Real-World Outcomes of Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results of a Spanish Expanded Access Program (EAP).

IF 3.2 Q2 ONCOLOGY

Oncology and Therapy Pub Date : 2023-03-01 Epub Date: 2022-12-12 DOI:10.1007/s40487-022-00212-5

Adrián Alegre, Gonzalo Benzo, Rafael Alonso, Joaquín Martínez-López, Ana Jimenez-Ubieto, Clara Cuéllar, Elham Askari, Elena Prieto, Concepción Aláez, Beatriz Aguado, Alberto Velasco, Isabel Krsnik, Ana Bocanegra, Laura Llorente, Cristina Muñoz-Linares, Ana Morales, Eugenio Giménez, Rebeca Iglesias, Carmen Martínez-Chamorro, Aránzazu Alonso, Carmen Jiménez-Montes, María J Blanchard

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引用次数: 0

Abstract

Introduction: Belantamab mafodotin (BM) is a new anti-BCMA antibody-drug conjugate, recently approved for triple-class relapsed and refractory multiple myeloma (RRMM). We assessed real-world outcomes with BM in patients under the Spanish Expanded Access Program (EAP).

Methods: We conducted an observational, retrospective, multicenter study including RRMM patients who received ≥ 1 dose of BM (Nov 2019 to Jun 2021). The primary endpoint was overall response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and incidence of treatment-emergent adverse events (TEAEs).

Results: Thirty-three patients were included with a median of 70 years of age (range, 46-79 years). Median time from diagnosis was 71 months (range, 10-858 months). Median prior lines was 5 (range, 3-8 lines); 90% of patients were triple-/quad-/penta-refractory; 48% showed high-risk cytogenetics. Median BM doses was 3 (range 1-16 doses), with a median follow-up of 11 months (6-15 months). ORR was 42.2% (≥ VGPR, 18.2%). Median PFS was 3 months (95% CI 0.92-5.08) in the overall population, and 11 months (HR 0.26; 95% CI 0.10-0.68) for patients who achieved ≥ PR. PFS was not significantly different according to age, cytogenetic risk, and prior therapy lines. OS was 424 days (95% CI 107-740). Non-hematological TEAEs (57.6% of patients; 30.3% ≥ G3) included keratopathy (51.5%; 21.2% ≥ G3) and patient-reported vision-related symptoms (45.5%). Keratopathy was resolved in 70.6% of patients. G3 hematological TEAEs was 18.2%, thrombocytopenia (21.2%). Dose reductions due to TEAEs: 30.3%; delays: 36.4%. Treatment discontinuation causes: progression (54.5%), toxicity (non-ocular; 6%/ocular; 6% /ocular + non-ocular toxicity; 3%), death (6%), and patient's decision (3%).

Conclusions: BM showed relevant anti-myeloma activity in RRMM with a manageable safety profile. These results corroborate those observed in the BM pivotal trial.

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Belantamab Mafodotin治疗复发/难治性多发性骨髓瘤(RRMM)的实际结果:西班牙扩展准入计划(EAP)的初步结果

Belantamab mafodotin (BM)是一种新的抗bcma抗体-药物偶联物，最近被批准用于三级复发和难治性多发性骨髓瘤(RRMM)。我们评估了西班牙扩大准入计划(EAP)下BM患者的实际结果。方法:我们进行了一项观察性、回顾性、多中心研究，包括接受≥1剂量BM的RRMM患者(2019年11月至2021年6月)。主要终点是总缓解率(ORR)。次要终点是无进展生存期(PFS)、总生存期(OS)和治疗不良事件(teae)的发生率。结果:纳入33例患者，中位年龄70岁(范围46-79岁)。中位诊断时间为71个月(范围10-858个月)。既往行数中位数为5行(范围3-8行);90%的患者为三难治性/四难治性/五难治性;48%为高危细胞遗传学。中位剂量为3剂(范围1-16剂)，中位随访时间为11个月(6-15个月)。ORR为42.2%(≥VGPR, 18.2%)。中位PFS为3个月(95% CI 0.92-5.08)， 11个月(HR 0.26;95% CI 0.10-0.68)，达到≥PR的患者。PFS在年龄、细胞遗传风险和既往治疗方面没有显著差异。OS为424天(95% CI 107-740)。非血液学teae (57.6%);30.3%≥G3)包括角膜病变(51.5%;21.2%≥G3)和患者报告的视力相关症状(45.5%)。70.6%的患者角膜病变得到缓解。G3血液学teae为18.2%，血小板减少症为21.2%。teae引起的剂量减少:30.3%;延迟:36.4%。停药原因:进展(54.5%)，毒性(非眼毒性;6% /眼;6% /眼+非眼毒性;3%)、死亡(6%)和患者决定(3%)。结论:BM在RRMM中显示出相关的抗骨髓瘤活性，并且具有可控的安全性。这些结果证实了BM关键试验中观察到的结果。

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来源期刊

Oncology and Therapy ONCOLOGY-

CiteScore

3.40

自引率

0.00%

发文量

审稿时长

6 weeks

期刊介绍： Now indexed in PubMed Aims and Scope Oncology and Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Oncology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. 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