Isatuximab (Sarclisa®; isatuximab-irfc in the USA) is an anti-CD38 monoclonal antibody (mAb) approved for use in the treatment of adults with multiple myeloma (MM): in combination with pomalidomide and dexamethasone for those with relapsed and refractory MM (RRMM) who have received ≥ 2 prior therapies, including lenalidomide and a proteasome inhibitor; and in combination with carfilzomib and dexamethasone for those with relapsed MM who have received ≥ 1 prior therapy. In phase III studies, the addition of isatuximab to pomalidomide and dexamethasone significantly prolonged progression-free survival (PFS) and improved the depth of tumour response in patients with RRMM, as did the addition of isatuximab to carfilzomib and dexamethasone in patients with relapsed or refractory MM. Health-related quality of life was maintained when isatuximab was combined with these other therapies. Isatuximab-based combination therapies were generally well tolerated and demonstrated a manageable safety profile with no new safety signals. Although mature overall survival data are awaited, available evidence indicates that the combinations of isatuximab with pomalidomide and dexamethasone and isatuximab with carfilzomib and dexamethasone are important additional treatment options for RRMM and relapsed MM, respectively.
The introduction of immunomodulatory drugs (IMiDs) protease inhibitors (PIs) and anti-CD38 monoclonal antibodies (mAbs) has improved survival in patients with multiple myeloma (MM) to the extent that this haematological malignancy is no longer viewed as an incurable disease, but rather as a manageable chronic condition characterized by multiple relapses and salvage therapies. Isatuximab (Sarclisa®; isatuximab-irfc in the USA) is an anti-CD38 mAb approved for use in adult patients with relapsed/refractory MM (RRMM) and relapsed MM. Isatuximab prolonged progression-free survival (PFS) and increased the frequency and/or depth of tumour response when added to pomalidomide and dexamethasone in adults with RRMM who had received ≥ 2 previous lines of treatment (ICARIA-MM trial), and when added to carfilzomib and dexamethasone in adults with relapsed or refractory MM who had received ≥ 1 previous lines of treatment (IKEMA trial). Final overall survival (OS) data from both trials are awaited. Both isatuximab-based combination therapies had manageable safety profiles, with no new safety signals identified. Health-related quality of life was preserved. Currently available data indicate that the combinations of isatuximab with pomalidomide–dexamethasone and carfilzomib–dexamethasone are important additional treatment options for adults with RRMM and relapsed MM, respectively.
© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.