Isatuximab plus pomalidomide and dexamethasone (pom-dex) improves progression-free survival (PFS) and PFS2, compared with pom-dex alone, in patients with relapsed and refractory multiple myeloma (MM), according to data published in The Lancet Oncology.1
These results come from the phase 3 ICARIA-MM trial (ClinicalTrials.gov Identifier: NCT02990338), in which researchers compared isatuximab plus pom-dex with pom-dex alone in patients with MM who had received at least 2 prior lines of therapy, including lenalidomide and a proteasome inhibitor.
The trial included 307 patients — 154 randomly assigned to isatuximab plus pom-dex and 153 to pom-dex alone. In the primary analysis, isatuximab was associated with a significant improvement in PFS.2
In the current analysis, the median duration of treatment was 47.6 weeks in the isatuximab arm and 24.0 weeks in the control arm.1 The proportion of patients who remained on study treatment at the data cutoff was 18% and 8%, respectively.
At a median follow-up of 35.3 months, the median PFS was 11.1 months in the isatuximab arm and 5.9 months in the control arm (hazard ratio [HR], 0.60; 95% CI, 0.46-0.78; P <.0001).
The median overall survival was 24.6 months in the isatuximab arm and 17.7 months in the control arm (HR, 0.76; 95% CI, 0.57-1.01; P =.028).
After progression, 60% of patients in the isatuximab arm received subsequent therapy, as did 72% of patients in the control arm. The median time to next treatment was 15.5 months in the isatuximab arm and 8.9 months in the control arm (HR, 0.56; 95% CI 0.42-0.74; P <.0001).
The median PFS2 was 17.5 months in the isatuximab arm and 12.9 months in the control arm (HR, 0.76; 95% CI, 0.58-0.99; P =.020).
“This study provides the first evidence, to our knowledge, of the long-term efficacy of isatuximab in combination with pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma,” the researchers wrote. “Particularly, the addition of isatuximab continues to provide benefit in delaying progression or death even after a first subsequent line of therapy.”
The most common grade 3 or higher treatment-emergent adverse events (in the isatuximab and control arms, respectively) were neutropenia (50% vs 35%), pneumonia (23% vs 21%), and thrombocytopenia (13% vs 12%).
Serious treatment-emergent adverse events occurred in 73% of patients in the isatuximab arm and 60% of those in the control arm.
There were 2 treatment-related deaths in the isatuximab arm (1 due to sepsis and the other due to cerebellar infarction) and 2 in the control arm (1 due to pneumonia and the other due to urinary tract infection).
Disclosures: This research was supported by Sanofi. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
- Richardson PG, Perrot A, San-Miguel J, et al. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): Follow-up analysis of a randomised, phase 3 study. Lancet Oncol. Published online February 10, 2022. doi:10.1016/S1470-2045(22)00019-5
- Attal M, Richardson PG, Rajkumar SV, et al. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): A randomised, multicentre, open-label, phase 3 study. Lancet. 2019;394(10214):2096-2107. doi:10.1016/S0140-6736(19)32556-5