The first interim analysis of the real-world IONA-MM registry study suggests that the safety profile of isatuximab plus pomalidomide and dexamethasone (Isa-Pd) or carfilzomib and dexamethasone (Isa-Kd) was similar to that observed in phase 3 clinical trials among patients with relapsed/refractory multiple myeloma (RRMM), according a poster presented at Annual Meeting of the Society of Hematologic Oncology (SOHO).
Isa-Pd and Isa-Kd were shown to improve outcomes among patients with RRMM; however, data of real-world outcomes has been limited. The aim of the IONA-MM registry is to evaluate the efficacy, safety, and quality of life impact with isatuximab treatment for patients with RRMM.
The noninterventional, observational IONA-MM registry is enrolling patients with RRMM treated with isatuximab-based regimens outside of a clinical trial. Patients are enrolled prospectively or retrospectively if treated with isatuximab within 3 months of enrollment. These data are of 81 patients treated with Isa-Pd and 26 treated with Isa-Kd.
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Patient demographics and baseline characteristics were similar between IONA-MM and the ICARIA-MM and IKEMA phase 3 trials. The median age of patients in IONA-MM was 71, 12.5% had high cytogenetic risk, and the majority had an Eastern Cooperative Oncology Group performance status of 0 or 1. The median number of prior lines of therapy was 3.
There were 44.4% and 38.5% of patients registered in IONA-MM treated with Isa-Pd or Isa-Kd, respectively, who developed grade 3-4 treatment-emergent adverse events (TEAE). The rate of serious TEAEs was 25.9% and 30.8% with Isa-Pd and Isa-Kd, respectively. In contrast, the rates of grade 3-4 TEAEs was 88.8% in ICARIA-MM and 75.7% in IKEMA, and serious TEAEs developed among 73% and 59.3%, respectively.
Treatment discontinuation was higher in the IONA-MM registry than the phase 3 trials, with 7.4% and 11.5% of patients in treated with Isa-Pd and Isa-Kd, respectively, in IONA-MM ending isatuximab therapy compared with 2.6% and 0.6% in the ICARIA-MM and IKEMA trials, respectively.
The most common grade 3 or higher TEAEs in IONA-MM was neutropenia among patients treated with Isa-Pd, and neutropenia, pneumonia, and acute liver injury among patients treated with Isa-Kd.
The authors concluded that “both Isa-Pd and Isa-Kd had an expected safety profile with a low rate of discontinuation due to an adverse event in routine clinical practice.” They added that response to isatuximab will be reported in the future and enrollment is ongoing.
Disclosures: This study was supported by Sanofi. Please see the original reference for a full list of disclosures.
Reference
Manasanch EE, Beksac M, Cavo M, et al. Real-world experience with isatuximab in patients with relapsed and/or refractory multiple myeloma (RRMM): IONA-MM first interim analysis. Presented at: Annual Meeting of the Society of Hematologic Oncology (SOHO); September 28-October 1, 2022. Abstract MM-086.
