: those with non-small cell lung cancer; those on haemodialysis due to end-stage renal disease; those with autoimmune inflammatory disorder receiving active immunomodulator therapy; and solid organ transplant recipients. ABRYSVO was found to be well-tolerated and showed a safety profile consistent with findings from other studies of the vaccine.
ABRYSVO has been approved by the US Food and Drug Administration (FDA) for the prevention of LRTD caused by RSV in multiple patient groups, and also recommended by the Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control (CDC). First, in May 2023, it was approved for patients aged 60 years or older, and the recommendation given for it to be used as a vaccine for all adults 75 years and older, or adults 60 years and older at increased risk of severe RSV disease. In August 2023, it was then approved for infants from birth to six months by active immunisation of pregnant individuals at 32-36 weeks gestational age, and in September 2023 the ACIP recommended maternal immunisation with ABRYSVO to protect newborns from seasonal RSV, meaning the vaccine should be administered from September to January.
“Immunocompromised adults, such as patients with cancer or autoimmune disorders, have a substantially increased risk of experiencing severe complications from RSV, yet there are currently no vaccines approved for those aged 18 to 59 in the US,” said Annaliesa Anderson PhD, senior vice president and chief scientific officer, Vaccine Research and Development, Pfizer. “We are encouraged by the positive top-line data from this study, which provide important evidence that ABRYSVO has the potential to address a significant unmet need in this vulnerable population.”
James Spargo
Related Content
UCB announces first-in-patient trial success for galvokimig in atopic dermatitis
UCB has reported positive early clinical trial results for galvokimig, an investigational therapy for adults …
FDA approves Wegovy for treatment of MASH in adults with liver fibrosis
The US Food and Drug Administration (FDA) has granted accelerated approval for Wegovy (semaglutide) as …
HUTCHMED completes enrolment in phase 3 trial for lung cancer
HUTCHMED has completed patient enrolment for the SANOVO phase 3 clinical trial, investigating the use …
