Income Statement Presentation 2023
VABYSMO
Roche
Vabysmo: Chosen disease criteria impacts dosing interval
Vabysmo nAMD trials use vision or anatomical disease activity criteria, reflecting clinical practice¹
≥ 5 letters BCVA
loss vs avg. BCVA
over previous 2
scheduled visits,
due to nAMD*
Different ≥Q12W disease criteria as applied to TENAYA/LUCERNE patients
Stringent criteria (as actually applied in TENAYA/LUCERNE)**
Treatment change if ANY criteria are met (based on criteria used in pivotal trials)
OR
≥ 10 letters BCVA
loss vs highest BCVA
recorded over
previous 2 scheduled
visits, due to nAMD*
Share of patients assigned to >Q12W dosing
Assessment done at week 20
> 50 μm CST
increase vs avg.
OR
OR
CST over previous 2
scheduled visits
≥ 75 μm CST
increase vs lowest
CST recorded at
OR
either of previous 2
scheduled visits
22%
macular
hemorrhage*, due
to nAMD activity
Less stringent criteria (post hoc analysis)
Treatment change if ALL criteria are met
> 25 μm CST
increase vs week
Presence of new
4%
78%
>Q12W
Q8W
>5 letters BCVA
loss vs week 16
BCVA
AND
16 CST or new
macular
hemorrhage
96%
.
Ph III TENAYA/LUCERNE trial with stringent patient-centric criteria resulted in 22% of patients being allocated to Q8W dosing
Using less stringent criteria, only 4% of patients would have been assigned to Q8W dosing (post hoc analysis)
1 Heier et al. Lancet. 2022;399(10326):729-40; TENAYA (NCT03823287) & LUCERNE (NCT03823300); *per the investigator; **Additional patients with a missing Week 20 assessment were considered to have met disease activity criteria and were treated Q8W;
Q8W-every 8 weeks; BCVA-best-corrected visual acuity; nAMD-neovascular age-related macular degeneration; CST=central subfield thickness; Note: This analysis is not intended as a cross-trial comparison; This analysis cannot predict whether
faricimab-treated patients in TENAYA & LUCERNE would have achieved non-inferiority vs aflibercept 2mg if the treatment regimen had been modified; This analysis is not intended to state or imply long term efficacy or safety
33View entire presentation