Monoclonal antibody | |
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Type | Whole antibody |
Source | Humanized |
Target | SLAMF7 (CD319) |
Clinical data | |
Trade names | Empliciti |
Other names | HuLuc63 |
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Routes of administration | Intravenous |
ATC code | |
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Pharmacokinetic data | |
Bioavailability | 100% (IV) |
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Chemical and physical data | |
Formula | C6476H9982N1714O2016S42 |
Molar mass | 145453.59 g·mol−1 |
NY (what is this?) (verify) |
Elotuzumab, sold under the brand name Empliciti, is a humanized IgG1 monoclonal antibody medication used in combination with lenalidomide and dexamethasone, for adults that have received 1 to 3 prior therapies for the treatment of multiple myeloma.[3] It is also indicated for adult patients in combination with pomalidomide and dexamethasone, who have received 2 prior therapies including lenalidomide and a protease inhibitor.[3] Administration of elotuzumab is done intravenously.[3] Each intravenous injection of elotuzumab should be premedicated with dexamethasone, diphenhydramine, ranitidine and acetaminophen.[4] It is being developed by Bristol Myers Squibb and AbbVie.[5]
Common side effects of elotuzumab with lenalidomide and dexamethasone includes fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, and pneumonia.[3] The most common side effects of elotuzumab with pomalidomide and dexamethasone includes constipation and hyperglycemia.[3] There is no available information for the use of elotuzumab in pregnant women.[3]
Elotuzumab is an immunostimulatory antibody that targets the Signaling Lymphocytic Activation Molecule Family member 7 (SLAMF7) through two mechanisms.[3]
In May 2014, it was granted breakthrough therapy designation by the US Food and Drug Administration (FDA) (for multiple myeloma).[6] The initial FDA approval of elotuzumab in 2015 in combination with lenalidomide and dexamethasone was carried out through the results illustrated in the ELOQUENT 2 study.[7] In May 2016 the EC/EU gave a similar approval.[8] Furthermore, the results of the ELOQUENT 3 study led to the FDA approval of elotuzumab in combination with pomalidomide and dexamethasone in 2018.[9]
Elotuzumab is indicated for adult patients in combination treatment for multiple myeloma in patients that have received 1 to 3 prior therapies.[3] For medical use in multiple myeloma patients, elotuzumab can be combined with either lenalidomide and dexamethasone or pomalidomide and dexamethasone.[3]
The package insert advises that intravenous administration with 10 mg/kg every week for the first 2 cycles (each cycle is 28 days) and every 2 weeks thereafter, with the appropriate doses of lenalidomide and low dose dexamethasone is acceptable for treatment.[3] For additional information on dosing dexamethasone and/or lenalidomide, refer to the package inserts.[3]
Elotuzumab is recommended through intravenous administration at 10 mg/kg each week for the first 2 cycles (each cycle is 28 days).[3] At the start of cycle 3, administer 20 mg/kg every 4 weeks, while administering the recommended dose of pomalidomide and low dose dexamethasone.[3] For additional information on dosing dexamethasone and/or dexamethasone, refer to the package inserts.[3]
To evaluate the adverse reactions in the Eloquent 2 trial, elotuzumab was combined with lenalidomide and dexamethasone and compared with lenalidomide and dexamethasone alone.[3][10][11] The most common adverse reactions (20% or higher) denoted in the elotuzumab treated patients in the study were:[3][10][11]
Similarly, the adverse reactions in the Eloquent 3 trial were examined by comparing the elotuzumab combined with pomalidomide and dexamethasone with the pomalidomide and dexamethasone alone.[3][12][13]
Elotuzumab is an immunostimulatory antibody that targets signaling lymphocyte activation molecule family member 7, also known as SLAMF7.[9] SLAMF7 is a cell surface glycoprotein that is present on myeloma cells, natural killer cells, plasma cells, and subsets of immune cells of the hematopoietic lineage.[9]
Elotuzumab works by activating the natural killer cells through the SLAMF7 pathway.[3][9] Along with that, the SLAMF7 of the myeloma cells are targeted and flagged, for natural killer cell-mediated destruction through antibody-dependent cellular toxicity.[3][9]
The trial, Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma, also known as the Eloquent 2 trial, studied the efficacy and safety of elotuzumab. The objective of the study was to determine if the addition of elotuzumab with lenalidomide and dexamethasone would increase progression-free survival in patients with refractory multiple myeloma.[10][11] This randomized, open-label, phase 3, multicenter trial studied patients 18 years and older with multiple myeloma and measurable disease.[10] With 321 patients designated to the elotuzumab group and 325 to the control group, the elotuzumab group had a significant relative reduction in the risk of disease progression or death.[10] The median progression-free survival for the elotuzumab group was 19.4 months compared with 14.9 months in the control group.[10] Additionally, the response rate for the etoluzumab group was 79%, compared to the control group with 66%.[10]
In the Eloquent 3 trial, also known as Elotuzumab plus Pomalidomide and Dexamethasone for Multiple Myeloma, 117 patients with refractory or relapsed multiple myeloma, and were refractory to lenalidomide and a protease inhibitor, were randomized to either the elotuzumab group or the control group.[12] The elotuzumab group, with 60 patients, received elotuzumab with pomalidomide and dexamethasone and the control group, with 57 patients, received pomalidomide and dexamethasone alone.[12] Among patients that had failed treatment with lenalidomide and a protease inhibitor, death or risk of progression was significantly lower in the elotuzumab study arm.[12] The median progression-free survival in the elotuzumab study arm was 10.3 months compared to 4.7 months in the control study group, after a 9.1 month follow up period.[12]
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