Roche Pharmaceutical Development and Sales Overview
Vabysmo: Improved overall disease control in DME
Treat & extend study design well-aligned with clinical practice
Ph III trial design in DME (YOSEMITE/RHINE)
VABYSMO
Ph III (YOSEMITE/RHINE) 2 year results
YOSEMITE/RHINE Pooled
•
.
YOSEMITE & RHINE
Phase 3, randomized, double-masked, active comparator-controlled trials
Patients with center-involving DME (CST ≥ 325 μm)a
BCVA 25-73 ETDRS letters (Snellen BCVA-20/320-20/40) b
Anti-VEGF treatment-naïve
or previously treated patients
with DMEC
(1 eye per patient)
YOSEMITE: N=940
RHINE: N 951
Faricimab
6.0 mg Q8W
Faricimab
6.0 mg PTI
Aflibercept
2.0 mg Q8W
Primary Endpointd
Study End
D1 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100
Time, Weeks
Active treatment (faricimab 6.0 mg or aflibercept 2.0 mg)
Sham
PTI visit (sham or faricimab 6.0 mg)
Final study visit
Adjusted Mean BCVA
Change
From Baseline, ETDRS
Letters
Adjusted Mean
CST Change
From Baseline, um
12086420
Average of weeks 92-100a
Faricimab Q8W: +10.8 ETDRS letters
Faricimab PTI: +10.4 ETDRS letters
Aflibercept Q8W: +10.3 ETDRS letters
0
8
16
24
32
40
48
56
Time, Weeks
64
72
80
88
96
0
-50
-100
-150
-200
-250
0
8
16
24
32
40
Aflibercept Q8W (n=627)
Average of weeks 92-100a
Faricimab Q8W: -209.4 μm*
Faricimab PTI: -201.0 μm*
Aflibercept Q8W:-190.9 μm
48
Time, Weeks
Faricimab Q8W (n=632)
56
64
72
80
88
96
Faricimab PTI (n=632)
First time treat & extend principals were consistently applied in a randomized Ph III setting aligned with clinical practice
Share of patients on ≥Q12W dosing at 78% in year 2, with share of patients on Q16W dosing improving to 62% from 52% in year 1
YOSEMITE (NCT03622580)/RHINE (NCT03622593). Test for superiority: * Nominal P < 0.05 versus aflibercept Q8W. P values are nominal and not adjusted for multiplicity; a CST was measured as the distance from the internal limiting membrane to
Bruch's membrane. b BCVA was measured using the ETDRS visual acuity at a starting distance of 4 m. c Previously anti-VEGF-treated eyes (treated>= 3 months before day 1) were limited to 25% of the total enrolment. d Primary efficacy endpoint:
adjusted mean BCVA change from baseline at year 1, averaged over weeks 48, 52 and 56. BCVA=best corrected visual acuity; CST=central subfield thickness; DME-diabetic macular edema; ETDRS-early diabetic retinopathy study;
PTI=personalized treatment interval; Q8W-every 8 weeks; Eylea (aflibercept) is a registered trademark/product of Regeneron
Roche
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