EHA25 Virtual: Adding Isatuximab to Front-Line Standard of Care in High-Risk Myeloma
Posted: Thursday, July 2, 2020
Induction with the four-drug combination of the monoclonal anti-CD38 antibody isatuximab plus carfilzomib, lenalidomide, and dexamethasone (KRd) appears to induce deep responses—including many patients with minimal residual disease negativity—in previously untreated high-risk multiple myeloma. As for toxicity, Katja Weisel, MD, of the University of Hamburg-Eppendorg, Germany, and colleagues reported consistent overall safety profile with previous reports. The interim analysis of the phase II GMMG-CONCEPT trial was presented during the virtual edition of the 25th European Hematology Association Annual Congress (EHA25 Virtual; Abstract S204).
The analysis included 50 patients with high-risk multiple myeloma, defined as the presence of: del17p (52%), t(4;14) (38%), or t(14;16) (12%) mutation; more than three copies of 1q21 (42%); or International Staging System stage 2 or 3 disease. All patients were scheduled to receive six cycles of the four-drug regimen as induction, four cycles of it as consolidation, and then as maintenance. When eligible for transplantation (n = 46), patients underwent high-dose therapy, whereas patients who were ineligible for transplantation (n = 4) received two additional cycles of isatuximab plus KRd as induction.
Induction therapy was completed in 39 patients in the transplantation-eligible and in 4 patients in the transplantation-ineligible arms, respectively. The overall response rate was 100%, with a partial remission in 10%, a very good partial response in 44%, and a complete remission in 46%. In 30 patients who achieved at least a very good partial response, minimal residual disease negativity was observed in 20 patients (67%).
As for safety, grade 3 and 4 treatment-related adverse events included neutropenia (34%), leukopenia (26%), thrombocytopenia (14%), and hypertension (12%).
Disclosure: For study authors’ disclosures, visit library.ehaweb.org.
