Real-World Outcomes of Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results of a Spanish Expanded Access Program (EAP)
Adrían Alegre, Gonzalo Benzo, Rafael Alonso, Joaquín Martínez‐López, Ana Jiménez Ubieto, Clara Cuéllar, Elham Askari, Elena Prieto, Concepción Aláez, Beatriz Aguado, Alberto Velasco, Isabel Krsnik, Ana Bocanegra, Laura Llorente, Cristina Muñoz‐Linares, Ana I. Morales, Eugenio Giménez, Rebeca Iglesias, Carmen Martínez‐Chamorro, Aránzazu Alonso, Carmen Jiménez-Montes, María Jesús Blanchard, Grupo GM-GM, Adrían Alegre, Gonzalo Benzo, Rafael Alonso, Joaquín Martínez‐López, Ana Jiménez Ubieto, Clara Cuéllar, Elham Askari, Elena Prieto, Concepción Aláez, Beatriz Aguado, Alberto Velasco, Isabel Krsnik, Ana Bocanegra, Laura Llorente, Cristina Muñoz‐Linares, Ana I. Morales, Eugenio Giménez, Rebeca Iglesias, Carmen Martínez-Chamorro, Aránzazu Alonso, Carmen Jiménez-Montes, María J. Blanchard
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.