Drug (Brand / Generic)
Empliciti / elotuzumab
Company / Licensee
Bristol-Myers Squibb (BMS) / AbbVie
Approved in the US, Europe
Empliciti (elotuzumab) is an immunostimulatory antibody indicated for the treatment of multiple myeloma.
The drug was developed by Bristol-Myers Squibb (BMS) in collaboration with AbbVie.
BMS received approval for Empliciti from US Food and Drug Administration (FDA) for the treatment of multiple myeloma in November 2015, making it the first and only FDA approved immunostimulatory antibody drug.
It was approved to be used as combination therapy with Revlimid (lenalidomide) and dexamethasone (ERd) in multiple myeloma patients who received one to three therapies before.
The drug was granted breakthrough therapy designation by the FDA in May 2014.
The marketing authorisation application (MAA) for Empliciti for the treatment of multiple myeloma was validated for review by the European Medicines Agency (EMA) in July 2015.
In addition, the drug was granted accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of EMA.
Multiple myeloma is a type of blood cancer that originates in the bone marrow. It is characterised by the accumulation of cancerous white blood cells in the bone marrow. Symptoms include bone pain, fatigue, kidney impairment and infections.
It is estimated that more than 750,000 people worldwide are living with multiple myeloma. It is also estimated that 24,050 new cases of multiple myeloma were diagnosed and more than 11,000 people died from this type of blood cancer in the US in 2014.
Empliciti’s mechanism of action
Empliciti contains an immunostimulatory antibody that targets the Signalling Lymphocytic Activation Molecule family member 7 (SLAMF7) glycoprotein.
It also targets SLAMF7 on myeloma cells and facilitates the interaction with natural killer cells to mediate the killing of myeloma cells through antibody dependent cellular cytotoxicity (ADCC).
The drug is available for intravenous administration in 300mg and 400mg vials.
Clinical trials on elotuzumab
FDA approval for Empliciti was based on results from a Phase III clinical trial known as ELOQUENT-2 (CA204-004). It was a randomised, open-label clinical study that evaluated Empliciti in combination with lenalidomide and dexamethasone (ERd) versus lenalidomide and dexamethasone (Rd) alone.
The study enrolled 646 relapsed or refractory multiple myeloma patients that received one to three prior therapies.
Patients were randomised in 1:1 ratio to receive either Empliciti 10mg/kg in combination with Rd (ERd) or Rd alone in four-week cycles until disease progression or unacceptable toxicity.
Co-primary endpoints of the study included progression-free survival (PFS), which was assessed by ratio, and overall response rate (ORR) as determined by a blinded Independent Review Committee using the European Group for Blood and Marrow Transplantation response criteria.
Results of the study demonstrated that patients treated with ERd witnessed a 30% reduction in the risk of disease progression or death compared to those treated with Rd alone.
The PFS rates in the ERd arm were 68% versus 57% in the Rd arm after one year, while the PFS rates in ERd and Rd arms were 41% versus 27% respectively after two years.
Patients treated with the ERd regimen showed a significant improvement by achieving an ORR of 78.5% compared to 65.5% in the Rd arm. The median PFS in the ERd group was 19.4 months compared to 14.9 months in the Rd group.
The most frequent serious adverse reactions found in the ERd arm during the clinical study were pneumonia, pyrexia, respiratory tract infection, anaemia, pulmonary embolism, and acute renal failure.
The commercialisation of Empliciti is the sole responsibility of Bristol-Myers Squibb (BMS).
Other medications available in the market for the treatment of multiple myeloma are Ninlaro (ixazomib) developed by Takeda Pharmaceuticals, and Farydak (panobinostat) manufactured by Novartis and Biologics.