2023 Guidance and Q3 Earnings
Delivering important new data to prevent infectious disease
Arexvy: phase III trial demonstrated non-inferiority in
adults 50-59 compared to adults ≥60 years of age
Co-primary end points met. Humoral response non-inferior in populations
with or without comorbidities
Day 31 per protocol set for humoral
RSV-A
Cohort 2 (≥60) divided by
Cohort 1a (50-59)
Cohort 2 (≥ 60) divided by
RSV-B
Cohort 1a (50-59)
0.5
GMT Ratio
(with comorbidities associated with RSV-LRTD)
1.0
1.5
GMT Ratio
RSV-A
Cohort 2 (≥ 60) divided by
Cohort 1b (50-59)
RSV-B
Cohort 2 (≥ 60) divided by
Cohort 1b (50-59)
(without comorbidities associated with RSV-LRTD)
0.5
1.0
1.5
GMT Ratio
(95% CI)
0.84
(0.73, 0.96)
0.82
(0.72, 0.93)
2.0
GMT Ratio
(95% CI)
2.0
0.95
(0.83, 1.09)
0.90
(0.79, 1.03)
Success Criteria: Upper limit of 2-sided CI for GMT ratio is ≤1.5
Cohort 1a: Adults 50-59 with comorbidities associated with RSV-LRTD; Cohort 1b: Adults 50-59 without comorbidities associated with RSV-LRTD; Cohort 2: Adults
≥ 60 YOAGMT, geometric mean titer; CI, confidence interval; LRTD, lower respiratory tract disease; Preliminary data; RSV response evaluated using NAb (ED60);
ED60, serum estimated dilution inducing 60% inhibition in plaque-forming units; Nab, neutralizing antibody
Shingrix. new data demonstrate 100% vaccine
efficacy in the prevention of shingles in adults
aged 50 and over in China
•
Herpes zoster virus (shingles)
6 million
cases in China each year²
ZOSTER-076 phase IV trial³ evaluated the prophylactic efficacy and
safety of Shingrix in preventing shingles in adults aged 50 and over in
China
No cases of shingles were reported among the participants who received
Shingrix; vaccine efficacy was 100% (95% CI: 89.82%-100%)
The safety profile observed in this trial was consistent with the established
safety profile of the vaccine
Q4 2023: peer-reviewed scientific publication
Q4 2023: regulatory submission of sBLA
GSK
1. Supplementary Biologics Application 2. Zhang Z et al. The incidence of herpes zoster in China: A meta-analysis and evidence quality assessment. Hum Vaccin Immunother. 2023;19(2):2228169 3. The trial included almost
6,000 participants randomised 1:1 to the RZV or placebo group and followed in an observer-blind design. No cases of shingles were reported among the participants who received RZV, compared to 31 cases in the placebo arm. 10View entire presentation