Mihir N Patel, Susan C Locke, Caroline Falvey, Jesse D Troy, Kris W Herring, Amanda Bolgioni-Smith, Cherie Elcock, Laura Iadeluca, Cristiana Costa Chase, Cristina Gasparetto, Mark S Newman, Thomas W LeBlanc
{"title":"贝兰他单抗马福多汀在复发和/或难治性多发性骨髓瘤患者中的治疗模式、疗效和耐受性:一项现实世界分析。","authors":"Mihir N Patel, Susan C Locke, Caroline Falvey, Jesse D Troy, Kris W Herring, Amanda Bolgioni-Smith, Cherie Elcock, Laura Iadeluca, Cristiana Costa Chase, Cristina Gasparetto, Mark S Newman, Thomas W LeBlanc","doi":"10.1016/j.clml.2025.04.008","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Patients and methods: </strong>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).</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusion: </strong>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.</p><p><strong>Registration: </strong>CLINICALTRIALS.GOV: NCT05986682.</p>","PeriodicalId":10348,"journal":{"name":"Clinical Lymphoma, Myeloma & Leukemia","volume":" ","pages":""},"PeriodicalIF":2.7000,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Treatment Patterns, Efficacy, and Tolerability of Belantamab Mafodotin in Patients With Relapsed and/or Refractory Multiple Myeloma: A Real-World Analysis.\",\"authors\":\"Mihir N Patel, Susan C Locke, Caroline Falvey, Jesse D Troy, Kris W Herring, Amanda Bolgioni-Smith, Cherie Elcock, Laura Iadeluca, Cristiana Costa Chase, Cristina Gasparetto, Mark S Newman, Thomas W LeBlanc\",\"doi\":\"10.1016/j.clml.2025.04.008\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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.</p><p><strong>Patients and methods: </strong>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).</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusion: </strong>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.</p><p><strong>Registration: </strong>CLINICALTRIALS.GOV: NCT05986682.</p>\",\"PeriodicalId\":10348,\"journal\":{\"name\":\"Clinical Lymphoma, Myeloma & Leukemia\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.7000,\"publicationDate\":\"2025-04-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Lymphoma, Myeloma & Leukemia\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.clml.2025.04.008\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"HEMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Lymphoma, Myeloma & Leukemia","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.clml.2025.04.008","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEMATOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
目的:Belantamab mafodotin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。需要更多关于其治疗模式、疗效和现实环境耐受性的数据。患者和方法:这项单点回顾性研究调查了30名在杜克癌症研究所接受治疗的多发性骨髓瘤患者,他们在2020年8月5日至2022年11月22日期间开始贝兰他单抗马弗多汀单药治疗。我们描述了基线临床特征、疾病反应(根据国际骨髓瘤工作组[IMWG]标准,尽可能提供骨髓活检数据)、贝兰他单抗治疗模式和眼部不良事件(根据角膜病变视力[KVA]量表)。结果:在30例患者中,治疗线的中位数为4条,20例患者(87%)为三难治性/四难治性/五难治性,7例患者(23%)为高危细胞遗传学(根据IMWG标准)。总有效率为67%。22例(73%)患者出现进展;中位无进展生存期为9.5个月(95% CI 6.6-15.6)。3年随访时,中位总生存期未达到。19例患者(63%)出现剂量减少;65%是眼部不良事件,30%是血液学不良事件。周期延迟28例(93%);85%是由于眼部不良事件。角膜病变(任何级别)28例(93%);2%的事件≥3级。视力(任何级别)改变27例(90%);3.3%的事件为≥3级。4例(13%)因眼毒性而停止治疗。结论:尽管可控性角膜病变的发生率很高,但这些数据表明,在剂量/周期调整的较长时间内,贝兰他单马福多汀对RRMM患者有益。注册:临床试验。政府:NCT05986682。
Treatment Patterns, Efficacy, and Tolerability of Belantamab Mafodotin in Patients With Relapsed and/or Refractory Multiple Myeloma: A Real-World Analysis.
Purpose: 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.
Patients and methods: 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).
Results: 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%).
Conclusion: 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.
期刊介绍:
Clinical Lymphoma, Myeloma & Leukemia is a peer-reviewed monthly journal that publishes original articles describing various aspects of clinical and translational research of lymphoma, myeloma and leukemia. Clinical Lymphoma, Myeloma & Leukemia is devoted to articles on detection, diagnosis, prevention, and treatment of lymphoma, myeloma, leukemia and related disorders including macroglobulinemia, amyloidosis, and plasma-cell dyscrasias. The main emphasis is on recent scientific developments in all areas related to lymphoma, myeloma and leukemia. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.