Empliciti

Multiple myeloma — in combination with lenalidomide and dexamethasone, in patients who have received one to three prior therapies; in combination with pomalidomide and dexamethasone, in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor

With lenalidomide + dex (28-day cycle): 10 mg/kg IV on Days 1, 8, 15, 22 for Cycles 1-2; then Days 1, 15 for Cycle 3+
With pomalidomide + dex (28-day cycle): 10 mg/kg IV on Days 1, 8, 15, 22 for Cycles 1-2; then 20 mg/kg Day 1 for Cycle 3+
Infusion rate: 0.5 mL/min for first 30 min, escalate to max 5 mL/min
Pre-medication (45-90 min prior): Dexamethasone 28 mg PO + 8 mg IV, acetaminophen 650-1000 mg, diphenhydramine 25-50 mg (or equivalent), ranitidine 50 mg IV or equivalent

For injection: 300 mg, 400 mg lyophilized powder in single-dose vials

None listed.

• Infusion Reactions: 10% (3.6% Grade 3). Pre-medicate. Interrupt for Grade ≥2, resume at 0.5 mL/min upon resolution ≤Grade 1. Permanently discontinue for severe reactions.
• Infections: 81% (Grade ≥3: 28%). Including pneumonia, herpes zoster. Consider antiviral prophylaxis.
• Secondary Primary Malignancies (SPM): 9% incidence.
• Hepatotoxicity: Including fatal cases. Monitor LFTs periodically. Withhold for Grade ≥3 hepatotoxicity.
• Interference with Myeloma Response Assessment: Elotuzumab is an IgG kappa monoclonal antibody detectable on serum protein electrophoresis (SPEP) and immunofixation (IFE).

Fatigue (62%), diarrhea (47%), pyrexia (37%), constipation (36%), cough (34%), nausea (29%), pneumonia (20%), upper respiratory tract infection (23%), decreased appetite (21%), nasopharyngitis (17%), infusion reactions (10%)

Infusion reactions in 10% (Grade 3 in 1%). Pre-medicate with dexamethasone, H1-blocker, H2-blocker, acetaminophen. Grade 3-4 infections in 28%.

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

Infusion reactions in 10% (Grade 3 in 1%). Pre-medicate with dexamethasone, H1-blocker, H2-blocker, acetaminophen. Grade 3-4 infections in 28%.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Elotuzumab is a humanized IgG1 monoclonal antibody targeting SLAMF7 (Signaling Lymphocytic Activation Molecule Family member 7, also known as CS1 or CD319). SLAMF7 is highly expressed on myeloma cells and natural killer (NK) cells. Elotuzumab has a dual mechanism: it directly activates NK cells through SLAMF7-mediated signaling (enhancing cytotoxicity), and it facilitates the interaction between NK cells and myeloma cells to mediate killing through ADCC.

Half-life: mean ~82 hours. Linear PK from 10-20 mg/kg. Steady-state reached by Cycle 3 with weekly dosing. Clearance: 15.6 mL/day. Vd: 5.7 L.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• ELOQUENT-2 — Elotuzumab + lenalidomide/dex vs. lenalidomide/dex in relapsed/refractory MM. Phase III, n=646.
  🔬 NCT01239797 ↗ 📄 Primary Publication ↗

Empliciti has FDA-approved indications across the following cancer types covered on PipelineEvidence: