@article{Talbot_Bobin_Tabone_Lambert_Boccaccio_Deal_Petillon_Allangba_Agape_Arnautou_Belkhir_Cailleres_Chaoui_Chrétien_Decaux_Schulmann_Frenzel_Gastaud_Huart_Hulin_Karlin_Laribi_Le Calloch_Lenain_Macro_Manier_Montes_Moreau_Moreau_Morel_Norwood_Piocelle_Perrot_Pica_Rey_Schmitt_Stoppa_Tiab_Touzeau_Vidal_Vignon_Vincent_Van De Wyngaert_Zarnitsky_Kerbouche_Paka_Leleu_Arnulf_Avet-Loiseau_du Myélome_2023, place={Pavia, Italy}, title={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}, volume={108}, url={https://haematologica.org/article/view/haematol.2022.281772}, DOI={10.3324/haematol.2022.281772}, abstractNote={<p>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.</p&gt;}, number={10}, journal={Haematologica}, author={Talbot, Alexis and Bobin, Arthur and Tabone, Léa and Lambert, Jérôme and Boccaccio, Catherine and Deal, Cécile and Petillon, Marie-Odile and Allangba, Olivier and Agape, Philippe and Arnautou, Pierre and Belkhir, Rakiba and Cailleres, Sylvie and Chaoui, Driss and Chrétien, Marie-Lorraine and Decaux, Olivier and Schulmann, Samantha and Frenzel, Laurent and Gastaud, Lauris and Huart, Antoine and Hulin, Cyrille and Karlin, Lionel and Laribi, Kamel and Le Calloch, Ronan and Lenain, Pascal and Macro, Margaret and Manier, Salomon and Montes, Lydia and Moreau, Stéphane and Moreau, Philippe and Morel, Véronique and Norwood, James and Piocelle, Frédérique Orsini and Perrot, Aurore and Pica, Gian Matteo and Rey, Philippe and Schmitt, Anna and Stoppa, Anne-Marie and Tiab, Mourad and Touzeau, Cyrille and Vidal, Valérie and Vignon, Marguerite and Vincent, Laure and Van De Wyngaert, Zoé and Zarnitsky, Charles and Kerbouche, Naima and Paka, Prani and Leleu, Xavier and Arnulf, Bertrand and Avet-Loiseau, Hervé and du Myélome, IFM: Intergroupe Francophone}, year={2023}, month={Oct.}, pages={2774-2782} }