Adding isatuximab to pomalidomide-dexamethasone therapy for relapsed/refractory multiple myeloma.

The aim of this study was to evaluate the addition of isatuximab (Sarclisa) to pomalidomide (Pomalyst) and dexamethasone (Decadron) therapy for patients with relapsed/refractory (r/r) multiple myeloma (MM). The study found that patients who were given isatuximab had a better outcome.

MM is a type of blood cancer that impacts bone marrow. Therapy for MM can include targeted therapy (TT), immunotherapy (IT), and chemotherapy (CT). There are many combinations of these types of therapy available for patients with MM. However, some patients do not respond to therapy (refractory MM). Some patients see a disease progression even after they have had a response to therapy (relapsed MM).

For patients with r/r MM, new combination therapies are being explored. The combination of pomalidomide and dexamethasone (Pd) is common in patients with r/r MM. Isatuximab is an immunotherapy drug that has been approved for the treatment of r/r MM. It has proven to improve the outcomes of these patients when combined with Pd therapy. However, it is not currently known whether the effectiveness of this combination therapy depends on the previous therapy given to patients.

The study evaluated data from 307 patients with r/r MM. 154 patients received isatuximab + Pd (group 1). 153 patients were given Pd alone (group 2). 66% of both groups had received 2-3 different types of therapy before and 34% had previously received more than 3 types of therapy. The average follow-up time was 11.6 months.

Overall, patients in group 1 had a significantly longer duration of survival without disease worsening (11.53 months) compared to 6.47 months in group 2. The addition of isatuximab to Pd therapy was associated with a 40.4% lower risk of disease worsening compared to Pd alone. This benefit was seen in all patients, regardless of the type of therapy they had received before.

Patients in group 1 had a higher response rate than those in group 2, regardless of their previous therapy. For patients who had more than 3 types of prior therapy, 67.3% of patients in group 1 responded compared to 28.6% patients in group 2.

99.3.% of patients in group 1 and 98% of patients in group 2 reported at least one side effect. The most common reported side effects were respiratory infections, diarrhea, nausea, constipation, and back pain.

The study concluded that patients with r/r MM treated with isatuximab added to Pd therapy had a better outcome, regardless of the type of therapy they received before.

The study was funded by Sanofi who manufactures isatuximab. The study was not randomized. Patients knew what therapy they were getting. Also, the follow-up time was quite short.