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Empliciti (elotuzumab) - 2 indications
Scroll down for more information on each indication:
- for use in combination with two other therapies for the treatment of adult patients with multiple myeloma who have received one to three prior therapies; approved November of 2015
- for use combination with two other therapies for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor; approved November of 2018
General Information
Empliciti (elotuzumab) is a SLAMF7-directed immunostimulatory antibody.
Empliciti is specifically indicated:
- for use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies
- for use in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor
Empliciti is supplied as a solution for intravenous administration. Scroll down for dosing information for each indication.
The recommended dose is 10 mg/kg administered intravenously every week for the first two cycles and every 2 weeks thereafter in conjunction with the recommended dosing of lenalidomide and low-dose dexamethasone. Continue treatment until disease progression or unacceptable toxicity.
Mechanism of Action
Empliciti (elotuzumab) is a humanized IgG1 monoclonal antibody that specifically targets the SLAMF7 (Signaling Lymphocytic Activation Molecule Family member 7) protein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 is also expressed on Natural Killer cells, plasma cells, and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage. Elotuzumab directly activates Natural Killer cells through both the SLAMF7 pathway and Fc receptors. Elotuzumab also targets SLAMF7 on myeloma cells and facilitates the interaction with Natural Killer cells to mediate the killing of myeloma cells through antibody-dependent cellular cytotoxicity (ADCC).
Side Effects
Adverse effects associated with the use of Empliciti plus lenalidomide and dexamethasone may include, but are not limited to, the following:
- fatigue
- diarrhea
- pyrexia
- constipation
- cough
- peripheral neuropathy
- nasopharyngitis
- upper respiratory tract infection
- decreased appetite
- pneumonia
Adverse effects associated with the use of Empliciti plus pomalidomide and dexamethasone may include, but are not limited to, the following:
- constipation
- hyperglycemia
Indication 1 - in combination with lenalidomide and dexamethasone for patients with multiple myeloma who have received one to three prior therapies
approved November of 2015
Dosing/Administration
With lenalidomide and dexamethasone: 10 mg/kg administered intravenously every week for the first two cycles and every 2 weeks thereafter until disease progression or unacceptable toxicity
Clinical Trial Results
The FDA approval of Empliciti was based on ELOQUENT-2, a randomized, open-label study. Subjects received either Empliciti in combination with lenalidomide and low-dose dexamethasone (ERd) or lenalidomide and low-dose dexamethasone. Treatment was administered in 4-week cycles until disease progression or unacceptable toxicity. Empliciti 10 mg/kg was administered intravenously each week for the first 2 cycles and every 2 weeks thereafter. Prior to Empliciti infusion, dexamethasone was administered as a divided dose: an oral dose of 28 mg and an intravenous dose of 8 mg. In the control group and on weeks without Empliciti, dexamethasone 40 mg was administered as a single oral dose weekly. Lenalidomide 25 mg was taken orally once daily for the first 3 weeks of each cycle. Assessment of tumor response was conducted every 4 weeks. The co-primary endpoints were progression-free survival (PFS) and overall response rate (ORR). With a minimum of two years follow-up, ERd delivered a benefit in PFS that was maintained over time, with PFS rates of 68% versus 57% at one year and 41% versus 27% at two years in the ERd and Rd arms, respectively. The ERd regimen also demonstrated a significant improvement in ORR, achieving an ORR of 78.5% versus 65.5% in the Rd arm.
Indication 2- in combination with pomalidomide and dexamethasone for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor
approved November of 2018
Dosing/Administration
With pomalidomide and dexamethasone: 10 mg/kg administered intravenously every week for the first two cycles and 20 mg/kg every 4 weeks thereafter until disease progression or unacceptable toxicity
Clinical Trial Results
FDA approval was based on ELOQUENT-3, a randomized, open-label, Phase 2 trial. The combination demonstrated benefit in patients with relapsed or refractory multiple myeloma, doubling both median progression-free survival (PFS) and overall response rate (ORR) versus pomalidomide and dexamethasone (Pd).
- Progression-free survival (primary endpoint, investigator-assessed): The combination reduced the risk of disease progression by 46%, demonstrating a median PFS of 10.25 months vs. 4.67 months for Pd alone after a minimum follow-up of 9.1 months.
- Overall response rate (secondary endpoint, investigator-assessed): Response rates doubled in patients receiving the combination (53.3%) compared with patients receiving Pd alone (26.3%), with very good partial responses or better seen in 20% of patients (n=12) and 8.8% of Pd-treated patients (n=5).