Belantamab mafodotin in triple‐refractory multiple myeloma patients: A retro‐prospective observational study in Italy
Francesca Fazio,
Maria Teresa Petrucci,
Laura Corvatta,
Alfonso Piciocchi,
Roberta Della Pepa,
Paola Tacchetti,
Maurizio Musso,
Renato Zambello,
Angelo Belotti,
Sara Bringhen,
Elisabetta Antonioli,
Concetta Conticello,
Nicola Di Renzo,
Valerio De Stefano,
Pellegrino Musto,
Barbara Gamberi,
Daniele Derudas,
Mario Boccadoro,
Massimo Offidani,
Sonia Morè
Affiliations
Francesca Fazio
Hematology Unit, Department of Translational and Precision Medicine Azienda Ospedaliera Policlinico Umberto I Sapienza University of Rome Rome Italy
Maria Teresa Petrucci
Hematology Unit, Department of Translational and Precision Medicine Azienda Ospedaliera Policlinico Umberto I Sapienza University of Rome Rome Italy
Laura Corvatta
Unità Operativa Complessa di Medicina Ospedale Profili Fabriano Italy
Alfonso Piciocchi
GIMEMA Foundation Rome Italy
Roberta Della Pepa
Hematology Unit, Department of Clinical Medicine and Surgery University of Naples “Federico II” Naples Italy
Paola Tacchetti
IRCCS Azienda Ospedaliero‐Universitaria di Bologna‐Istituto di Ematologia “Seràgnoli” Bologna Italy
Maurizio Musso
Oncoematology and BMT Unit, Oncology Department Ospedale La maddalena Palermo Palermo Italy
Renato Zambello
Hematology Unit Department of Medicine University of Padova Padua Italy
Angelo Belotti
Department of Hematology ASST Spedali Civili di Brescia Brescia Italy
Sara Bringhen
SSD Clinical Trial in Oncoematologia e Mieloma Multiplo Department of Oncology Azienda Ospedaliero‐Universitaria Città della Salute e della Scienza di Torino Turin Italy
Elisabetta Antonioli
Haematology Unit Careggi University Hospital Florence Italy
Concetta Conticello
Division of Haematology and BMT A.O.U. ‘Policlinico‐San Marco’ Catania Italy
Nicola Di Renzo
Hematology and Stem Cell Transplant Unit “Vito Fazzi” Hospital Lecce Italy
Valerio De Stefano
Section of Hematology Department of Radiological and Hematological Sciences Catholic University Fondazione Policlinico A Gemelli IRCCS Rome Italy
Pellegrino Musto
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
Barbara Gamberi
Hematology Unit Azienda USL‐ IRCCS di Reggio Emilia Reggio Emilia Italy
Daniele Derudas
SC di Ematologia e CTMO ‐ Oncologico Oncologico di Riferimento Regionale “A. Businco” ‐ ARNAS “G. Brotzu” Cagliari Italy
Mario Boccadoro
European Myeloma Network Turin Italy
Massimo Offidani
Department of Hematology Azienda Ospedaliero Universitaria delle Marche Ancona Italy
Sonia Morè
Department of Hematology Azienda Ospedaliero Universitaria delle Marche Ancona Italy
Abstract Belantamab 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.