Takahashi Kanji, Cheung Chui Ming Gemmy, Iida Tomohiro, Lai Timothy Y Y, Ohji Masahito, Yanagi Yasuo, Kawano Mika, Ohsawa Shino, Suzuki Tomoyuki, Kotecha Aachal, Lin Hugh, Patel Vaibhavi, Swaminathan Balakumar, Lee Won Ki
Department of Ophthalmology, Kansai Medical University, School of Medicine, 2-5-1 Shinmachi, Hirakata City, Osaka, 573-1191, Japan.
Singapore Eye Research Institute, Singapore National Eye Centre, Duke-NUS Medical School, National University of Singapore, Singapore, Singapore.
Graefes Arch Clin Exp Ophthalmol. 2023 Nov;261(11):3125-3137. doi: 10.1007/s00417-023-06071-8. Epub 2023 Jun 9.
To evaluate 1-year efficacy, durability, and safety of faricimab among patients from Asian countries in the TENAYA/LUCERNE trials of neovascular age-related macular degeneration (nAMD).
Treatment-naïve patients with nAMD were randomly assigned (1:1) to faricimab 6.0 mg up to every 16 weeks (Q16W), based on disease activity at weeks 20 and 24, or aflibercept 2.0 mg Q8W. The primary endpoint was change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44, and 48.
In the pooled TENAYA/LUCERNE trials, there were 120 (9.0%) and 1209 (91.0%) patients in the Asian (faricimab n = 61; aflibercept n = 59) and non-Asian country (faricimab n = 604; aflibercept n = 605) subgroups, respectively. In the Asian country subgroup, mean BCVA change from baseline at the primary endpoint visits was 7.1 (95% CI, 4.3-9.8) letters with faricimab and 7.2 (4.4-10.0) letters with aflibercept. In non-Asian country patients, mean vision gains were 6.1 (5.2-7.1) and 5.7 (4.8-6.7) letters with faricimab and aflibercept, respectively. At week 48, 59.6% of Asian country patients in the faricimab group achieved Q16W dosing (vs. 43.9% non-Asian) and 91.2% achieved ≥ Q12W dosing (vs. 77.5% non-Asian). Central subfield thickness reductions were similar between the subgroups, with meaningful and similar reductions from baseline observed at the primary endpoint visits and over time. Faricimab was well tolerated in both subgroups, with an acceptable safety profile.
Consistent with the global TENAYA/LUCERNE findings, faricimab up to Q16W showed sustained visual and anatomical benefits in patients with nAMD from Asian and non-Asian countries.
ClinicalTrials.gov identifier: NCT03823287 (TENAYA); NCT03823300 (LUCERNE). Date of registration: January 30, 2019.
在新生血管性年龄相关性黄斑变性（nAMD）的TENAYA/LUCERNE试验中，评估法西单抗在亚洲国家患者中的1年疗效、持久性和安全性。
初治nAMD患者按1:1随机分配，根据第20周和第24周的疾病活动情况，每16周接受一次6.0mg法西单抗治疗（Q16W），或每8周接受一次2.0mg阿柏西普治疗。主要终点是第40、44和48周平均最佳矫正视力（BCVA）较基线的变化。
在汇总的TENAYA/LUCERNE试验中，亚洲（法西单抗n = 61；阿柏西普n = 59）和非亚洲国家（法西单抗n = 604；阿柏西普n = 605）亚组分别有120例（9.0%）和1209例（91.0%）患者。在亚洲国家亚组中，主要终点访视时法西单抗组BCVA较基线的平均变化为7.1（95%CI，4.3 - 9.8）字母，阿柏西普组为7.2（4.4 - 10.0）字母。在非亚洲国家患者中，法西单抗和阿柏西普组的平均视力提高分别为6.1（5.2 - 7.1）和5.7（4.8 - 6.7）字母。在第48周，法西单抗组59.6%的亚洲国家患者实现了Q16W给药（非亚洲患者为43.9%），91.2%的患者实现了≥Q12W给药（非亚洲患者为77.5%）。亚组间中心子野厚度减少情况相似，在主要终点访视时及随访期间均观察到从基线有显著且相似的减少。两个亚组中法西单抗的耐受性均良好，安全性可接受。
与全球TENAYA/LUCERNE研究结果一致，每16周一次的法西单抗在亚洲和非亚洲国家的nAMD患者中显示出持续的视力和解剖学益处。
ClinicalTrials.gov标识符：NCT03823287（TENAYA）；NCT
