Isatuximab (Sanofi/ImmunoGen) is a humanized monoclonal antibody which targets cancer cells expressing the transmembrane glycoprotein CD38, which is highly expressed on malignant multiple myeloma (MM) cells, but at low levels in other tissues. Although the drug’s exact mechanisms of action are not fully understood, evidence indicates that it acts as an immune-modulatory agent that is able to activate natural killer cells and monocyte activation. By binding to CD38, myeloma cell death is induced by several different mechanisms, including apoptosis and antibody- and complement-dependent cytotoxicity.
Initial approvals in the relapsed/refractory settings would make isatuximab the second CD38-directed monoclonal antibody therapy to enter the market, and would place it in direct competition with more established therapies such as Darzalex (daratumumab; Johnson & Johnson), Farydak (panobinostat; Novartis), Kyprolis (carfilzomib; Amgen/Ono Pharmaceutical), Ninlaro (ixazomib; Takeda), and Pomalyst (pomalidomide; Celgene). Therefore, Datamonitor Healthcare expects that isatuximab will initially be relegated to later lines of therapy. Ultimately, however, the drug is likely to gain the most uptake and maximize its commercial potential in the first-line setting, where it is being developed in combination with standards-of-care Velcade (bortezomib; Takeda/Johnson & Johnson), Revlimid (lenalidomide; Celgene), and dexamethasone for patients who are ineligible for stem cell transplantation (ClinicalTrials.gov identifier: NCT03319667).
LIST OF FIGURES
11 Figure 1: Isatuximab for multiple myeloma – SWOT analysis
12 Figure 2: Datamonitor Healthcare’s drug assessment summary for isatuximab in multiple myeloma
13 Figure 3: Datamonitor Healthcare’s drug assessment summary for isatuximab in multiple myeloma
15 Figure 4: Isatuximab sales for multiple myeloma across the US, Japan, and five major EU markets, by country, 2017–26
LIST OF TABLES
6 Table 1: isatuximab drug profile
7 Table 2: isatuximab Phase III trial in multiple myeloma
10 Table 3: Isatuximab Phase I/II data in multiple myeloma
16 Table 4: Isatuximab sales for multiple myeloma across the US, Japan, and five major EU markets, by country ($m), 2017–26
18 Table 5: Patients treated with isatuximab across the US, Japan, and five major EU markets, by country, 2017–26
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