Idecabtagene vicleucel


Idecabtagene vicleucel is the first BCMA-directed CAR T-cell therapy for patients with relapsed/refractory multiple myeloma after 4 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.


In the phase 2 KarMMA trial, in which ide-cel elicited an overall response rate of 72% and a complete response rate of 28% in patients with relapsed/refractory myeloma who had received at least 4 prior treatments.


It is approved as a one-time infusion with a recommended dose range of 300 to 460 x 106 CAR-positive T cells.


About half of patients, or 51%, had high tumor burden, while 39% had extramedullary disease and 85% had 50% or higher tumor BCMA expression. 


Overall, participants had received a median of 6 previous treatments.


The majority of patients, or 94%, had undergone 1 previous autologous stem cell transplant; 34% had undergone more than 1 of these procedures. 


Ninety-four percent of patients proved to be refractory to anti-CD38 antibodies, and the majority, or 84%, were determined to be triple refractory.


Responses with ide-cel were rapid and durable.


The median time to response was 30 days and the median duration of response was 11 months for all responders and 19 months for those who achieved a complete remission.


Of the patients who achieved a complete remission, approximately 65% had remissions that lasted at least 1 year.


Its Boxed Warning:  cytokine release syndrome (CRS), neurologic toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and prolonged cytopenia.


Ide-cel was associated with mostly low-grade occurrence of cytokine release syndrome (CRS) and neurotoxicity (NT). 


Hrade 3 or higher CRS occurred in 9% of patients. 


The median duration of CRS was 7 days.


Any-grade and grade 3 or higher NT occurred in 28% and 4% of patients, respectively. 


A, hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) occurred in 4% of patients.


Forty-one percent and 49% of patients experienced prolonged grade 3/4 neutropenia and thrombocytopenia, respectively. 


Prolonged cytopenia can occur and lead to fatality.


Common, (≥20%), types of adverse events (AEs) included CRS, infections, fatigue, musculoskeletal pain, hypogammaglobulinemia, diarrhea, upper respiratory tract infection, nausea, viral infections, encephalopathy, edema, pyrexia, cough, headache, and decreased appetite.


Serious AEs occurred in 67% of patients; the most common (≥5%) were CRS (18%), general physical health deterioration (10%), pneumonia (12%), infections (19%), viral infections (9%), sepsis (7%), and febrile neutropenia (6%). 


The most common grade 3/4 nonlaboratory adverse reactions were febrile neutropenia (16%) and infections (14%). 


Fatal adverse events  were reported in 6% of patients.





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