The Phase 3 trial investigating Sarclisa® (isatuximab) in combination with carfilzomib, lenalidomide and dexamethasone (KRd) showed a statistically significant improvement in the rate of minimal residual disease (MRD) negativity, compared with KRd alone, after autologous stem cell transplant (ASCT) consolidation in transplant-eligible patients with newly diagnosed multiple myeloma (MM).
These results from the IsKia trial conducted by the European Myeloma Network (EMN) were presented during the oral plenary session at the American Society of Hematology (ASH) Annual Meeting by Francesca Gay, Associate Professor at the University Division of Hematology, University of Torino and Department of Molecular Biotechnology and Health Sciences – member of the Young EMN board of directors.
MRD negativity is defined as the absence of myeloma cells in the bone marrow after treatment, as measured by diagnostic techniques that must have a sensitivity of at least 1 in 100,000 cells. In this trial, MRD negativity was detected with a sensitivity of 10-5 (no cancer cells detected within 100,000 bone marrow cells) and 10-6 (no cancer cells detected within 1,000,000 bone marrow cells).
Peter Adamson, Global Development Head, Oncology, Sanofi:
“The statistically significant rates of MRD negativity observed with Sarclisa combination therapy further support our belief in Sarclisa as a potential best-in-class therapy. Effective front-line treatment is critical for newly diagnosed patients, because achieving undetectable levels of disease early in the treatment journey may lead to better long-term outcomes. We look forward to our continued collaboration with the EMN to explore the potential of this novel combination regimen for those with transplant-eligible, newly diagnosed multiple myeloma.”
The use of Sarclisa in combination with KRd in this patient population is investigational and has not been evaluated by any regulatory authority.
👉 Press Release: Sarclisa® (isatuximab) plus KRd significantly improved rate of minimal residual disease negativity in transplant-eligible patients with newly diagnosed multiple myeloma versus KRd alone (sanofi.com)
