Pharma Update
Roche
Vabysmo: Disease activity criteria chosen affect durability outcomes
Vabysmo nAMD trials use vision or anatomical disease activity criteria, reflecting clinical practice¹
Different ≥Q12W disease criteria as applied to Vabysmo or aflibercept 8 mg patients*
aflibercept 8mg
ASRS
SEATTLE
Vabysmo
Share of patients assigned to ≥Q12W dosing
Assessment done at week 20
Share of patients assigned to ≥Q12W dosing
Stringent criteria (as actually applied in our clinical trials)
Treatment change if ANY criteria are met (based on criteria used in
pivotal trials)
22%
"OR"
criteria
53%
47% Ph II CANDELA
(wk 44)
A
OR
B
OR
C OR D
OR E
78%
Less stringent criteria (post hoc analysis**)
Treatment change if ALL criteria are met
F AND
G
4%
>Q12W
Q8W
96%
"AND"
criteria
83%
>Q12W
Q8W
17%
Ph III PULSAR
(wk 48)
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. Zarbin et al. ASRS, 2023; *Criteria: A=> 5 letters BCVA loss vs avg. BCVA over previous 2 scheduled visits, due to nAMD, B=> 10 letters BCVA loss vs highest BCVA recorded over previous 2 scheduled visits, due to nAMD; C=> 50 μm CST increase vs avg. CST over previous 2 scheduled
visits; D=≥ 75 μm CST increase vs lowest CST recorded at either of previous 2 scheduled visits; E-Presence of new macular hemorrhage*, due to nAMD activity; F->5 letters BCVA loss vs week 16 BCVA; G=> 25 μm CST increase vs week 16 CST or new macular hemorrhage; **Post-hoc
analysis of patients dosing eligibility at week 20, patients not actually assigned based on 'and' criteria in TENAYA/LUCERNE; 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/8mg if the treatment regimen had been modified; additional patients with a missing Week 20 assessment were considered to have met disease activity criteria and were treated Q8W; Q8W=every 8 weeks
49
49View entire presentation