October 12, 2022
(press release)
–
Reinforcing the strength of GSK's portfolio of vaccines, data from an extension study exploring the efficacy and safety of Shingrix over ten years will also be shared for the first time, providing further evidence on the duration of protection for adults aged 50 years and over. This long-term follow-up study from two previous phase III clinical trials (ZOE-50 and ZOE-70), which initially demonstrated up to 97% efficacy[1], [2], [3]in adults aged 50 years and older, will be presented on
Submissions also include presentations from
GSK ID Week data summary In addition to the pivotal phase III efficacy data, GSK will share three additional abstracts for its RSV OA vaccine candidate. One from a trial exploring co-administration of the RSV OA vaccine candidate with flu vaccination, and two from a phase III immunogenicity and safety trial. A further 17 abstracts by
Four abstracts have been accepted as poster presentations on Xevudy (sotrovimab), including data from the Fair Health study, a retrospective claims database analysis of high-risk patients with COVID-19. Another six abstracts have been accepted as poster presentations for gepotidacin, a potential first-in-class antibiotic.
Abstract Title First author Presentation A Respiratory Syncytial Virus (RSV) Prefusion F Protein Candidate Vaccine (RSVPreF3 OA) is Efficacious in Adults ≥ 60 Years of Age (YOA)
Oral A Candidate Respiratory Syncytial Virus (RSV) Prefustion F Protein Investigational Vaccine (RSVPreF3 OA) Is Immunogenic when Administered in Adults ≥ 60 Years of Age: Results at 6 Months after Vaccination
Poster Safety and Reactogenicity of an Investigational Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine for Adults ≥ 60 Years of Age (RSVPreF3 OA): an Interim Analysis at 6 Months after Vaccination
Poster Immunogenicity, reactogenicity and safety of a Respiratory Syncytial Virus prefusion F (RSVPreF3) candidate vaccine co-administered with the seasonal quadrivalent influenza vaccine in older adults
Poster Long-term Protection Against Herpes Zoster (HZ) by the Adjuvanted Recombinant Zoster Vaccine (RZV): Interim Efficacy,
Anne Strezova Poster Real-World Effectiveness of Sotrovimab for the Early Treatment of COVID-19 in the US
Poster Safety, Tolerability, and Viral Pharmacodynamics of the IgG Monoclonal Antibody Sotrovimab Administered via Intramuscular Injection for the Treatment of Early Mild-to-Moderated COVID-19
Poster Viral Resistance Analysis in the COMET-PEAK Study: Sotrovimab Treatment in Participants With Mild-to-Moderate COVID-19
Poster Resistance Analysis in the COMET-TAIL Study: Participants With Mild-to-Moderate COVID-19 Treated with Intramuscular or Intravenous Sotrovimab
Poster Analysis of Co-Resistance Among Escherichia coli Urine Isolates from Female Outpatients in
Poster Analysis of Co-Resistance Among Klebsiella pneumoniae Urine Isolates from Female Outpatients in
Poster Prevalence, Regional Distribution, and Trends of Antimicrobial Resistance Among Female Outpatients with Urine Klebsiella pneumoniae Isolates: A Multicenter Evaluation
Poster Patient Perceptions of Treatment Success in Uncomplicated Urinary Tract Infection
Poster Activity of Gepotidacin Tested Against Molecularly Characterized Escherichia coli Isolates Resistant to Commonly Used Oral Therapies for UTI in the US (2019-2020)
Poster Activity of Gepotidacin Against Escherichia coli Isolates from Community-acquired Urinary Tract Infections Collected Between 2019-2021 in
Poster Systematic Literature Review of Real-world Experience with the 2-Drug Regimen Dolutegravir and Lamivudine in People with HIV
Poster Efficacy and Safety of Switching to DTG/3TC in Virologically Suppressed PLWH by Age, Including Those Aged ≥65 Years: Pooled Results from the TANGO and SALSA Studies
Poster Suppressed Switch to DTG/3TC 2-Drug Regimen vs BIC- or DTG-Based 3-Drug Regimens
Hot Zone Poster* Effectiveness and Durability of Dolutegravir (DTG) Based Regimens in Older People Living with HIV (PLWH) from the Veterans Aging Cohort Study (VACS)
Poster Real World Treatment Experience of Treatment-Naive People with HIV
Poster Real World Treatment Experience of Single Tablet Dolutegravir/Lamivudine in Those Naive to Treatment with Baseline Viral Loads ≥100,000 Copies/mL in the US
Poster A Real-world Observational Study on HIV-Infected Patients
Poster CARISEL: A Hybrid III Implementation Effectiveness Study of Implementation of Cabotegravir Plus Rilpivirine Long Acting (CAB+RPV LA) in EU Health Care Settings; Key Clinical and Implementation Outcomes by Implementation Arm
Oral Phase 3/3b Experience with Long-Acting Cabotegravir and Rilpivirine: Efficacy and Safety Outcomes Through Week 96 by Race
Oral Real-world Use of Long-Acting Cabotegravir + Rilpivirine in the US: Effectiveness in the First Year
Oral US Healthcare Provider Perspectives on the Initiation of Cabotegravir and Rilpivirine Long-Acting (CAB+RPV LA) in an Observational Real-world Study (BEYOND)
Poster Awareness and Interest in PrEP Options Among US Cisgender Women - A
Oral PrEP Interest and Preferences Among US Black and Hispanic Men - A
Poster Relative Patient Preferences for
Hot Zone Poster Durability and Effectiveness of Fostemsavir in Heavily Treatment-Experienced People with HIV
Hot Zone Poster An Increase in Single-Tablet Regimen (STR) Utilisation for People Living with HIV (PLWH) Enrolled in Medicaid Had Minimal Impact on Pharmacy Costs
Poster Clinical and Sociodemographic Characteristics Associated with
Poster Single-Tablet Regimens (STR) Offer Better Persistence and Adherence, with Lower Costs by Adherence Status, Than Multiple-Tablet Regimens (MTR) for People Living with HIV (PLWH) Enrolled in Medicaid
Poster About infectious diseases Infectious diseases are a significant global health and economic burden and are responsible for more than one in six deaths, worldwide.[5]GSK's commitment to preventing and treating infectious diseases is reflected by the broad portfolio of marketed products. Our global specialist company,
About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com/company Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2021, GSK's Q2 Results for 2022 and any impacts of the COVID-19 pandemic. References [1]Lal H et al. Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults. N Engl J Med. 2015;372:2087-96. [2] Cunningham et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375:1019-32. [3]ZOE-50 and ZOE-70 are placebo-controlled trials with two doses of recombinant zoster vaccine (RZV) two months apart. Vaccine efficacy (VE) was assessed in the modified Total Vaccinated Cohort (mTVC) of 7277 participants, i.e. excluding adults
[4]
[5] Global Health Estimates 2019: Global Health Estimates: Life expectancy and leading causes of death and disability.
Attachments Disclaimer
First presentation of RSV Older Adult vaccine candidate's pivotal phase III efficacy and safety data
New data showing Shingrix efficacy and safety over ten years
Results on implementation of long-acting HIV treatment, Vocabria/Rekambys, in clinical setting
Breadth of data presented demonstrates GSK's expertise and commitment to preventing and treating infectious diseases
* All content is copyrighted by Industry Intelligence, or the original respective author or source. You may not recirculate, redistrubte or publish the analysis and presentation included in the service without Industry Intelligence's prior written consent. Please review our terms of use.