Adding isatuximab to carfilzomib and dexamethasone therapy for the treatment of relapsed multiple myeloma.

This study evaluated the effectiveness and safety of adding isatuximab (Sarclisa) to carfilzomib (Kyprolis) and dexamethasone (Decadron) combination (Kd) for patients with previously treated relapsed multiple myeloma (MM). The data showed that adding isatuximab to the Kd regimen reduced the risk of disease progression or death for these patients.

Multiple myeloma (MM) is a type of cancer that comes from blood cells called plasma cells. A high number of patients with MM experience relapse (the tumor grows after treatment) or are refractory (not responsive to the treatment) to standard treatments. Currently, the treatment strategies for r/r MM are based on the different combinations of conventional drugs and novel drugs.

One standard treatment combination for r/r MM is pomalidomide (Pomalyst) in combination with dexamethasone (Pd). Isatuximab is an immunotherapy drug that has been approved for the treatment of r/r MM. It has been shown to improve the outcomes of these patients when combined with Pd therapy. Carfilzomib is a proteasome inhibitor. Proteasomes are large molecules present in all body cells. It blocks the action of proteasomes, therefore preventing cancer cells from growing and multiplying. Carfilzomib and dexamethasone (Kd) are commonly used together to treat r/r MM. However, the effectiveness and safety of adding isatuximab to Kd therapy for patients with previously treated relapsed MM remain under investigation.

The study involved 302 patients with previously treated relapsed MM. Patients were randomly assigned into 2 groups. Group 1 included 179 patients who received isatuximab + Kd treatment. Group 2 included 123 patients who received only Kd treatment. The average follow-up time was 20.7 months.

The average survival without progression or cancer worsening was not reached (longer than the analysis time) in group 1 compared to 19.15 months in group 2. Patients in group 1 were 47% less likely to have progression or worsening of cancer than patients in group 2. After 2 years, 68.9% of the patients in group 1 were alive without disease progression compared to 45.7% of the patients in group 2.

Overall, 87% of the patients in group 1 responded to the treatment compared to 83% of the patients in group 2. The partial response rate (partial removal of cancer cells) was 73% for group 1 compared to 56% for group 2. The complete response rate (complete removal of cancer cells) was 40% for group 1 compared to 28% for group 2.

77% of the patients in group 1 experienced severe treatment-related side effects compared to 67% of patients in group 2. The most common side effects were high blood pressure, diarrhea, and respiratory infections. 

This study concluded that adding isatuximab to carfilzomib and dexamethasone regimen significantly reduced the risk of disease progression or death for the treatment of patients with previously treated relapsed MM. The authors suggest that this treatment regimen should be the new standard of care in these patients.

This study was sponsored by Sanofi, the manufacturers of isatuximab.