Belantamab mafodotin in triple‐refractory multiple myeloma patients: A retro‐prospective observational study in Italy

Author:

Fazio Francesca1ORCID,Petrucci Maria Teresa1,Corvatta Laura2,Piciocchi Alfonso3,Pepa Roberta Della4,Tacchetti Paola5,Musso Maurizio6,Zambello Renato7ORCID,Belotti Angelo8,Bringhen Sara9,Antonioli Elisabetta10,Conticello Concetta11,Renzo Nicola Di12,De Stefano Valerio13ORCID,Musto Pellegrino14,Gamberi Barbara15ORCID,Derudas Daniele16,Boccadoro Mario17,Offidani Massimo18ORCID,Morè Sonia18

Affiliation:

1. Hematology Unit, Department of Translational and Precision Medicine Azienda Ospedaliera Policlinico Umberto I Sapienza University of Rome Rome Italy

2. Unità Operativa Complessa di Medicina Ospedale Profili Fabriano Italy

3. GIMEMA Foundation Rome Italy

4. Hematology Unit, Department of Clinical Medicine and Surgery University of Naples “Federico II” Naples Italy

5. IRCCS Azienda Ospedaliero‐Universitaria di Bologna‐Istituto di Ematologia “Seràgnoli” Bologna Italy

6. Oncoematology and BMT Unit, Oncology Department Ospedale La maddalena Palermo Palermo Italy

7. Hematology Unit Department of Medicine University of Padova Padua Italy

8. Department of Hematology ASST Spedali Civili di Brescia Brescia Italy

9. SSD Clinical Trial in Oncoematologia e Mieloma Multiplo Department of Oncology Azienda Ospedaliero‐Universitaria Città della Salute e della Scienza di Torino Turin Italy

10. Haematology Unit Careggi University Hospital Florence Italy

11. Division of Haematology and BMT A.O.U. ‘Policlinico‐San Marco’ Catania Italy

12. Hematology and Stem Cell Transplant Unit “Vito Fazzi” Hospital Lecce Italy

13. Section of Hematology Department of Radiological and Hematological Sciences Catholic University Fondazione Policlinico A Gemelli IRCCS Rome Italy

14. Department of Precision and Regenerative Medicine and Ionian Area “Aldo Moro” University School of Medicine, and Unit of Hematology and Stem Cell Transplantation AOUC Policlinico Bari Italy

15. Hematology Unit Azienda USL‐ IRCCS di Reggio Emilia Reggio Emilia Italy

16. SC di Ematologia e CTMO ‐ Oncologico Oncologico di Riferimento Regionale “A. Businco” ‐ ARNAS “G. Brotzu” Cagliari Italy

17. European Myeloma Network Turin Italy

18. Department of Hematology Azienda Ospedaliero Universitaria delle Marche Ancona Italy

Abstract

AbstractBelantamab mafodotin is the first‐in‐class antibody‐drug conjugates targeting B‐cell maturation antigen to have demonstrated effectiveness in triple‐class refractory multiple myeloma (TCR‐MM) patients. We performed a retrospective study including 78 TCR patients, with at least four prior lines of therapy (LOTs), who received belantamab mafodotin within named patient program and expanded access program in Italy between 2020 and 2022. Median age was 65 years (range 42–86 years), ECOG performance status was ≥1 in 45% of patients. Overall, a clinical benefit was obtained in 36 out of 74 evaluable patients (49%), with 43%, 28%, and 13.5% achieving at least partial response, very good partial response, and complete response, respectively. After a median follow‐up of 12 months (range 6–21 months), median duration of response, progression‐free survival (PFS), and overall survival (OS) were 14, 5.5, and 12 months, respectively. Age >70 years, good performance status and response were associated with longer PFS and OS. Keratopathy occurred in 58% of patients (G3 2.5%), corneal symptoms in 32% (G3 1.2%) and a reduction in visual acuity in 14%. Grade 3 thrombocytopenia occurred in 9% of patients. Only 3% of patients discontinued belantamab mafodotin because of side effects. This real‐life study demonstrated significant and durable responses of belantamab in TCR‐MM patients with four prior LOTs, otherwise ineligible for novel immunotherapies.

Publisher

Wiley

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