Page 225 - Haematologica Vol. 109 - July 2024

ARTICLE - Plasma Cell Disorders
Isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone in patients with relapsed and refractory multiple myeloma: final overall survival analysis
Paul G. Richardson,1 Aurore Perrot,2 Jesus San Miguel,3 Meral Beksac,4 Ivan Spicka,5,6 Xavier Leleu,7 Fredrik Schjesvold,8,9 Philippe Moreau,10 Meletios A. Dimopoulos,11 Shang-Yi Huang,12 Jiri Minarik,13 Michele Cavo,14 H. Miles Prince,15 Sandrine Macé,16 Rick Zhang,17 Franck Dubin,16 Mony Chenda Morisse17 and Kenneth C. Anderson1
1Jerome Lipper Multiple Myeloma Center, Department of Medical Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA, USA; 2CHU de Toulouse, IUCT-O, Université de Toulouse, UPS, Service d’Hématologie, Toulouse, France; 3Clínica Universidad de Navarra, Navarra, CCUN, CIMA, IDISNA, CIBER-ONC, Pamplona, Spain; 4Department of Hematology, Ankara University, Ankara, Turkey; 5General Faculty Hospital, Prague, Czech Republic; 6First Faculty of Medicine, Charles University, Prague, Czech Republic; 7Service d’Hématologie et Thérapie Cellulaire, CHU and CIC INSERM 1402, Poitiers Cedex, France; 8Oslo Myeloma Center, Department of Hematology, Oslo University Hospital, Oslo, Norway; 9KG Jebsen Center for B Cell Malignancies, University of Oslo, Oslo, Norway; 10Hematology Department, CHU Nantes, Nantes, France; 11Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens School of Medicine, Athens, Greece; 12Department of Hematology, National Taiwan University Hospital, Taipei, Taiwan; 13Department of Hemato-Oncology, Faculty of Medicine and Dentistry, Palacky University and University Hospital Olomouc, Olomouc, Czech Republic; 14IRCCS Azienda Ospedaliero-Universitaria di Bologna, Seràgnoli Institute of Hematology, and the Department of Medical and Surgical Sciences, Bologna University School of Medicine, Bologna, Italy; 15Immunology and Molecular Oncology, Epworth Healthcare, University of Melbourne, Melbourne, Victoria, Australia; 16Sanofi, Vitry-sur-Seine, France and 17Sanofi, Cambridge, MA, USA
Abstract
The primary and prespecified updated analyses of ICARIA-MM (clinicaltrial gov. Identifier: NCT02990338) demonstrated im- proved progression-free survival (PFS) and a benefit in overall survival (OS) was reported with the addition of isatuximab, an anti-CD38 monoclonal antibody, to pomalidomide-dexamethasone (Pd) in patients with relapsed/refractory multiple myeloma. Here, we report the final OS analysis. This multicenter, randomized, open-label, phase III study included patients who had received and failed ≥2 previous therapies, including lenalidomide and a proteasome inhibitor. Between January 10, 2017, and February 2, 2018, 307 patients were randomized (1:1) to isatuximab-pomalidomide-dexamethasone (Isa-Pd; N=154) or Pd (N=153), stratified based on age (<75 vs. ≥75 years) and number of previous lines of therapy (2-3 vs. >3). At data cutoff for the final OS analysis after 220 OS events (January 27, 2022), median follow-up duration was 52.4 months. Median OS was 24.6 months (95% confidence interval [CI]: 20.3-31.3) with Isa-Pd and 17.7 months (95% CI: 14.4- 26.2) with Pd (hazard ratio=0.78; 95% CI: 0.59-1.02; 1-sided P=0.0319). Despite subsequent daratumumab use in the Pd group and its potential benefit on PFS in the first subsequent therapy line, median PFS2 was significantly longer with Isa-Pd versus Pd (17.5 vs. 12.9 months; log-rank 1-sided P=0.0091). In this analysis, Isa-Pd continued to be efficacious and well tolerated after follow-up of approximately 52 months, contributing to a clinically meaningful, 6.9-month improvement in median OS in patients with relapsed/refractory multiple myeloma.
Haematologica | 109 July 2024
Correspondence: P. Richardson paul_richardson@dfci.harvard.edu
Received: Accepted: Early view:
October 4, 2023. January 24, 2024. February 1, 2024.
https://doi.org/10.3324/haematol.2023.284325
Published under a CC BY license
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