Patients with relapsed/refractory multiple myeloma (RRMM) experience several relapses, and become refractory to successive therapies. In the ICARIA-MM trial (NCT02990338), isatuximab plus pomalidomide-dexamethasone prolonged median progression-free survival (PFS) in patients with RRMM. This subgroup analysis of ICARIA-MM assessed the treatment benefit of isatuximab by prior lines of therapy and refractory status. A total of 307 patients were randomized to isatuximab-pomalidomide-dexamethasone (n = 154) or pomalidomide-dexamethasone (n = 153). Isatuximab (10 mg/kg intravenously) was given weekly in the first 28-day cycle, then every other week. Standard pomalidomide-dexamethasone doses were given. PFS was assessed by prior lines and refractory status. Overall, 102 (66 %) patients receiving isatuximab-pomalidomide-dexamethasone and 101 (66 %) patients receiving pomalidomide-dexamethasone had received 2-3 prior lines; 52 (34 %) and 52 (34 %) had received >3 prior lines, respectively. Median PFS was higher with isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone for patients who received 2-3 prior lines of therapy (12.3 vs. 7.8 months) and >3 prior lines of therapy (9.4 vs. 4.3 months). Median PFS was higher with isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone for patients who were lenalidomide-refractory (11.4 vs. 5.6 months), lenalidomide-refractory at last line (11.6 vs. 5.7 months), refractory to a proteasome inhibitor (PI) (11.4 vs. 5.6 months), and double-refractory (11.2 vs. 4.8 months). Overall response rate (ORR) in patients receiving isatuximab-pomalidomide-dexamethasone versus pomalidomide-dexamethasone was 59.0 % versus 31.4 % in lenalidomide-refractory; 60.2 % versus 32.2 % in PI-refractory; and 58.6 % versus 29.9 % in double-refractory patients. Isatuximab-pomalidomide-dexamethasone improved PFS and ORR regardless of prior lines of therapy or refractory status, consistent with the benefit in the overall population.

Aixial Boulogne Billancourt France

Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino Turin Italy

Centre Hospitalier Lyon Sud Hospices Civils de Lyon Pierre Benite France

Charles University Hospital Hradec Kralove Czech Republic

Department of Hematology University Hospital Tours Tours France

Department of Medical Oncology Dana Farber Cancer Institute Harvard Medical School Boston MA USA

Ege University Medical Faculty Izmir Turkey

Hematology and Oncology University Hospital Brno Brno Czech Republic

Instytut Hematologii i Transfuzjologii Warsaw Poland

S P Botkin Hospital Moscow Russia

Sanofi Cambridge MA USA

Sanofi R and D Vitry sur Seine France

Seoul National University Hospital Seoul South Korea

University of Sherbrooke Sherbrooke QC Canada

Citace poskytuje Crossref.org

Isatuximab plus carfilzomib and dexamethasone in patients with relapsed multiple myeloma based on prior lines of treatment and refractory status: IKEMA subgroup analysis

Zobrazit více v PubMed

ClinicalTrials.gov
NCT02990338