Empliciti

What is Empliciti?

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

The Multiple Myeloma Research Consortium (MMRC) played a role in the development of this drug and is currently facilitating several trials evaluating its use in combination with other myeloma agents.

Read the Press Release


How is Empliciti used?

Currently, Empliciti is used to treat multiple myeloma in the following ways:

  • Combined with Revlimid (lenalidomide, Celgene) and dexamethasone to treat patients who have received one to three prior therapies
  • Combined with Pomalyst (pomalidomide, Celgene) and dexamethasone to treat patients who have received at least two prior therapies, including Revlimid and a proteasome inhibitor

What 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 in combination with Revlimid and dexamethasone

In this combination, Empliciti is given as an intravenous (IV) infusion at a dose of 10 mg/kg of body weight. Empliciti is given along with Revlimid (an oral pill) and dexamethasone (either as an oral pill or an IV infusion) once a week for the first two cycles and every 2 weeks thereafter.

Empliciti is given until the multiple myeloma progresses or until the patient experiences unacceptable adverse reactions.

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

Empliciti in combination with Pomalyst and dexamethasone

In this combination, Empliciti is given as an IV infusion at a dose of 10 mg/kg every week for the first two cycles. Starting with the third cycle, the infusions are given every 4 weeks and the dose is increased to 20 mg/kg. Empliciti is given along with Pomalyst (and oral pill) and dexamethasone (either as an oral pill or an IV infusion) until the disease progresses or until unacceptable adverse reactions occur. When administered orally, the dexamethasone dose varies with patients ≤75 years old (40 mg) and those > 75 years old (20 mg).


What are Empliciti side effects?

In the clinical study that led to the approval of Empliciti, the most common side effects seen with Empliciti in combination with Revlimid  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
  • Low heart rate

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 given Empliciti treatment are monitored for infections and treated as necessary.

The most common side effects seen with Empliciti in combination with Pomalyst and dexamethasone included constipation and hyperglycemia.

How are side effects of Empliciti managed?

For patients who experience a moderate or severe infusion reaction after receiving Empliciti, the infusion is stopped and their symptoms are 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?

Empliciti can be detected in tests used to monitor M protein levels; thus treatment with Empliciti may affect the ability to assess treatment response and disease progression in patients with some forms of myeloma.


What have Empliciti clinical trials shown?

The safety and efficacy of Empliciti  has been demonstrated in several clinical trials in patients with relapsed and/or refractory multiple myeloma.

In a study (ELOQUENT-2) comparing the combination of Empliciti,  Revlimid, and low-dose dexamethasone to Revlimid and low-dose dexamethasone alone (a regimen referred to as Rd) in patients who had received one to three prior therapies and had progressed following their most recent therapy, the following findings were reported:

  • 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%).
  • 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.

Clinical trials facilitated by the Multiple Myeloma Research Consortium (MMRC) reported the following findings:

  • Empliciti plus Rd in patients who had received an average of three prior therapies reported an overall response rate of 84%
  • The 10 mg/kg dose of Empliciti was more effective than a 20 mg/kg dose.

A study (ELOQUENT-3) comparing the combination of Empliciti, Pomalyst, and low-dose dexamethasone to Pomalyst and low-dose dexamethasone alone (a regimen known as Pd) in patients who had received at least two prior therapies (which must have included Revlimid and a proteasome inhibitor alone or in combination) and had progressed following their most recent therapy reported the following findings:

  • The addition of Empliciti to Pd resulted in a 46% reduction in risk of disease progression or death compared to Pd alone.
  • On average, the time that patients receiving Empliciti-Pd lived without their disease worsening was 10.3 months compared with 4.7 months with Pd.
  • A significantly higher percentage of patients taking Empliciti with Pd achieved a partial response or better compared to those only taking Pd (overall response rate of 53% vs 26%).

How is Empliciti currently being studied in myeloma?

In addition to the ELOQUENT-2 (NCT01239797) and ELOQUENT-3 (NCT02654132) trials, a third phase 3 trial (ELOQUENT-1; NCT01335399) 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 (ELO 1 Substudy; NCT01891643) will determine if patients receiving added Empliciti have lower levels of the SLAMF7/CS1 marker on their myeloma cells at the time of disease progression. Both trials are fully enrolled.

CheckMate 602 (NCT02726581) is an ongoing phase 3 study comparing three treatment arms:

  • Nivolumab, pomalidomide, and dexamethasone
  • Nivolumab, Empliciti, and pomalidomide
  • Pomalidomide and dexamethasone.

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 Nurse Patient Navigator to learn more or use our clinical trials finder:

FIND CLINICAL TRIALS

Updated February 2019

Please visit the sponsor’s official patient site for up-to-date information on Empliciti