FDA Approves a Drug Containing Isatuximab-irfc for Multiple Myeloma

For adults who had received at least two previous therapies, including lenalidomide and a proteasome inhibitor, the drug isatuximab-irfc (Sarclisa) for multiple myeloma in combination with pomalidomide and dexamethasone received, on 2 March 2020, United States Food and Drug Administration (FDA) approval.

How Does Isatuximab Work?

Isatuximab, targeting the CD38 receptor at a specific epitope, is a monoclonal antibody (mAb). Programmed tumor cell death (apoptosis) and immunomodulatory activity are thought to be directly promoted by the multiple, distinct mechanisms of action it is designed to trigger.

The ICARIA-MM Clinical Trial

The efficacy of the monoclonal antibody isatuximab-irfc was evaluated in ICARIA-MM, a multicenter, multinational, randomized, open-label, two-arm phase 3 study in 307 patients with relapsed and refractory multiple myeloma who had received at least two previous therapies, including lenalidomide and a proteasome inhibitor. Patients were randomized in a 1:1 ratio to receive isatuximab-irfc with pomalidomide and low-dose dexamethasone (Isa-Pd, 154 patients) or pomalidomide and low-dose dexamethasone. The primary efficacy outcome measure, assessed by an independent committee using central laboratory data for M-protein and a central review of radiological imaging based on International Myeloma Working Group criteria, was progression-free survival (PFS). The improvement in PFS represented a 40% reduction in the risk of disease progression or death in patients treated with Isa-Pd (HR 0.596; 95% CI: 0.44-0.81; p = 0.0010). The average PFS was 11.53 months (95% CI: 8.94-13.9) for patients receiving Isa-Pd and 6.47 months (95% CI: 4.47-8.28) for those receiving Pd. The most common (in ≥20% of patients) adverse reactions were neutropenia, infusion-related reactions, pneumonia, upper respiratory tract infection and diarrhea. The recommended isatuximab-irfc dose is 10 mg / kg as an intravenous infusion every week for 4 weeks. Administration continues every 2 weeks in combination with pomalidomide and dexamethasone until disease progression or unacceptable toxicity.