Adding isatuximab to pomalidomide and low-dose dexamethasone (pom-dex) may provide long-term benefits in patients with relapsed or refractory multiple myeloma (MM), according to research presented at the European Hematology Association (EHA) 2021 Virtual Congress.1
Previous results from the phase 3 ICARIA-MM trial (ClinicalTrials.gov Identifier: NCT02990338) showed that adding isatuximab to pom-dex could improve progression-free survival (PFS).2
At EHA 2021, Aurore Perrot, MD, PhD, of Toulouse University Hospital in France, presented updated results from ICARIA-MM. The data showed continued improvement in PFS with isatuximab, as well as prolonged time to next treatment and improvement in PFS2, defined as time from randomization to disease progression or death on first subsequent therapy.
The trial included 307 patients who were randomly assigned to isatuximab plus pom-dex (n = 154) or pom-dex only (n = 153). Patients had received a median of 3 prior lines of therapy at baseline.
The median follow-up was 35.3 months at the data cutoff of October 1, 2020. At this point, 27 (17.5%) patients in the isatuximab arm and 12 (7.8%) in the pom-dex arm were still receiving treatment. The median treatment duration was 47.6 weeks (range, 1.3-171.6) and 24.0 weeks (range, 1-168.6), respectively.
The median PFS was 11.1 months in the isatuximab arm and 5.8 months in the pom-dex arm (hazard ratio [HR], 0.599; P <.0001). The median PFS2 was 17.5 months and 12.9 months, respectively (HR, 0.759; P =.0202). The median overall survival was 24.6 months and 17.7 months, respectively (HR, 0.760; P =.0280).
The median time to next treatment was 15.5 months in the isatuximab arm and 8.9 months in the pom-dex arm (HR, 0.555; P <.0001). The proportion of patients who received subsequent treatment was 60% and 72%, respectively.
Among patients who proceeded to daratumumab alone or in combination with steroids, the overall response rate was higher in the pom-dex arm (37.9%) than in the isatuximab arm (14.3%). However, response rates were similar among patients who received daratumumab in combination with a proteasome inhibitor, immunomodulatory drug, or alkylating agent (30.8% with isatuximab and 31.8% with pom-dex only).
Overall, the rate of treatment-emergent adverse events (TEAEs) was similar between the treatment arms. The rate of grade 3 or higher TEAEs was higher in the isatuximab arm than in the pom-dex arm (90.8% vs 75.2%). However, the incidence of fatal TEAEs and TEAEs leading to treatment discontinuation was similar between the arms.
The most common non-hematologic, any-grade TEAEs in the isatuximab arm were infusion reaction (37.5%), upper respiratory tract infection (34.2%), and diarrhea (30.3%).
Rates of grade 3–4 hematologic adverse events that were higher in the isatuximab arm than in the pom-dex arm included anemia (34.9% vs 28.6%), neutropenia (84.9% vs 71.5%), and thrombocytopenia (34.2% vs 25.2%).
Disclosures: This research was supported by Sanofi. The presenter did not provide disclosures.
- Perrot A, Richardson P, San-Miguel J, et al. Updates from ICARIA-MM, a phase 3 study of isatuximab (isatuximab) plus pomalidomide and low-dose dexamethasone (pd) versus pd in relapsed and refractory multiple myeloma (RRMM). Paper presented at: European Hematology Association 2021 Virtual Congress; June 2021; Abstract S186.
- 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 Dec 7;394(10214):2096-2107. doi:10.1016/S0140-6736(19)32556-5
This article originally appeared on Cancer Therapy Advisor