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Vol. 42. Issue S2.
Pages 263-264 (November 2020)
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Vol. 42. Issue S2.
Pages 263-264 (November 2020)
Open Access
M.E.Z. Capraa, M. Beksacb, P.G. Richardsonc, A. Unald, P. Corradinie, S. Delimpasif, Z. Gulbasg, G. Mikalah, A. Neyloni, A. Symeonidisj, S. Bringhenk, P. Moreaul, H.V. Veldem, F. Campanam, S.L. Guennecn, I. Spickao
a Hospital Mãe de Deus, Porto Alegre, RS, Brazil
b Department of Hematology, Ankara University, Ankara, Turkey
c Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, United States
d Department of Hematology, Erciyes University Medical School, Kayseri, Turkey
e Division of Hematology, Istituto Nazionale dei Tumori, University of Milano, Milan, Italy
f Department of Haematology, General Hospital of Athens, Athens, Greece
g Anadolu Medical Center, Kocaeli, Turkey
h Department of Hematology and Stem Cell Transplantation, South Pest Central Hospital, Budapest, Hungary
i Department of Haematology, Dunedin Hospital, Dunedin, New Zealand
j Hematology Division, Department of Internal Medicine, University of Patras Medical School, Patras, Greece
k Myeloma Unit, Division of Hematology, University of Torino, Torino, Italy
l Hematology Department, Nantes University Hospital, Nantes, France
m Sanofi R&D, Cambridge, United States
n Sanofi R&D, Vitry-Sur-Seine, France
o 1st Department of Medicine – Department of Hematology First Faculty of Medicine Charles University and General Hospital in Prague, Prague, Czech Republic
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Aim: To assess the efficacy and safety of treatment with Isatuximab-Pomalidomide plus dexamethasone (Isa-Pd) compared with Pd in patients with relapsed/refractory multiple myeloma (RRMM) and pre-existing plasmacytomas. Methods: 307 RRMM patients were randomized to two study arms (NCT02990338): Isa-Pd (n = 154) or Pd (n = 153). Isa was administered intravenously at 10 mg/kg weekly for 4 weeks, and every other week thereafter. If soft-tissue plasmacytomas were present at study entry, a computed tomography (CT) scan or magnetic resonance imaging (MRI) was carried out at baseline and repeated every 12 ± 1 weeks, and when clinically indicated. Imaging results were submitted to central radiology review as part of the independent review committee assessment. The primary objective was to assess the impact of Isa-Pd on the progression free survival (PFS) compared with Pd. Safety information including treatment-emergent adverse events (TEAEs) was assessed according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.03. Results: At study entry, soft-tissue plasmacytomas were present in 24 (7.8%) patients (14 [9.1%] in the Isa-Pd and 10 [6.5%] patients in the Pd arm). Baseline characteristics of patients with plasmacytomas included: median age, 61 (range 36, 82) years in the Isa-Pd arm vs. 64 (42, 71) years in the Pd arm; median (range) number of prior regimens before study entry, 3.5 (2, 13) in the Isa-Pd arm vs. 5.5 (2, 6) in the Pd arm; International Staging System, Stage I 50.0%, Stage II, 21.4% and Stage III, 28.6% in the Isa-Pd arm vs Stage I 10.0%, Stage II, 50.0% and Stage III, 40.0% in the Pd arm; high-risk cytogenetics, 21.4% in the Isa-Pd vs. 10% in the Pd arm. PFS was improved by adding Isa to Pd: hazard ratio: 0.22, 95% confidence intervals (CI): 0.07, 0.69. Median PFS was 4.57 (95% CI: 2.40, not calculable [NC]) months in the Isa-Pd arm vs. 1.56 (95% CI: 0.95, 4.47) months in the Pd arm. The probability of PFS at 12 months was 0.31 (95% CI: 0.10, 0.56) in the Isa-Pd arm vs. 0.00 (95% CI: NC, NC) in the Pd arm. The overall response rate (ORR) also improved with 50% (7/14) and 10% (1/10) responders in the Isa-Pd and Pd arms, respectively. Very good partial response (VGPR) occurred in 21.4% (3/14) of patients in the Isa-Pd arm and 10% (1/10) of patients in the Pd arm. Two patients with VGPR in the Isa-Pd arm who presented with plasmacytomas at baseline showed complete remission at cycle 3 and significant reduction at cycle 4 of the extramedullary lesions, respectively, vs 0 in the Pd arm. Grade ≥3 TEAE occurred in 12/14 (85.7%) patients in Isa-Pd arm and 7/10 (70.0%) patients in the Pd arm. Infusion reactions (IRs) of any Grade occurred in 42.9% of Isa-Pd patients, but there were no Grade ≥3 IRs. Conclusions: In patients with RRMM and plasmacytomas, Isa-Pd treatment significantly prolonged PFS and improved ORR compared with Pd alone, with a manageable safety profile. The trend in efficacy and safety of plasmacytoma patients treated with Isa-Pd are consistent with the ICARIA-MM overall population and other study subgroups. Data first presented at EHA 2020, 11th-21st June 2020. Study sponsored by Sanofi.

Hematology, Transfusion and Cell Therapy

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