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.

Empliciti is supplied as a solution for intravenous administration. 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.

Clinical Results

FDA Approval

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.

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).