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On March 31, 2021, the U.
S.
Food and Drug Administration (FDA) approved the combination of isatuximab-irfc with carfilzomib and dexamethasone to treat relapsed/refractory multiple bone marrow that has previously received 1-3 lines of treatment Adult patients with tumors (RRMM).
The IKEMA study (NCT03275285) is a multi-country, multi-center, randomized, open-label, dual-arm, phase 3 study that evaluated isatuximab-irfc combined with carfilzomib and dexamethasone in RRMM patients who have previously received 1-3 lines of treatment The efficacy and safety.
In the study, 302 patients were randomly assigned to receive isatuximab-irfc combined with carfilzomib and dexamethasone (Isa-Kd) treatment or carfilzomib and dexamethasone (Kd) treatment at a ratio of 3:2.
The main efficacy indicator is the progression-free survival (PFS) assessed by the independent review committee.
The median PFS in the Isa-Kd group was not reached, and the median PFS in the Kd group was 20.
27 months (95% CI: 15.
77-NR) (HR: 0.
548; 95% CI: 0.
366-0.
822; p=0.
0032), compared with patients in the Kd group In comparison, the risk of disease progression or death in the Isa-Kd group was reduced by 45%.
The most common (≥20%) adverse reactions in patients receiving Isa-Kd are upper respiratory tract infection, infusion-related reactions, fatigue, high blood pressure, diarrhea, pneumonia, dyspnea, insomnia, bronchitis, cough, and back pain.
The most common (≥80%) hematology laboratory abnormalities are hemoglobin reduction, lymphopenia and thrombocytopenia.
When combined with carfilzomib and dexamethasone, the recommended dose of Isatuximab-irfc is 10 mg/kg, intravenously infused once a week for 4 weeks, and then every two weeks until the disease progresses or intolerable toxicity .
Reference source:Stamp "read the original text" and we will make progress together
S.
Food and Drug Administration (FDA) approved the combination of isatuximab-irfc with carfilzomib and dexamethasone to treat relapsed/refractory multiple bone marrow that has previously received 1-3 lines of treatment Adult patients with tumors (RRMM).
The IKEMA study (NCT03275285) is a multi-country, multi-center, randomized, open-label, dual-arm, phase 3 study that evaluated isatuximab-irfc combined with carfilzomib and dexamethasone in RRMM patients who have previously received 1-3 lines of treatment The efficacy and safety.
In the study, 302 patients were randomly assigned to receive isatuximab-irfc combined with carfilzomib and dexamethasone (Isa-Kd) treatment or carfilzomib and dexamethasone (Kd) treatment at a ratio of 3:2.
The main efficacy indicator is the progression-free survival (PFS) assessed by the independent review committee.
The median PFS in the Isa-Kd group was not reached, and the median PFS in the Kd group was 20.
27 months (95% CI: 15.
77-NR) (HR: 0.
548; 95% CI: 0.
366-0.
822; p=0.
0032), compared with patients in the Kd group In comparison, the risk of disease progression or death in the Isa-Kd group was reduced by 45%.
The most common (≥20%) adverse reactions in patients receiving Isa-Kd are upper respiratory tract infection, infusion-related reactions, fatigue, high blood pressure, diarrhea, pneumonia, dyspnea, insomnia, bronchitis, cough, and back pain.
The most common (≥80%) hematology laboratory abnormalities are hemoglobin reduction, lymphopenia and thrombocytopenia.
When combined with carfilzomib and dexamethasone, the recommended dose of Isatuximab-irfc is 10 mg/kg, intravenously infused once a week for 4 weeks, and then every two weeks until the disease progresses or intolerable toxicity .
Reference source:Stamp "read the original text" and we will make progress together
