TY - JOUR
T1 - TENAYA and LUCERNE
T2 - Two-Year Results from the Phase 3 Neovascular Age-Related Macular Degeneration Trials of Faricimab with Treat-and-Extend Dosing in Year 2
AU - TENAYA and LUCERNE Investigators
AU - Khanani, Arshad M.
AU - Kotecha, Aachal
AU - Chang, Andrew
AU - Chen, Shih Jen
AU - Chen, Youxin
AU - Guymer, Robyn
AU - Heier, Jeffrey S.
AU - Holz, Frank G.
AU - Iida, Tomohiro
AU - Ives, Jane A.
AU - Lim, Jennifer I.
AU - Lin, Hugh
AU - Michels, Stephan
AU - Quezada Ruiz, Carlos
AU - Schmidt-Erfurth, Ursula
AU - Silverman, David
AU - Singh, Rishi
AU - Swaminathan, Balakumar
AU - Willis, Jeffrey R.
AU - Tadayoni, Ramin
AU - Abbey, Ashkan
AU - Abdulaeva, Elmira
AU - Abraham, Prema
AU - Adan Civera, Alfredo
AU - Agostini, Hansjurgen
AU - Alezzandrini, Arturo
AU - Alfaro, Virgil
AU - Almony, Arghavan
AU - Altay, Lebriz
AU - Amini, Payam
AU - Antoszyk, Andrew
AU - Aradi, Etelka
AU - Arias, Luis
AU - Arnold, Jennifer
AU - Asaria, Riaz
AU - Astakhov, Sergei
AU - Astakhov, Yury
AU - Awh, Carl C.
AU - Balaratnasingam, Chandra
AU - Banerjee, Sanjiv
AU - Baumal, Caroline
AU - Becker, Matthias
AU - Belfort, Rubens
AU - Bratko, Galina
AU - Bridges, William Z.
AU - Brown, Jamin
AU - Brown, David M.
AU - Budzinskaya, Maria
AU - Buffet, Sylvia
AU - Ito, Yasuki
N1 - Publisher Copyright:
© 2024 American Academy of Ophthalmology
PY - 2024/8
Y1 - 2024/8
N2 - 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.
AB - 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.
KW - Angiopoietin-2
KW - Faricimab
KW - Neovascular age-related macular degeneration
KW - Vascular endothelial growth factor A
KW - Vascular stability
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U2 - 10.1016/j.ophtha.2024.02.014
DO - 10.1016/j.ophtha.2024.02.014
M3 - Article
C2 - 38382813
AN - SCOPUS:85187901367
SN - 0161-6420
VL - 131
SP - 914
EP - 926
JO - Ophthalmology
JF - Ophthalmology
IS - 8
ER -