Isatuximab-pomalidomide-dexamethasone <i>versus</i> pomalidomide-dexamethasone in patients with relapsed and refractory multiple myeloma: final overall survival analysis
Paul G. Richardson,
Aurore Perrot,
Jesus San Miguel,
Meral Beksac,
Ivan Spicka,
Xavier Leleu,
Fredrik Schjesvold,
Philippe Moreau,
Meletios A. Dimopoulos,
Shang-Yi Huang,
Jiri Minarik,
Michele Cavo,
H. Miles Prince,
Sandrine Macé,
Rick Zhang,
Franck Dubin,
Mony Chenda Morisse,
Kenneth C. Anderson
Affiliations
Paul G. Richardson
Jerome Lipper Multiple Myeloma Center, Department of Medical Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA
Aurore Perrot
CHU de Toulouse, IUCT-O, Université de Toulouse, UPS, Service d’Hématologie, Toulouse
Jesus San Miguel
Clínica Universidad de Navarra, Navarra, CCUN, CIMA, IDISNA, CIBER-ONC, Pamplona
Meral Beksac
Department of Hematology, Ankara University, Ankara, Turkey
Ivan Spicka
General Faculty Hospital, Prague, Czech Republic; First Faculty of Medicine, Charles University, Prague, Czech Republic
Xavier Leleu
Service d’Hématologie et Thérapie Cellulaire, CHU and CIC Inserm 1402, Poitiers Cedex
Fredrik Schjesvold
Oslo Myeloma Center, Department of Haematology, Oslo University Hospital, Oslo, Norway; KG Jebsen Center for B Cell Malignancies, University of Oslo, Oslo, Norway
Philippe Moreau
Hematology Department, CHU Nantes, Nantes
Meletios A. Dimopoulos
Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens School of Medicine, Athens, Greece
Shang-Yi Huang
Department of Hematology, National Taiwan University Hospital, Taipei, Taiwan
Jiri Minarik
Department of Hemato-Oncology, Faculty of Medicine and Dentistry, Palacky University and University Hospital Olomouc, Olomouc, Czech Republic
Michele Cavo
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Seràgnoli Institute of Hematology, and the Department of Medical and Surgical Sciences, Bologna University School of Medicine, Bologna, Italy
H. Miles Prince
Immunology and Molecular Oncology, Epworth Healthcare, University of Melbourne, Melbourne, VIC, Australia
Sandrine Macé
Sanofi, Vitry-sur-Seine
Rick Zhang
Sanofi, Cambridge, MA
Franck Dubin
Sanofi, Vitry-sur-Seine
Mony Chenda Morisse
Sanofi, Cambridge, MA
Kenneth C. Anderson
Jerome Lipper Multiple Myeloma Center, Department of Medical Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA
The primary and pre-specified updated analyses of ICARIA-MM (NCT02990338) demonstrated improved progression-free survival 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 3 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 (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 (95% confidence interval) was 24.6 months (20.3–31.3 months) with Isa-Pd and 17.7 months (14.4–26.2 months) 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 vs. 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 overall survival in patients with relapsed/refractory multiple myeloma.
