Roche Pharmaceutical Development and Sales Overview
Vabysmo: Disease criteria chosen impact patient allocation
Vabysmo nAMD trials use disease criteria reflective of clinical practice 1
Different ≥Q12W disease criteria as applied to TENAYA/LUCERNE patients
Stringent criteria**
Treatment change if ANY criteria are met (based on criteria used in pivotal trials)
VABYSMO
Share of patients on ≥Q12W dosing
Assessment done at week 20
≥ 5 letters BCVA
loss vs avg. BCVA
over previous 2
scheduled visits, due
to nAMD*
≥ 10 letters BCVA
loss vs highest
BCVA recorded over
OR
OR
> 50 μm CST
increase vs avg.
OR
previous 2
scheduled visits, due
CST over previous 2
≥ 75 μm CST
increase vs lowest
CST recorded at
either of previous 2
Presence of new
OR
scheduled visits
macular
hemorrhage*, due
to nAMD activity
scheduled visits
to nAMD*
Less stringent criteria
Treatment change if ALL criteria are met
>5 letters BCVA
loss vs week 16
BCVA
AND
> 25 μm CST
increase vs week 16
CST or new macular
hemorrhage
22%
4%
Roche
78%
>Q12W
Q8W
96%
•
Ph III TENAYA/LUCERNE trial with stringent patient-centric criteria resulted in 22% of patients being allocated to Q8W dosing
•
Utilizing less stringent criteria only 4% of patients would have resulted in 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
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