Haematologica (Apr 2023)

Real-world study of the efficacy and safety of belantamab mafodotin (GSK2857916) in relapsed or refractory multiple myeloma based on data from the nominative ATU in France: the IFM 2020-04 study

  • Alexis Talbot,
  • Arthur Bobin,
  • Léa Tabone,
  • Jérôme Lambert,
  • Catherine Boccaccio,
  • Cécile Deal,
  • Marie-Odile Petillon,
  • Olivier Allangba,
  • Philippe Agape,
  • Pierre Arnautou,
  • Rakiba Belkhir,
  • Sylvie Cailleres,
  • Driss Chaoui,
  • Marie-Lorraine Chrétien,
  • Olivier Decaux,
  • Samantha Schulmann,
  • Laurent Frenzel,
  • Lauris Gastaud,
  • Antoine Huart,
  • Cyrille Hulin,
  • Lionel Karlin,
  • Kamel Laribi,
  • Ronan Le Calloch,
  • Pascal Lenain,
  • Margaret Macro,
  • Salomon Manier,
  • Lydia Montes,
  • Stéphane Moreau,
  • Philippe Moreau,
  • Véronique Morel,
  • James Norwood,
  • Frédérique Orsini Piocelle,
  • Aurore Perrot,
  • Gian Matteo Pica,
  • Philippe Rey,
  • Anna Schmitt,
  • Anne-Marie Stoppa,
  • Mourad Tiab,
  • Cyrille Touzeau,
  • Valérie Vidal,
  • Marguerite Vignon,
  • Laure Vincent,
  • Zoé Van De Wyngaert,
  • Charles Zarnitsky,
  • Naima Kerbouche,
  • Prani Paka,
  • Xavier Leleu,
  • Bertrand Arnulf,
  • Hervé Avet-Loiseau,
  • IFM: Intergroupe Francophone du Myélome

DOI
https://doi.org/10.3324/haematol.2022.281772
Journal volume & issue
Vol. 108, no. 10

Abstract

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Belantamab mafodotin (BM) is an anti-BCMA antibody-drug conjugate (GSK2857916) that represents an alternative option in multiple myeloma. We sought to assess the efficacy and safety of BM in a real-world setting in patients who benefited from an early access program. We conducted an observational, retrospective, multicenter study. Eligibility criteria were treatment of relapsed or refractory multiple myeloma (RRMM) in monotherapy in adult patients who have received at least three lines of therapy previously, including at least one immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody, and whose disease progressed during the last treatment period. The primary endpoint of the study is to assess the overall survival (OS). Between November 2019 and December 2020, 106 patients were treated with BM; 97 were eligible for the efficacy evaluation and 104 for safety. The median age was 66 (range, 37–82) years. High-risk cytogenetics were identified in 40.9% of patients. Fifty-five (56.7%) patients were triple-class refractory and 11 (11.3%) were penta-class refractory. The median number of prior lines of treatment was five (range, 3–12). The median number of BM cycles administered was three (range, 1–22). The overall response rate at best response was 38.1% (37/97). The median OS was 9.3 months (95% confidence interval [CI]: 5.9-15.3), and median progression-free survival was 3.5 months (95% CI: 1.9-4.7). The median duration of response was 9 months (range, 4.65-10.4). Treatment was delayed for 55 (52.9%) patients including 36.5% for treatment-related toxicity. Ophthalmic adverse events, mainly grade ≤2, were the most common toxicity (48%). The occurrence of keratopathy was 37.5%. Overall, our data are concordant with the results from DREAMM-2 in terms of efficacy and safety on a non-biased population.