What is elotuzumab (Empliciti®)?
Elotuzumab is a monoclonal antibody. It was approved for use in combination with lenalidomide (an immunomodulatory drug) and dexamethasone (an anti-inflammatory medicine). Elotuzumab was approved by the EMA in 2016 for the treatment of adult patients with myeloma who have received at least one prior therapy.
How does elotuzumab work?
Elotuzumab is an immunostimulatory antibody (a protein that is produced by the immune system to help stop intruders from harming the body) that specifically targets the SLAMF7 protein (also known as CS1). This protein is expressed on the surface of myeloma cells and natural killer cells. Elotuzumab has a dual mechanism of action. By binding to the SLAMF7 protein on natural killer cells, this drug activates the immune system. It also targets SLAMF7 on myeloma cells, which tags them for recognition by natural killer cells. When a natural killer cell activated by elotuzamab recognises a myeloma cell tagged by this drug, cell death occurs.
What are the benefits of elotuzumab?
A clinical trial, involving 646 patients, studied the combination of elotuzumab, lenalidomide, and low-dose dexamethasone as compared to lenalidomide and dexamethasone alone in patients who had received one to three prior therapies and had progressed following their most recent therapy. Patients who took a combination of treatment (elotuzumab, lenalidomide, and low-dose dexamethasone) had a 30% reduction of risk of disease progression or death compared to patients who took only lenalidomide and dexamethasone. Patients receiving a combination treatment lived without their disease worsening for an average of 4.5 months longer than patients taking lenalidomide and dexamethasone alone (19.4 months vs. 14.9 months). These observed benefits were maintained over time. In addition, a higher percentage of patients taking a combination treatment achieved a partial response or better as compared to those taking lenalidomide and dexamethasone alone (overall response rate of 79% vs. 66%).
How and when is elotuzumab given?
Elotuzumab is given as an intravenous (IV) infusion into a vein. The dose is 10 mg/kg of body weight. It is given along with oral lenalidomide and dexamethasone once a week for the first two cycles and every two weeks after that time. Elotuzumab is given until the disease progresses or there is unacceptable toxicity.
Patients are required to take the following oral medications to reduce the risk of infusion reaction before receiving elotuzumab:
- antihistamines, (e.g. diphenhydramine and ranitidine)
- a fever-reducing agent (e.g acetaminophen)
What are the side effects?
In the same clinical study (ELOQUENT-2), the most serious adverse reactions in patients taking elotuzumab in combination with lenalidomide and low-dose dexamethasone as compared to those taking lenalidomide and low-dose dexamethasone alone were: pneumonia (15.4% vs. 11%), pyrexia (6.9% vs. 4.7%), respiratory tract infection (3.1% vs. 1.3%), anaemia (2.8% vs. 1.9%), pulmonary embolism (3.1% vs. 2.5%), and acute renal failure (2.5% vs. 1.9%).
The common side effects seen with elotuzumab in combination with lenalidomide and low-dose dexamethasone included:
- numbness, weakness, tingling, or burning pain in the arms or legs
- sore throat or runny nose
- upper respiratory tract infection
- decreased appetite
Patients should contact their healthcare provider if they experience signs and symptoms of infusion reactions including fever, chills, rash or breathing problems within 24 hours of infusion.
- The Multiple Myeloma Research Foundation (MMRF). https://www.themmrf.org/multiple-myeloma-knowledge-center/myeloma-drugs-guide/empliciti-elotuzumab/
- Food and Drug Administration. Approved Drugs. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm474719.htm
- Manufacturer’s product information http://www.empliciti.com/ and http://packageinserts.bms.com/pi/pi_empliciti.pdf
- European Medicines Agency. Empliciti (elotuzumab) European public assessment report (EPAR) – last updated 05/2016