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

Autor: 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, Grupo GM-GM
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Oncology and Therapy, Vol 11, Iss 1, Pp 83-96 (2022)
Druh dokumentu: article
ISSN: 2366-1070
2366-1089
DOI: 10.1007/s40487-022-00212-5
Popis: 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.
Databáze: Directory of Open Access Journals
Externí odkaz: