| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | SLAMF7 (CD319) |
| Clinical data | |
| Trade names | Empliciti |
| Other names | HuLuc63 |
| License data | |
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| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Bioavailability | 100% (IV) |
| Identifiers | |
| CAS Number | |
| IUPHAR/BPS | |
| DrugBank |
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| ChemSpider |
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| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6476H9982N1714O2016S42 |
| Molar mass | 145453.59 g·mol−1 |
 N Y (what is this?) (verify) | |
Elotuzumab, sold under the brand nameEmpliciti, is a humanized IgG1monoclonal antibody medication used in combination withlenalidomide anddexamethasone, for adults that have received 1 to 3 prior therapies for the treatment ofmultiple myeloma.[3] It is also indicated for adult patients in combination withpomalidomide anddexamethasone, who have received 2 prior therapies including lenalidomide and aprotease inhibitor.[3] Administration of elotuzumab is doneintravenously.[3] Each intravenous injection of elotuzumab should be premedicated withdexamethasone,diphenhydramine,ranitidine andacetaminophen.[4] It is being developed byBristol Myers Squibb andAbbVie.[5]
Commonside effects of elotuzumab with lenalidomide and dexamethasone includesfatigue,diarrhea,pyrexia,constipation,cough,peripheral neuropathy,nasopharyngitis,upper respiratory tract infection, decreased appetite, andpneumonia.[3] The most common side effects of elotuzumab with pomalidomide and dexamethasone includesconstipation andhyperglycemia.[3] There is no available information for the use of elotuzumab inpregnant women.[3]
Elotuzumab is animmunostimulatory antibody that targets the Signaling Lymphocytic Activation Molecule Family member 7 (SLAMF7) through two mechanisms.[3]
In May 2014, it was grantedbreakthrough therapy designation by the USFood and Drug Administration (FDA) (for multiple myeloma).[6] The initialFDA approval of elotuzumab in 2015 in combination withlenalidomide anddexamethasone 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 theFDA approval of elotuzumab in combination withpomalidomide anddexamethasone in 2018.[9]
Elotuzumab is indicated for adult patients in combination treatment formultiple 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 asSLAMF7.[9] SLAMF7 is a cell surfaceglycoprotein that is present on myeloma cells,natural killer cells,plasma cells, and subsets of immune cells of thehematopoietic lineage.[9]
Elotuzumab works by activating thenatural killer cells through theSLAMF7 pathway.[3][9] Along with that, theSLAMF7 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 theefficacy and safety of elotuzumab. The objective of the study was to determine if the addition of elotuzumab withlenalidomide anddexamethasone would increaseprogression-free survival in patients with refractory multiple myeloma.[10][11] Thisrandomized,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 thecontrol 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 plusPomalidomide andDexamethasone 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 thecontrol 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]
