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

被引：10

作者：

Alegre, Adrian ^{[1
]}

Benzo, Gonzalo ^{[1
]}

Alonso, Rafael ^{[2
]}

Martinez-Lopez, Joaquin ^{[2
]}

Jimenez-Ubieto, Ana ^{[2
]}

Cuellar, Clara ^{[2
]}

Askari, Elham ^{[3
]}

Prieto, Elena ^{[3
]}

Alaez, Concepcion ^{[4
]}

Aguado, Beatriz ^{[1
]}

Velasco, Alberto ^{[5
]}

Krsnik, Isabel ^{[6
]}

Bocanegra, Ana ^{[6
]}

Llorente, Laura ^{[7
]}

Munoz-Linares, Cristina ^{[8
]}

Morales, Ana ^{[9
]}

Gimenez, Eugenio ^{[10
]}

Iglesias, Rebeca ^{[11
]}

Martinez-Chamorro, Carmen ^{[12
]}

Alonso, Aranzazu ^{[13
]}

Jimenez-Montes, Carmen ^{[1
]}

Blanchard, Maria J. ^{[14
]}

机构：

[1] Hosp Univ La Princesa, Madrid, Spain

[2] Hosp Univ 12 Octubre, Madrid, Spain

[3] Fdn Jimenez Diaz, Madrid, Spain

[4] Hosp HLA Univ Moncloa, Madrid, Spain

[5] Hosp Rey Juan Carlos, Madrid, Spain

[6] Hosp U Puerta Hierro, Madrid, Spain

[7] Hosp Univ HM Sanchinarro, Madrid, Spain

[8] Hosp Univ Henares, Madrid, Spain

[9] Hosp Univ Torrejon, Madrid, Spain

[10] Hosp Univ Infanta Sofia, Madrid, Spain

[11] MD Anderson Canc Ctr Madrid, Madrid, Spain

[12] Hosp Univ Quiron Pozuelo, Madrid, Spain

[13] Hosp Ruber Juan Bravo, Madrid, Spain

[14] Hosp Univ Ramon y Cajal, Madrid, Spain

来源：

ONCOLOGY AND THERAPY | 2023年 / 11卷 / 01期

关键词：

Triple-class relapsed and refractory multiple myeloma; Belantamab mafodotin; Real-world outcomes; Effectiveness; Safety; ANTIBODIES;

D O I：

10.1007/s40487-022-00212-5

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

IntroductionBelantamab 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). MethodsWe conducted an observational, retrospective, multicenter study including RRMM patients who received & GE; 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). ResultsThirty-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% (& GE; 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 & GE; 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% & GE; G3) included keratopathy (51.5%; 21.2% & GE; 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%). ConclusionsBM showed relevant anti-myeloma activity in RRMM with a manageable safety profile. These results corroborate those observed in the BM pivotal trial.

引用

页码：83 / 96

页数：14

共 32 条

[1] Compassionate Use of Belantamab Mafodotin for Treatment of Patients with Relapsed/Refractory Multiple Myeloma Heavily Treated. Spanish Experience [J].