The Phase 3 ICARIA-MM (NCT02990338) and IKEMA (NCT03275285) studies demonstrated that isatuximab (Isa) plus pomalidomide (P) and dexamethasone (d; Isa-Pd) or carfilzomib (K) and d (Isa-Kd) improved progression-free survival (PFS) versus Pd or Kd in patients with relapsed and/or refractory multiple myeloma. In this post hoc analysis of patients with soft-tissue plasmacytomas, we evaluated Isa-Pd/Isa-Kd efficacy using central radiology and central laboratory assessments. Given the low incidence of soft-tissue plasmacytomas (7.8 %, ICARIA-MM; 6.3 %, IKEMA), efficacy data were pooled across the two studies. PFS (HR, 0.47; 95 % CI, 0.21-1.08), overall response rate (50.0 % vs 17.7 %), and very good partial response or better rate (26.9 % vs 11.8 %) were improved with Isa-Pd/Isa-Kd versus Pd/Kd, with consistent improvements within individual studies. Patients with soft-tissue plasmacytomas who received Isa-Pd/Isa-Kd had similar median PFS compared with those without soft-tissue plasmacytomas and received Pd/Kd. Safety is reported individually per study. Longer median treatment duration and more Grade ≥ 3 treatment-emergent adverse events occurred in the Isa versus control arms in ICARIA-MM (36.9 vs 8.4 weeks; 85.7 % vs 70.0 %) and IKEMA (41.9 vs 29.9 weeks; 100.0 % vs 57.1 %); however, Isa did not increase the percentage of patients with fatal events or drug discontinuation. Isa-Pd or Isa-Kd is a potential new treatment option and partially overcomes the poor prognosis associated with soft-tissue plasmacytomas in relapsed and/or refractory multiple myeloma.

1st Department of Medicine Department of Hematology 1st Faculty of Medicine Charles University and General Hospital Prague Prague Czech Republic

Department of Hemato Oncology University Hospital Ostrava and Faculty of Medicine University of Ostrava Ostrava Czech Republic

Department of Hematology Ankara University Ankara Turkey

Department of Hematology University of California at San Francisco San Francisco CA USA

Hematology Department Nantes University Hospital Nantes France

Hematology Division Department of Internal Medicine University of Patras Medical School Patras Greece

Jerome Lipper Multiple Myeloma Center Dana Farber Cancer Institute Harvard Medical School Boston MA USA

National Institute for Hematology and Infectious Diseases Department of Hematology and Stem Cell Transplantation South Pest Central Hospital Budapest Hungary

Sanofi Cambridge MA USA

SSD Clinical trial in onco ematologia e myeloma multiplo Division of Hematology AOU Città della salute e della scienza di Torino Torino Italy

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Daratumumab with lenalidomide and dexamethasone in relapsed or refractory multiple myeloma patients - real world evidence analysis

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ClinicalTrials.gov
NCT02990338, NCT03275285