1. Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma according to prior lines of treatment and refractory status: ICARIA-MM subgroup analysis
- Author
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Lotfi Benboubker, Paul G. Richardson, Krzysztof Warzocha, Lionel Karlin, Vladimir Maisnar, Vladimir Vorobyev, Michel Pavic, Filiz Vural, Solenn Le Guennec, Ludek Pour, Sara Bringhen, Youngil Koh, Fatima Menas, Helgi van de Velde, and Frank Campana
- Subjects
Male ,Cancer Research ,medicine.medical_specialty ,Population ,Subgroup analysis ,Antibodies, Monoclonal, Humanized ,Gastroenterology ,Dexamethasone ,Disease-Free Survival ,Relapsed ,03 medical and health sciences ,0302 clinical medicine ,Refractory ,Multiple myeloma ,Internal medicine ,Daratumumab ,Antineoplastic Combined Chemotherapy Protocols ,Humans ,Medicine ,Prospective Studies ,education ,Aged ,Aged, 80 and over ,Isatuximab ,education.field_of_study ,Hematology ,business.industry ,anti-CD38 monoclonal antibody ,Middle Aged ,medicine.disease ,Pomalidomide ,Criteria ,Thalidomide ,Survival Rate ,Oncology ,030220 oncology & carcinogenesis ,Female ,Prior lines ,business ,Sar650984 ,030215 immunology ,medicine.drug - Abstract
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. © 2021 The Authors, Amgen Bristol-Myers Squibb, BMS Pfizer Roche Sanofi Celgene Takeda Pharmaceutical Company, TPC Janssen Pharmaceuticals, SB reports honoraria from Amgen, Bristol-Myers Squibb, Celgene, and Janssen; and reports a consultancy/advisory role for Celgene, Janssen, Karyopharm, and Takeda. VV reports a consultancy/advisory role for Astellas, Biocad, Bristol-Myers Squibb, Janssen, Roche, Sanofi, and Takeda. VM reports a consultancy/advisory role for Amgen, Bristol-Myers Squibb, Celgene, Janssen, and Takeda. LK reports honoraria from Amgen, Celgene, Janssen, and Takeda; a consultancy/advisory role for Amgen, Celgene, Janssen, and Takeda; and travel support from Amgen and Janssen. MP reports honoraria from Celgene, Pfizer, and Takeda; consultancy/advisory role for Amgen, Celgene, Janssen, Roche, and Takeda; and research funding from Amgen, Celgene, Janssen, Pfizer, Roche, and Takeda. PGR reports a consultancy/advisory role for Amgen, Janssen, Karyopharm, Oncopeptides, Sanofi, and Takeda; and research funding from Bristol-Myers Squibb, Celgene, Oncopeptides, and Takeda. LP, FV, KW, LB, and YK have no disclosures. FC, SLG, FM, and HvdV are employees of Sanofi., The ICARIA-MM study was sponsored by Sanofi . The authors thank the participating patients and their families, and the study centers and investigators for their contributions to the study. Medical writing support was provided by Stephanie Brillhart, Julian Ball, and Smitha Reddy of Elevate Medical Affairs E (Fairfield, CT, USA), and funded by Sanofi (Cambridge, MA, USA).
- Published
- 2021