EMPLICITI™ (elotuzumab) is a first-of-its-kind immunotherapy medicine that directly activates a key type of white blood cell in your immune system—called a Natural Killer (NK) Cell—to fight multiple myeloma. EMPLICITI also identifies myeloma cells so they are more easily recognized by NK Cells. That way, activated NK Cells can find myeloma cells to destroy.
EMPLICITI is a prescription medicine used to treat multiple myeloma in combination with the medicines REVLIMID® (lenalidomide) and dexamethasone in people who have received one to three prior treatments for their multiple myeloma. EMPLICITI is for adults. The safety and effectiveness of EMPLICITI has not been studied in children. Talk to your healthcare provider to learn more.
To learn more about how EMPLICITI works, click here.
How many people were in the study?
What was the main goal of the study?
The study was designed to look at progression-free survival at 2 years. Progression-free survival is the length of time during and after treatment of a disease that a patient lives with the disease but it does not get worse.
The study was also designed to look at the overall response rate. Overall response rate is the percentage of patients who responded to treatment—for example, patients whose level of M protein was lowered by a certain amount. Overall response rates include complete response, very good partial response, and partial response.
The main analysis for progression-free survival took place at 2 years. Patients still benefiting from treatment continued in the study, and a follow-up analysis was done at 5 years. Both evaluations were based on the entire population of 646 patients.
What were the results of the study?
EMPLICITI in combination with REVLIMID and dexamethasone showed:
AT 5 YEARS, MORE PEOPLE TAKING EMPLICITI WERE LIVING WITH THEIR DISEASE UNDER CONTROL
- At 2 years, there was an 41% chance that people taking EMPLICITI with REVLIMID and dexamethasone were living with their disease under control, compared with a 27% chance for people taking REVLIMID and dexamethasone alone.
- At the 5-year follow-up, there was a 18% chance that people taking EMPLICITI with REVLIMID and dexamethasone were still living with their disease under control, compared with a 12% chance for people taking REVLIMID and dexamethasone alone.
30% LESS RISK OF DISEASE PROGRESSION
- After at least 2 years of follow-up, people who received EMPLICITI with REVLIMID and dexamethasone were at 30% less risk of their disease progressing or passing away from any cause, compared with people taking REVLIMID and dexamethasone alone. After at least 5 years of follow-up, results were similar.
~4 OUT OF 5 PEOPLE RESPONDED TO TREATMENT
- About 4 out of 5 people (78.5%) responded to treatment with EMPLICITI with REVLIMID and dexamethasone compared to about 2 out of 3 people (65.5%) taking REVLIMID and dexamethasone alone.
Selected Important Facts About EMPLICITI
What are the most common side effects of EMPLICITI?
- numbness, weakness, tingling, or burning pain in your arms or legs
- sore throat or runny nose
- upper respiratory tract infection
- decreased appetite
These are not all of the possible side effects of EMPLICITI.
Call your doctor for medical advice about side effects.
You can report any side effects you experience to the FDA by calling 1-800-FDA-1088.
Please read other Important Facts below.