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TENAYA and LUCERNE: Two-Year Results from the Phase 3 Neovascular Age-Related Macular Degeneration Trials of Faricimab with Treat-and-Extend Dosing in Year 2
Ophthalmology · Ağustos 2024
YÖKSİS Kayıtları
Two-Year Results from the Phase 3 Neovascular Age- Related Macular Degeneration Trials of Faricimab with Treat-and-Extend Dosing in Year 2
Ophthalmology · 2024 SCI-Expanded
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Makale Bilgileri
DergiOphthalmology
Yayın TarihiAğustos 2024
Cilt / Sayfa131 · 914-926
Scopus ID2-s2.0-85187901367
Erişim🔓 Açık Erişim
Özet
Purpose: To evaluate 2-year efficacy, durability, and safety of the bispecific antibody faricimab, which inhibits both angiopoietin-2 and VEGF-A. Design: TENAYA (ClinicalTrials.gov identifier, NCT03823287) and LUCERNE (ClinicalTrials.gov identifier, NCT03823300) were identically designed, randomized, double-masked, active comparator-controlled phase 3 noninferiority trials. Participants: Treatment-naive patients with neovascular age-related macular degeneration (nAMD) 50 years of age or older. Methods: Patients were randomized (1:1) to intravitreal faricimab 6.0 mg up to every 16 weeks (Q16W) or aflibercept 2.0 mg every 8 weeks (Q8W). Faricimab fixed dosing based on protocol-defined disease activity at weeks 20 and 24 up to week 60, followed up to week 108 by a treat-and-extend personalized treatment interval regimen. Main Outcome Measures: Efficacy analyses included change in best-corrected visual acuity (BCVA) from baseline at 2 years (averaged over weeks 104, 108, and 112) and proportion of patients receiving Q16W, every 12 weeks (Q12W), and Q8W dosing at week 112 in the intention-to-treat population. Safety analyses included ocular adverse events (AEs) in the study eye through study end at week 112. Results: Of 1326 patients treated across TENAYA/LUCERNE, 1113 (83.9%) completed treatment (n = 555 faricimab; n = 558 aflibercept). The BCVA change from baseline at 2 years was comparable between faricimab and aflibercept groups in TENAYA (adjusted mean change, +3.7 letters [95% confidence interval (CI), +2.1 to +5.4] and +3.3 letters [95% CI, +1.7 to +4.9], respectively; mean difference, +0.4 letters [95% CI, −1.9 to +2.8]) and LUCERNE (adjusted mean change, +5.0 letters [95% CI, +3.4 to +6.6] and +5.2 letters [95% CI, +3.6 to +6.8], respectively; mean difference, −0.2 letters [95% CI, −2.4 to +2.1]). At week 112 in TENAYA and LUCERNE, 59.0% and 66.9%, respectively, achieved Q16W faricimab dosing, increasing from year 1, and 74.1% and 81.2%, achieved Q12W or longer dosing. Ocular AEs in the study eye were comparable between faricimab and aflibercept groups in TENAYA (55.0% and 56.5% of patients, respectively) and LUCERNE (52.9% and 47.5% of patients, respectively) through week 112. Conclusions: Treat-and-extend faricimab treatment based on nAMD disease activity maintained vision gains through year 2, with most patients achieving extended dosing intervals. Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Yazarlar (100)
1
Arshad M. Khanani
ORCID: 0000-0001-8928-5599
2
Aachal Kotecha
3
Andrew Chang
4
Shih Jen Chen
5
Youxin Chen
6
Robyn Guymer
7
Jeffrey S. Heier
8
Frank G. Holz
9
Tomohiro Iida
10
Jane A. Ives
11
Jennifer Lim
12
Hugh Lin
13
Stephan Michels
14
Carlos Quezada Ruiz
15
Ursula Schmidt-Erfurth
16
David Silverman
17
Rishi Singh
18
Balakumar Swaminathan
19
Jeffrey R. Willis
20
Ramin Tadayoni
21
Ashkan Abbey
22
Elmira Abdulaeva
23
Prema Abraham
24
Alfredo Adan Civera
25
Hansjurgen Agostini
26
Arturo Alezzandrini
27
Virgil Alfaro
28
Arghavan Almony
29
Lebriz Altay
30
Payam Amini
31
Andrew Antoszyk
32
Etelka Aradi
33
Luis Arias
34
Jennifer Arnold
35
Riaz Asaria
36
Sergei Astakhov
37
Yuri S. Astakhov
38
Carl C. Awh
39
Chandra Balaratnasingam
40
Sanjiv Banerjee
41
Caroline R. Baumal
42
Matthias Becker
43
Rubens Belfort
44
Galina Bratko
45
William Z. Bridges
46
Jamin Brown
47
David M. Brown
48
Maria Budzinskaya
49
Sylvia Buffet
50
Stuart Burgess
51
Iksoo Byon
52
Carlo Cagini
53
Jorge Calzada
54
Stone Cameron
55
Peter Campochiaro
56
John Carlson
57
Angela Carneiro
58
Clement Chan
59
Emmanuel Chang
60
Daniel Chao
61
Nauman Chaudhry
62
Caroline Chee
63
Andrew Cheek
64
San Ni Chen
65
Gemmy Cheung
66
Saradha Chexal
67
Mark Chittum
68
David Chow
69
Abosede Cole
70
Brian Connolly
71
Pierre Loic Cornut
72
Stephen Couvillion
73
Carl Danzig
74
Vesselin Daskalov
75
Amr Dessouki
76
Francois Devin
77
Michael Dollin
78
Rosa Dolz
79
Louise Downey
80
Richard Dreyer
81
Pravin Dugel
82
David Eichenbaum
83
Bora Eldem
84
Robert Engstrom
85
Joan Josep Escobar
86
Nicole Eter
87
David W. Faber
88
Naomi Falk
89
Leonard Feiner
90
Alvaro Fernandez Vega
91
Philip Ferrone
92
Marta Figueroa
93
Howard Fine
94
Mitchell Fineman
95
Gregory M. Fox
96
Catherine Francais
97
Pablo Franco
98
Samantha Fraser-Bell
99
Nicholas Fung
100
Federico Furno Sola
Anahtar Kelimeler
Angiopoietin-2
Faricimab
Neovascular age-related macular degeneration
Vascular endothelial growth factor A
Vascular stability
Kurumlar
Cleveland Clinic Florida
Fort Lauderdale United States
Eye Clinic Zurich West
Zurich Switzerland
Genentech, Inc
San Francisco United States
Hoffmann-La Roche Ltd
Mississauga Canada
Medizinische Universität Wien
Vienna Austria
National Yang Ming Chiao Tung University
Hsinchu Taiwan
Ophthalmic Consultants of Boston
Boston United States
Peking Union Medical College Hospital
Beijing China
Roche Products Limited UK
Welwyn Garden City United Kingdom
The University of Sydney
Sydney Australia
Tokyo Women's Medical University
Tokyo Japan
Universität Bonn
Bonn Germany
Universität Zürich
Zurich Switzerland
Université Paris Cité
Paris France
University of Illinois at Chicago
Chicago United States
University of Melbourne
Melbourne Australia
University of Nevada, Reno School of Medicine
Reno United States
Metrikler
15
Atıf
100
Yazar
5
Anahtar Kelime