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Vol. 43. Núm. S3.
Páginas S18 (Novembro 2021)
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Vol. 43. Núm. S3.
Páginas S18 (Novembro 2021)
OP 07
Open Access
ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AND SOFT-TISSUE PLASMACYTOMAS: IKEMA SUBGROUP ANALYSIS
Visitas
966
Mehmut TURGUT1, Roman HAJEK2, Tomas JELÍNEK3, Philippe MOREAU4, Thomas MARTIN5, Ludek POUR6, Gabor MIKALA7, Argiris SYMEONIDIS8, Sara BRINGHEN9, Andreea RAWLINGS10, Marie Laure RISSE10, Helgi VAN DE VELDE10, Ivan SPICKA11
1 Department of Hematology, Ondokuz Mayıs University
2 Department of Hemato-Oncology, University Hospital Ostrava and University of Ostrava
3 Department of Haemato-Oncology, University Hospital Ostrava and Faculty of Medicine, University of Ostrava
4 Department of Hematology, University Hospital Hôtel-Dieu
5 Department of Hematology, University of California at San Francisco
6 Department of Internal Medicine, Hematology and Oncology, University Hospital Brno
7 National Institute for Hematology and Infectious Diseases, Department of Hematology and Stem Cell Transplantation, South Pest Central Hospital
8 Hematology Division, Department of Internal Medicine, University of Patras Medical School
9 Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
10 Sanofi Research & Development
11 Faculty of Medicine, Department of Hematology, Charles University and General Hospital in Prague
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Vol. 43. Núm S3
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Objective

Phase 3 IKEMA study (NCT03275285) showed significant improvement in PFS with Isatuximab (Isa) + carfilzomib (K) and dexamethasone (d) vs Kd in patients (pts) with relapsed multiple myeloma (MM) (HR: 0.531; 99% CI: 0.32–0.89; P=0.0007), leading to approval of Isa-Kd in US for adults with MM with 1–3 prior lines and in EU for those with ≥1 prior therapy. This post-hoc analysis evaluated efficacy and safety of Isa-Kd vs Kd in relapsed MM pts with pre-existing soft-tissue plasmacytomas (STP).

Methodology

Pts (N=302) were randomized (3:2) to Isa-Kd (n=179; 12 had STP) or Kd (n=123; 7 had STP). Doses: Isa: 10 mg/kg IV QW for 4 weeks, then Q2W; K 20 mg/m² days 1–2, then 56 mg/m² twice-weekly 3 of 4 weeks; d: 20 mg twice-weekly. Independent review committee assessed response based on central radiology review and central lab M-protein using International Myeloma Working Group criteria. Median (range) duration of exposure in STP pts (Isa-Kd vs Kd) was 41.9 (2–87) vs 29.9 (4–83) weeks.

Results

In STP sub-group, PFS (95% CI) improved in Isa-Kd vs Kd: HR 0.574 (0.125–2.640); median PFS was Isa-Kd: 18.76 months (4.435–not calculable [NC]) vs Kd: NC (0.986–NC). Response rates improved in Isa-Kd vs Kd: overall (50.0% vs 28.6%), ≥VGPR (33.3% vs 14.3%), CR (25.0% vs 0%, all with MRD negativity). TEAE rates (n [%]; Isa-Kd vs Kd) were: Grade ≥3: 12 (100%) vs 4 (57.1%); Grade 5: 2 (16.7%) vs 1 (14.3%); serious: 9 (75.0%) vs 4 (57.1%); discontinuation: 0 (0%) vs 1 (14.3%).

Conclusion

Baseline characteristics in STP subgroup were similar to overall ITT population, except ISS stages II, III, and renal function impairment, which were more prevalent in STP subgroup vs ITT. Isa-Kd vs Kd improved PFS and depth of response in pts with relapsed MM and STP, with manageable safety profile, consistent with the benefit observed in IKEMA overall population. Isa-Kd is a new treatment option for pts with relapsed MM and STP.

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Hematology, Transfusion and Cell Therapy
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