Sierra Eye Associates and the University of Nevada, Reno, School of Medicine, Reno, Nevada.
Roche Products, Ltd., Welwyn Garden City, United Kingdom.
Ophthalmology. 2024 Aug;131(8):914-926. doi: 10.1016/j.ophtha.2024.02.014. Epub 2024 Feb 19.
To evaluate 2-year efficacy, durability, and safety of the bispecific antibody faricimab, which inhibits both angiopoietin-2 and VEGF-A.
TENAYA (ClinicalTrials.gov identifier, NCT03823287) and LUCERNE (ClinicalTrials.gov identifier, NCT03823300) were identically designed, randomized, double-masked, active comparator-controlled phase 3 noninferiority trials.
Treatment-naive patients with neovascular age-related macular degeneration (nAMD) 50 years of age or older.
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.
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.
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.
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.
评估抑制血管生成素-2 和 VEGF-A 的双特异性抗体 faricimab 的 2 年疗效、持久性和安全性。
TENAYA（ClinicalTrials.gov 标识符，NCT03823287）和 LUCERNE（ClinicalTrials.gov 标识符，NCT03823300）是设计相同的、随机的、双盲的、活性对照的 3 期非劣效性试验。
未经治疗的年龄相关性黄斑变性（nAMD）患者，年龄 50 岁及以上。
患者随机（1:1）接受玻璃体腔内 faricimab 6.0 mg，每 16 周（Q16W）或 aflibercept 2.0 mg 每 8 周（Q8W）。根据第 20 周和第 24 周的方案定义的疾病活动情况，对 faricimab 进行固定剂量治疗，直至第 60 周，随后在第 108 周根据个性化治疗间隔方案进行治疗和延长。
疗效分析包括在第 2 年（在第 104、108 和 112 周的平均值）时最佳矫正视力（BCVA）从基线的变化以及在第 112 周时接受 Q16W、每 12 周（Q12W）和 Q8W 剂量的意向治疗人群中的比例。安全性分析包括在第 112 周研究眼的眼部不良事件（AE）。
在 TENAYA/LUCERNE 治疗的 1326 例患者中，1113 例（83.9%）完成了治疗（n=555 例 faricimab；n=558 例 aflibercept）。在 TENAYA 中，与 aflibercept 组相比，faricimab 组的 BCVA 从基线到 2 年的变化具有可比性（调整后的平均变化分别为+3.7 个字母[95%置信区间（CI），+2.1 至+5.4]和+3.3 个字母[95%CI，+1.7 至+4.9]；平均差异，+0.4 个字母[95%CI，-1.9 至+2.8]）和 LUCERNE（调整后的平均变化分别为+5.0 个字母[95%CI，+3.4 至+6.6]和+5.2 个字母[95%CI，+3.6 至+6.8]；平均差异，-0.2 个字母[95%CI，-2.4 至+2.1]）。在 TENAYA 和 LUCERNE 的第 112 周，分别有 59.0%和 66.9%的患者达到了 Q16W faricimab 剂量，从第 1 年开始增加，分别有 74.1%和 81.2%的患者达到了 Q12W 或更长的剂量。在第 112 周时，TENAYA（分别为 55.0%和 56.5%的患者）和 LUCERNE（分别为 52.9%和 47.5%的患者）的研究眼的眼部 AE 在 faricimab 和 aflibercept 组之间具有可比性。
基于 nAMD 疾病活动的 faricimab 治疗的延长治疗方案维持了 2 年的视力改善，大多数患者实现了延长的给药间隔。
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