ICARIA-MM: Updated Results With Isatuximab-Based Therapy for Resistant Myeloma
Posted: Friday, August 13, 2021
Paul G. Richardson, MD, of the Dana-Farber Cancer Institute, Boston, and colleagues tested the CD38 monoclonal antibody isatuximab plus pomalidomide with low-dose dexamethasone versus pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. These updated ICARIA-MM results, presented during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 8017), demonstrated a “significant improvement” in progression-free survival and time to next treatment in patients receiving isatuximab versus those who did not, with a consistent safety profile.
This phase III study enrolled 307 patients with relapsed and refractory multiple myeloma who received two or more prior therapies. Patients were randomly assigned to receive pomalidomide and dexamethasone with (n = 154) or without (n = 153) isatuximab. Patients were administered intravenous isatuximab at 10 mg/kg weekly for 4 weeks and then every other week after that.
At a median follow-up of 35.3 months, 27 patients given isatuximab plus pomalidomide and dexamethasone and 12 patients given pomalidomide and dexamethasone remained on treatment; 60% and 72%, respectively, moved to subsequent therapy. The median time to next treatment was longer for those treated with isatuximab than those who were not (15.5 vs. 8.9 months); 24% of patients on the isatuximab combination versus 58% of those on pomalidomide and dexamethasone alone received subsequent treatment with the monoclonal antibody daratumumab.
The median progression-free survival (17.5 vs. 12.9 months), overall survival (24.6 vs. 17.7 months), and treatment duration (47.6 vs. 24.0 weeks) were all higher with isatuximab than without it. Patients treated with isatuximab experienced nonhematologic treatment-emergent adverse events such as infusion reaction, upper respiratory tract infections, and diarrhea; grade 3 to 4 thrombocytopenia and neutropenia occurred more frequently in these patients as well.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.