Patel Mihir N, Locke Susan C, Falvey Caroline, Troy Jesse D, Herring Kris W, Bolgioni-Smith Amanda, Elcock Cherie, Iadeluca Laura, Costa Chase Cristiana, Gasparetto Cristina, Newman Mark S, LeBlanc Thomas W
Duke University School of Medicine, Durham, NC.
Duke Cancer Institute, Durham, NC.
Clin Lymphoma Myeloma Leuk. 2025 Aug;25(8):e570-e579.e4. doi: 10.1016/j.clml.2025.04.008. Epub 2025 Apr 15.
Belantamab mafodotin is an anti-B cell maturation antigen (BCMA) immunoconjugate for patients with relapsed/refractory multiple myeloma (RRMM). Additional data on its treatment patterns, efficacy, and tolerability in real-world settings are needed.
This single-site, retrospective study examined 30 adults with multiple myeloma receiving care at Duke Cancer Institute who began belantamab mafodotin monotherapy between 8/5/2020 and 11/22/2022. We described baseline clinical characteristics, disease response (per International Myeloma Working Group [IMWG] criteria, as possible given available bone marrow biopsy data), belantamab mafodotin treatment patterns, and ocular adverse events (per the Keratopathy Visual Acuity [KVA] scale).
Across 30 patients, the median number of lines of therapy was 4, 20 patients (87%) were triple-/quad-/penta-refractory, and 7 (23%) had high-risk cytogenetics (per IMWG criteria). Overall response rate was 67%. Progression occurred in 22 patients (73%); median progression-free survival was 9.5 months (95% CI 6.6-15.6). Median overall survival was not reached as of 3-year follow-up. Dose reduction occurred in 19 patients (63%); 65% were due to ocular adverse events, 30% hematologic adverse events. Cycle delay occurred in 28 (93%); 85% were due to ocular adverse events. Keratopathy (any grade) occurred in 28 (93%); 2% of events were grade ≥3. Visual acuity change (any grade) occurred in 27 (90%); 3.3% of events were grade ≥3. Treatment discontinuation from ocular toxicity occurred in 4 (13%).
Despite a high incidence of manageable keratopathy, these data demonstrate benefit in belantamab mafodotin in patients with RRMM over an extended time amid dose/cycle modifications.
CLINICALTRIALS.GOV: NCT05986682.
贝兰他单抗莫福汀是一种用于复发/难治性多发性骨髓瘤(RRMM)患者的抗B细胞成熟抗原(BCMA)免疫偶联物。需要更多关于其在真实世界中的治疗模式、疗效和耐受性的数据。
这项单中心回顾性研究纳入了30例在杜克癌症研究所接受治疗的成年多发性骨髓瘤患者,他们于2020年8月5日至2022年11月22日开始接受贝兰他单抗莫福汀单药治疗。我们描述了基线临床特征、疾病缓解情况(根据国际骨髓瘤工作组[IMWG]标准,尽可能结合可用的骨髓活检数据)、贝兰他单抗莫福汀的治疗模式以及眼部不良事件(根据角膜病变视力[KVA]量表)。
30例患者中,治疗线数的中位数为4,20例患者(87%)为三重/四重/五重难治性,7例(23%)具有高危细胞遗传学特征(根据IMWG标准)。总缓解率为67%。22例患者(73%)出现疾病进展;无进展生存期的中位数为9.5个月(95%CI 6. 在3年随访时,总生存期的中位数尚未达到。19例患者(63%)出现剂量减少;65%是由于眼部不良事件引起,30%是由于血液学不良事件引起。28例患者(93%)出现周期延迟;85%是由于眼部不良事件引起。28例患者(93%)出现角膜病变(任何级别);2%的事件为≥3级。27例患者(90%)出现视力变化(任何级别);3.3%的事件为≥3级。4例患者(13%)因眼部毒性而停止治疗。
尽管可管理的角膜病变发生率较高,但这些数据表明,在剂量/周期调整的情况下,贝兰他单抗莫福汀在RRMM患者中长期使用具有益处。
CLINICALTRIALS.GOV:NCT05986682。