Empliciti™

What is Empliciti?

Empliciti™, also known as elotuzumab, is a monoclonal antibody approved for use in multiple myeloma. Empliciti is made by Bristol-Myers Squibb and AbbVie.

The Multiple Myeloma Research Consortium (MMRC) has played a role in this drug’s development and is currently facilitating several trials evaluating Empliciti in combination with other myeloma agents.

Read the Press Release


How is Empliciti used?

Empliciti™ (elotuzumab, Bristol-Myers Squibb/AbbVie) is a monoclonal antibody. It is approved for use in combination with Revlimid® (lenalidomide, Celgene) and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.

What types of patients may benefit from Empliciti?

In clinical trials, Empliciti in combination with Revlimid and dexamethasone was shown to be effective in:

  • Both younger and older patients
  • Patients who have received one to three prior therapies
  • Patients who have received more than three prior therapies (heavily pretreated)
  • Patients who previously received high-dose chemotherapy and stem cell transplant
  • Patients with high-risk genetic features
  • Patients with reduced kidney function (renal impairment)

How does Empliciti work?

Empliciti binds to the SLAMF7 protein, also known as CS1, expressed on myeloma cells. Empliciti directly activates immune cells known as Natural Killer (NK) cells and, by binding to SLAMF7, facilitates NK-mediated killing of myeloma cells.


How is Empliciti administered?

Empliciti™ (elotuzumab, Bristol-Myers Squibb/AbbVie) is given as an intravenous (IV) infusion into a vein at a dose of 10 mg/kg of body weight. It is given along with Revlimid®(lenalidomide, Celgene) and dexamethasone once a week for the first two cycles and every 2 weeks thereafter.

Empliciti is given until disease progression or there is unacceptable toxicity.

Before receiving Empliciti, patients receive premedication with dexamethasone, antihistamines, and a fever-reducing agent (acetaminophen) to reduce the risk of infusion reactions, which can occur following administration of Empliciti.


 

What are Empliciti side effects?

In the clinical study that led to the approval of Empliciti™ (elotuzumab, Bristol-Myers Squibb/AbbVie), the most common side effects seen with Empliciti in combination with Revlimid® (lenalidomide, Celgene) and dexamethasone included:

  • Fatigue
  • Diarrhea
  • Fever
  • Constipation
  • Respiratory effects (cough, Infection of the nose and throat [nasopharyngitis], upper respiratory tract infection, or pneumonia)
  • Peripheral neuropathy
  • Decreased appetite

The most common serious side effects included:

  • Low white blood cell counts
  • Low platelet counts
  • Increased blood sugar
  • Pneumonia
  • Fatigue
  • Low blood calcium

In this study, some patients experienced infusion reactions. The most common symptoms were fever, chills, and high blood pressure.

Some patients developed infections while receiving this drug combination. All patients receiving Empliciti will be monitored for development of infections and treated as necessary.

How are side effects of Empliciti managed?

Patients who experience a moderate or severe infusion reaction will have their Empliciti infusion stopped and their symptoms treated. After symptoms resolve, the infusion may be resumed at a slower rate. Empliciti may be discontinued in patients who experience severe infusion reactions.

Can Empliciti affect laboratory testing?

As Empliciti is an IgG monoclonal antibody, it can be detected on tests used for the clinical monitoring of M protein and may impact the determination of complete response and of disease progression in some patients with IgG myeloma.


What have Empliciti clinical trials shown?

The safety and efficacy of Empliciti™ (elotuzumab, Bristol-Myers Squibb/AbbVie) has been demonstrated in several clinical trials in patients with relapsed and/or refractory multiple myeloma.

The combination of Empliciti plus Revlimid® (lenalidomide, Celgene) and low-dose dexamethasone (Revlimid-low-dose dex, or Rd) was compared to Rd alone in a Phase III trial known as ELOQUENT-2, which supported the approval of Empliciti. This trial included 646 patients who had received one to three prior therapies and had progressed following their most recent therapy.

  • The addition of Empliciti to Rd resulted in a 30% reduction in risk of disease progression or death compared to Rd alone.
  • On average, the time that patients receiving Empliciti-Rd lived without their disease worsening was 19.4 months compared with 14.9 months with Rd.
  • This significant progression-free survival benefit with Empliciti-Rd was maintained over time, with higher rates compared with Rd at one year (68% vs. 57%), two years (41% vs. 27%), and three years (26% vs. 18%).
  • In addition, a significantly higher percentage of patients taking Empliciti with Rd achieved a partial response or better compared to those only taking Rd (overall response rate of 79% vs. 66%).
  • Based on these results, Empliciti-Rd is listed as one of several preferred regimens for previously treated myeloma in recent treatment guidelines.

Empliciti has also been evaluated as part of combination therapy in Phase II clinical trials that were facilitated by the Multiple Myeloma Research Consortium (MMRC).

  • For example, a trial of Empliciti plus Revlimid-dex in 73 patients who had received an average of three prior therapies reported an overall response rate of 84% and found that the 10 mg/kg dose of Empliciti was more effective than a 20 mg/kg dose.

How is Empliciti currently being studied in myeloma?

In addition to the ELOQUENT-2 trial, a second Phase III trial (ELOQUENT-1) is evaluating whether adding Empliciti to Rd as treatment for newly diagnosed myeloma will increase the length of time before the disease progresses. A substudy will determine if patients receiving added Empliciti have lower levels of the SLAMF7/CS1 marker on their myeloma cells at time of disease progression. Both trials are fully enrolled.

Additional trials are being conducted in a variety of settings, including newly diagnosed myeloma, relapsed/refractory disease, and smoldering multiple myeloma., and use as maintenance therapy following stem cell transplant.

Interested in learning more about Empliciti clinical trials? Talk to an MMRF Patient Support Nurse to learn more or use our clinical trials finder:

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