Oncology and Therapy (Dec 2022)

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

  • 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

DOI
https://doi.org/10.1007/s40487-022-00212-5
Journal volume & issue
Vol. 11, no. 1
pp. 83 – 96

Abstract

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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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