The Food and Drug Administration (FDA) has approved Sarclisa (isatuximab-irfc; Sanofi), in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor.
Sarclisa is an IgG1-derived monoclonal antibody that works by binding to CD38 receptors on multiple myeloma cells. The approval was based on data from the multicenter, randomized, open-label, phase 3 ICARIA-MM study that compared Sarclisa plus pomalidomide and low-dose dexamethasone (Isa-Pd) or pomalidomide and low-dose dexamethasone (Pd) in 307 patients with multiple myeloma who had received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor.
Patients were randomized 1:1 to receive either Sarclisa 10mg/kg by intravenous (IV) infusion plus pomalidomide and low-dose dexamethasone (Isa-Pd) or pomalidomide and low-dose dexamethasone (Pd) until disease progression or unacceptable toxicity. The primary end point was the progression free survival (PFS).
Findings from the study showed a statistically significant improvement in PFS with Isa-Pd vs Pd, with a 40% reduction in the risk of disease progression or death (HR 0.596; 95% CI, 0.44-0.81; P=.001); median PFS for the Isa-Pd arm was 11.53 months (95% CI, 8.94-13.9) vs 6.47 months (95% CI, 4.47-8.28) for the Pd arm. Additionally, patients treated with Isa-Pd demonstrated a greater overall response rate vs Pd (60.4% vs 35.3%; P <.0001).
With regard to safety, the most common adverse reactions (≥20%) were neutropenia, infusion-related reactions, pneumonia, upper respiratory tract infection, and diarrhea. The most common hematology lab abnormalities included anemia, neutropenia, lymphopenia, and thrombocytopenia.
“The pivotal ICARIA-MM trial was the first phase 3 study of a CD38 antibody in combination with [pomalidomide and dexamethasone] to present results demonstrating significant clinical benefit in this setting,” said Paul Richardson, MD, principal investigator of ICARIA-MM, and clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute. “The study enrolled a broad population of patients with relapsed and refractory multiple myeloma that is particularly difficult to treat and with poor prognosis, which is reflective of real-world practice.”
Sarclisa will be available soon in 100mg/5mL and 500mg/25mL single-dose vials for IV infusion.
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