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

belantamab mafodotin multiple myeloma real‐world

Journal

EJHaem
ISSN: 2688-6146
Titre abrégé: EJHaem
Pays: United States
ID NLM: 101761942

Informations de publication

Date de publication:
Jun 2024
Historique:
received: 24 01 2024
revised: 02 04 2024
accepted: 05 04 2024
medline: 19 6 2024
pubmed: 19 6 2024
entrez: 19 6 2024
Statut: epublish

Résumé

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.

Identifiants

pubmed: 38895069
doi: 10.1002/jha2.907
pii: JHA2907
pmc: PMC11182418
doi:

Types de publication

Journal Article

Langues

eng

Pagination

485-493

Informations de copyright

© 2024 The Authors. eJHaem published by British Society for Haematology and John Wiley & Sons Ltd.

Déclaration de conflit d'intérêts

Francesca Fazio ‐ advisory board: GSK; honoraria: Amgen, Takeda, Janssen‐Cilag, GSK, BeiGENE, and Sanofi Maria Teresa Petrucci ‐ honoraria: Janssen‐Cilag, Celgene‐BMS, Amgen, Sanofi, GSK, and Takeda; advisory boards: Janssen‐Cilag, Celgene‐BMS, Amgen, Sanofi, GSK, Takeda, Roche, Oncopeptides, Pfizer, Menarini, and AbbVie; support for attending meetings and/or travel: Janssen‐Cilag, Celgene‐BMS, Amgen, Sanofi, and Takeda. Laura Corvatta ‐ honoraria: BMS, Janssen, and GSK. Alfonso Piciocchi ‐ no conflicts of interest. Roberta Della Pepa ‐ advisory boards: Amgen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Sanofi, and Takeda. Paola Tacchetti ‐ honoraria: Amgen, Bristol‐Myers Squibb/Celgene, Janssen, Takeda, AbbVie, Sanofi, GlaxoSmithKline, and Pfizer. Maurizio Musso ‐ no COI. Renato Zambello ‐ advisory boards: Roche, Janssen, Bristol Meier Squibb, Sanofi, Amgen, and GSK. Angelo Belotti ‐ advisory boards: Amgen, GSK, Janssen, Takeda, and Pfizer. Sara Bringhen ‐ speakers’ bureaus: Amgen, Bristol Myers Squibb, GlaxoSmithKline, Janssen, Sanofi, and AbbVie; advisory boards: Bristol Myers Squibb, Janssen, Takeda, Pfizer, Stemline Therapeutics, and Oncopeptides; consultancy fees: Sanofi. Elisabetta Antonioli ‐ advisory boards: Janssen‐Cilag, Celgene‐BMS, Amgen, Sanofi, GSK, Takeda, and Pfizer; support for attending meetings and/or travel: Janssen‐Cilag and Sanofi. Concetta Conticello ‐ honoraria: Takeda, Amgen, Janssen, GSK, BMS, and Sanofi. Nicola Di Renzo ‐ honoraria: Janssen, Bristol Myers Squibb, Gilead, Jazz, and AbbVie; advisory boards: Janssen, Bristol Myers Squibb, Jazz, and AbbVie. Valerio De Stefano ‐ advisory boards for: AOP Health, Argenx, Bristol Myers Squibb, Glaxo Smith Kline, Grifols, Novartis, SOBI, and Takeda; speaker fees from Abbvie, Alexion, Amgen, Bristol Myers Squibb, Grifols, Leo Pharma, Novartis, Novo Nordisk, Sanofi, and Takeda; research grant from Alexion. Pellegrino Musto ‐ honoraria: Abbvie, Alexion, Amgen, Astellas, Astra‐Zeneca, Bei‐Gene, Bristol‐Myers Squibb/Celgene, Gilead, Glaxo‐Smith‐Kline, Grifols, Incyte, Janssen, Jazz, Novartis, Pfizer, Roche, Sanofi, Sobi, and Takeda. Barbara Gamberi ‐ honoraria: Amgen, Bristol Myers Squibb, Janssen, and Takeda; advisory boards: Amgen, Bristol Myers Squibb, GlaxoSmithKline, Janssen, Sanofi, and Takeda. Daniele Derudas ‐ no conflicts of interest. Mario Boccadoro ‐ honoraria: Sanofi, Celgene, Amgen, Janssen, Novartis, Bristol Myers Squibb, and AbbVie; advisory boards: Janssen and GlaxoSmithKline; research funding: Sanofi, Celgene, Amgen, Janssen, Novartis, Bristol Myers Squibb, and Mundipharma. Massimo Offidani ‐ honoraria and advisory boards: Amgen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Sanofi, and Takeda. Sonia Morè ‐ honoraria: BMS, Janssen, and GSK.

Auteurs

Francesca Fazio (F)

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

Maria Teresa Petrucci (MT)

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

Laura Corvatta (L)

Unità Operativa Complessa di Medicina Ospedale Profili Fabriano Italy.

Alfonso Piciocchi (A)

GIMEMA Foundation Rome Italy.

Roberta Della Pepa (RD)

Hematology Unit, Department of Clinical Medicine and Surgery University of Naples "Federico II" Naples Italy.

Paola Tacchetti (P)

IRCCS Azienda Ospedaliero-Universitaria di Bologna-Istituto di Ematologia "Seràgnoli" Bologna Italy.

Maurizio Musso (M)

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

Renato Zambello (R)

Hematology Unit Department of Medicine University of Padova Padua Italy.

Angelo Belotti (A)

Department of Hematology ASST Spedali Civili di Brescia Brescia Italy.

Sara Bringhen (S)

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 (E)

Haematology Unit Careggi University Hospital Florence Italy.

Concetta Conticello (C)

Division of Haematology and BMT A.O.U. 'Policlinico-San Marco' Catania Italy.

Nicola Di Renzo (ND)

Hematology and Stem Cell Transplant Unit "Vito Fazzi" Hospital Lecce Italy.

Valerio De Stefano (V)

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

Pellegrino Musto (P)

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 (B)

Hematology Unit Azienda USL- IRCCS di Reggio Emilia Reggio Emilia Italy.

Daniele Derudas (D)

SC di Ematologia e CTMO - Oncologico Oncologico di Riferimento Regionale "A. Businco" - ARNAS "G. Brotzu" Cagliari Italy.

Mario Boccadoro (M)

European Myeloma Network Turin Italy.

Massimo Offidani (M)

Department of Hematology Azienda Ospedaliero Universitaria delle Marche Ancona Italy.

Sonia Morè (S)

Department of Hematology Azienda Ospedaliero Universitaria delle Marche Ancona Italy.

Classifications MeSH