Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication • EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. • EMPLICITI is indicated 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. FDA label
Also known as HuLuc63
Elotuzumab · 1 trial · 1 indication
MTD was determined by testing increasing doses up to 20 mg/kg once daily dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (dose limiting toxicity \[DLT\]) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria for Adverse Events (CTCAE) Grade 4 neutropenia in specific conditions, platelets \< 10,000 cells/mm\^3 that do not recover to 25,000 cells/mm\^3; and specific non-hematologic/biochemical toxicities CTCAE Grade 3 or 4 (except fatigue and Grade 3 infections); CTCAE version 3.0 were used.
ORR: Percentage of participants with confirmed complete response (CR; negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow), partial response (PR; ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to ≤200 mg per 24 hour; if serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC\] levels is required in place of the M-protein criteria; if serum and urine M-protein are unmeasurable, and serum FLC is also unmeasurable, a ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%; and, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas), very good PR (VGPR; normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence), or stringent CR (sCR; CR plus VGPR).
| Arm | Type | Description |
|---|---|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | EXPERIMENTAL | Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | EXPERIMENTAL | Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | EXPERIMENTAL | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | EXPERIMENTAL | Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | EXPERIMENTAL | Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally. |
| Name | Type | Description |
|---|---|---|
| elotuzumab | BIOLOGICAL | Humanized Anti-CS1 Monoclonal IgG1 Antibody (HuLuc63) administered as an intravenous infusion once a week during Cycles 1 and 2, and every other week beginning with Cycle 3. |
| lenalidomide | DRUG | Lenalidomide 25 mg administered orally once daily on Days 1 to 21 of each 28-day cycle |
| dexamethasone oral | DRUG | Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously) |
| dexamethasone injection | DRUG | Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously) |
Inclusion Criteria: 1. Age 18 years or older with a confirmed diagnosis of multiple myeloma (MM) and documentation of one to three prior therapies. 2. Confirmed evidence of disease progression from immediately prior MM therapy or refractory to the immediately prior treatment. 3. Measurable monoclon...
Elotuzumab is a monoclonal antibody being studied for hematologic cancer, specifically relapsed multiple myeloma. It is an investigational therapy in Phase 2 development. The clinical program has evaluated it in patients with this blood cancer, and it is not yet approved for commercial use.
Elotuzumab targets SLAMF7, also known as CS1, a cell surface protein. It is a humanized monoclonal IgG1 antibody that binds SLAMF7. The target class is an inhibitor. By binding SLAMF7, elotuzumab is designed to act against myeloma cells that express this protein.
Elotuzumab is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program for this monoclonal antibody in hematologic cancer.
Elotuzumab is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 2 program has been conducted in patients with relapsed multiple myeloma, a type of hematologic cancer.
Elotuzumab has been studied in the completed Phase 1b/2 trial NCT00742560, titled a dose-escalation study in relapsed multiple myeloma. This trial enrolled 101 patients aged 18 years and older and used a controlled design. No active trials are currently listed for elotuzumab.