SOHO 2020: Fixed-Volume Isatuximab in Resistant Multiple Myeloma
Posted: Wednesday, September 23, 2020
According to the final results from Part B of a phase Ib study presented at the 2020 Society of Hematologic Oncology (SOHO) Annual Meeting (Abstract MM-096), isatuximab appears to be safe and effective in the treatment of patients with relapsed or refractory multiple myeloma when administered through fixed-volume infusion in conjunction with pomalidomide and dexamethasone. These results were consistent with the findings of the dose-escalation process conducted in Part A.
“The fixed infusion volume administration of isatuximab reduced the time of infusion by > 60 minutes for the second infusion and > 90 minutes for subsequent infusions,” concluded Paul G. Richardson, MD, of the Dana-Farber Cancer Institute, and colleagues. “The reduced infusion times of isatuximab make it the shortest [intravenous] infusion times of any approved anti-CD38 monoclonal antibody…”
The study included 46 patients with relapsed or refractory multiple myeloma who had received at least two prior lines of therapy and had experienced disease progression during or following their most recent therapy. The median number of treatment cycles was nine, the median duration of exposure was 36.9 weeks, and the median time to first response was 0.95 months. Median progression-free survival and overall survival were not reached. The 6-month and 12-month probabilities were 65% and 56%, respectively, for progression-free survival and 84% and 71%, respectively, for overall survival.
A total of 19 patients (40.4%) experienced a grade 2 infusion reaction during their initial infusion alone. Dose interruptions were performed for 18 patients, and 17 were treated with medication. All patients experienced at least one treatment-related adverse event, and the majority of patients (74.5%) experienced adverse events of at least grade 3. Fatigue, infusion reactions, cough, and upper respiratory tract infections were the most commonly occurring nonhematologic adverse events. Hematologic laboratory abnormalities were experienced by 100% of patients and led to five patients discontinuing treatment.
Disclosure: No disclosures for the study authors were provided.