Roche Pharmaceutical Development and Sales Overview
Vabysmo: 2 year nAMD data presented at ASRS
Strong BCVA and CST results sustained over 2 years
Ph III trial design in nAMD (TENAYA/LUCERNE)
VABYSMO
Ph III (TENAYA/LUCERNE) 2 year results
R 1:1
Disease Activity
Assessment
Initial dosing
Faricimab 6.0 mg
up to Q16W
Active disease at week 24
Active disease at week 20
Initial dosing
Aflibercept 2.0 mg
Q8W
Primary Endpointa
Change in BCVA from
baseline averaged over the
week 40, 44, and 48 visits
0 4 8
12
16 20
24
28
32
36
40
44
48
52
56
Time, Weeks
Aflibercept 2.0 mg
Faricimab 6.0 mg
Sham
Final Visit
Year 2
ongoing
PTI
Continue
dosing
108
112
ITT Population
Adjusted Mean CST Change
From Baseline, μm
From
Adjaseline, ETDRS Letters
BCVA Change
0 4
0
-50
-100
-150
-200
0 4
TENAYA/LUCERNE Pooled
I
Roche
ASRS
Average of
weeks 104-112a
1 1 1
I
+ 4.4 letters
1
+ 4.3 letters
8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 104 108 112
8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 104 108 112
Time, Weeks
Aflibercept Q8W (n = 664)
Faricimab up to Q16W (n = 665)
.
•
•
Disease activity criteria at week 20 and 24 used to allocate patients to treatment intervals (Q8W or Q12W or Q16W) for the remainder of year 1
During year 2, Vabysmo patients could be reallocated to personalized treatment intervals
Share of patients on ≥Q12W dosing at 78% in year 2, with share of patients on Q16W dosing improving to 63% from 45% in year 1
Average of
weeks 104-112a
- 148.4 μm
144.0 μm
Khanani A.M. et al., ASRS conference 2022; TENAYA (NCT03823287)/LUCERNE (NCT03823300): a BCVA was measured using the ETDRS visual acuity chart at a starting distance of 4 m; BCVA-best-corrected visual acuity;
nAMD=neovascular age-related macular degeneration; CST-central subfield thickness; ETDRS-early diabetic retinopathy study; Q8W-every 8 weeks; ITT-intention to treat; Eylea (aflibercept) is a registered trademark/product of
Regeneron
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