Philippe Moreau, MD, professor of clinical hematology, Nantes Faculty of Medicine, head, Translational Research Program, University Hospital of Nantes, University of Nantes, France, discusses the FDA approval of isatuximab-irfc (Sarclisa) plus carfilzomib (Kyprolis) and dexamethasone (Kd) in relapsed/refractory multiple myeloma.

On March 31, 2021, the FDA approved isatuximab plus Kd for the treatment of patients with relapsed/refractory multiple myeloma who have previously received 1 to 3 prior lines of therapy. On April 19, 2021, the European Commission approved the combination for use in patients with relapsed multiple myeloma who received at least 1 prior therapy.

Both regulatory decisions were based on findings from the phase 3 IKEMA trial, which demonstrated a 45% reduction in the risk of disease progression or death with the triplet vs Kd alone in this patient population.

As such, isatuximab plus Kd could be considered a new standard of care option for patients in their first or second relapse, particularly for patients who are refractory to lenalidomide (Revlimid), concludes Moreau.

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Philippe Moreau, MD, discusses the FDA approval of isatuximab-irfc plus carfilzomib and dexamethasone in relapsed/refractory multiple myeloma.  



Dr. Moreau on the FDA Approval of Isatuximab Plus Carfilzomib/Dexamethasone in Multiple Myeloma 

Philippe Moreau, MD, head of the Hematology Department, University Hospital of Nantes, France, discusses the combination treatments being used to treat patients with multiple myeloma.

The triplet combinations that patients with multiple myeloma are receiving are mainly based on the findings of several large phase II and III randomized studies. According to Moreau, bortezomib (Velcade) and dexamethasone serve as the backbone of the basic treatment regimen for these patients. Thus, triplet combinations almost always include these 2 agents, and the common third drugs used for these patients include lenalidomide (Revlimid), cyclophosphamide, thalidomide (Thalomid), and doxorubicin.

Moreau speculates that carfilzomib (Kyprolis) may replace bortezomib in such treatment combinations, though he notes that the toxicities associated with that agent tend to present more issues for patients.

He also suggests that the future may see not just triplet combinations, but quadruplet combination therapies as well, which would likely include monoclonal antibodies such as daratumumab (Darzalex) on top of the already established triplet combinations.

Dr. Moreau on Combination Treatments in Multiple Myeloma

Philippe Moreau, MD, head of Department of Hematology, Centre Hospitalier et Universitaire, Nantes, France, discusses the phase III Tourmaline-MM1 study for patients with relapsed/refractory multiple myeloma.

The prospective, randomized, double-blind, placebo-controlled study compared lenalidomide and dexamethasone plus ixazomib versus lenalidomide and dexamethasone plus placebo. The trial’s primary endpoint was progression-free survival (PFS). There were 722 patients enrolled in the study who had relapsed/refractory disease and who received one to three prior lines of therapy.

Results showed that the duration of response and PFS were both improved in patients in the ixazomib arm. Median PFS increased to 20.6 months from 14.7 months without a substantial increase in overall toxicity, Moreau says. All subgroups of patients benefitted from the addition of ixazomib, including those with high-risk cytogenetics and 17p deletion, he adds.

Philippe Moreau, MD, head of Department of Hematology, Centre Hospitalier et Universitaire, Nantes, France, discusses the phase III Tourmaline-MM1 study for patients with relapsed/refractory multiple myeloma. 


Philippe Moreau, MD

Articles

Dr. Moreau on the FDA Approval of Isatuximab Plus Carfilzomib/Dexamethasone in Multiple Myeloma

Dr. Moreau on Combination Treatments in Multiple Myeloma

Dr. Moreau on Tourmaline-MM1 Study for Multiple Myeloma