Isatuximab Combination Therapy for Relapsed or Refractory Multiple Myeloma
In heavily pretreated patients with relapsed or refractory multiple myeloma, the anti-CD38 monoclonal antibody isatuximab (also known as SAR650984), in combination with pomalidomide and dexamethasome, was clinically active, according to data from a phase Ib study presented by Joseph Mikhael, MD, of Mayo Clinic Phoenix, at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 8007). Based on these data, a phase III trial of this combination is ongoing (ClinicalTrials.gov identifier NCT02283775).
A total of 26 patients with a median of 4 prior treatment regimens took part in the study. Eight patients were enrolled to a 5-mg/kg dose; 12 patients, to a 10-mg/kg dose; and 6 patients, to a 20-mg/kg dose, at 4 weekly doses to start and then every 2 weeks until disease progression or intolerable toxicity. The patients were also given pomalidomide at 4 mg and dexamethasone at 40 mg in 28-day cycles.
The median duration of isatuximab treatment was 19 weeks. The median time to first response was 4.2 weeks, and the median duration of response was 25.6 weeks.
Dose-limiting toxicities were reported in one patient at each dose level, and the maximum tolerated dose has not yet been reached. A total of 62% of patients achieved at least a partial response, including 1 complete response, 8 very good partial responses, and 7 partial responses.