Among patients with relapsed/refractory multiple myeloma (MM), treatment with isatuximab plus pomalidomide and dexamethasone (IsaPd), compared with pomalidomide and dexamethasone alone (Pd), improved health-related quality of life, even in heavily pre-treated patients and those with renal impairment, according to the phase III ICARIA study, which was presented at the 2020 ASH Annual Meeting.
Researchers conducted a post-hoc analysis of the randomized, open-label, phase III ICARIA clinical trial. During the study, patients completed electronic versions of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the EORTC myeloma-specific module on day one of each 28-day treatment cycle until disease progression or unacceptable toxicity.
Among heavily pre-treated patients (defined as having received three or more prior lines of therapy), 47 received IsaPd and 46 received Pd. In this cohort, Global Health Status/quality of life, C30 pain, and myeloma-specific module disease symptom scores trended toward improvement in the IsaPd group. There also appeared to be a clinically meaningful improvement in C30 pain in treatment cycles seven to 10, 12 to 13, and 15 to 16 for heavily pre-treated patients receiving IsaPd; these improvements were only seen after cycle 15 of Pd. C30 physical and role function were better maintained with IsaPd versus Pd. Quality of life scores were similar between the two treatment arms in moderately pre-treated patients (defined as having received two to three prior therapies).
In patients with baseline renal impairment, 51 were treated with IsaPd and 42 with Pd. Again, in this population, Global Health Status/quality of life, C30 pain, and myeloma-specific module disease symptom scores trended toward improvement with IsaPd. Clinically meaningful improvements in C30 pain were also observed in those receiving IsaPd at cycles 10, 13, and 15 to 16; these improvements were only seen at cycles 16 to 17 with Pd. C30 physical and role function were better maintained in those receiving IsaPd. C30 fatigue was better maintained with IsaPd, whereas in the Pd cohort, C30 fatigue worsened at treatment cycles five, eight, and nine. Health-related quality of life outcomes were comparable between the treatment arms in patients without renal impairment.
“Isatuximab provides an important new treatment option in relapsed/refractory MM, including difficult-to-treat subgroups,” the researchers concluded.
Dimopoulos MA, Campana F, Bury D, et al. Health-Related Quality of Life in Heavily Pre-Treated and Renally Impaired Patients with Relapsed/Refractory Multiple Myeloma Receiving Isatuximab Plus Pomalidomide and Dexamethasone: Icaria-MM Study. Abstract 3438. Presented at the 62nd American Society of Hematology Annual Meeting & Exposition, Dec. 2-11, 2020.