The U.S. Food and Drug Administration (FDA) today approved elotuzumab as part of an innovative immune-based therapy treatment for patients with relapsed multiple myeloma. This is the third myeloma drug approved by the FDA within the last month and the fourth new myeloma treatment approved within the last year. All four new agents were tested in clinical trials at Winship Cancer Institute of Emory University.
The phase III trial results of elotuzumab (trade name Empliciti), presented earlier this year and published in the New England Journal of Medicine by lead author Sagar Lonial, MD, chief medical officer of Winship, represents the largest study of a monoclonal antibody in multiple myeloma and the first phase III trial exploring a targeted immune-based approach to treating the disease. Winship also played a critical role in designing and leading the phase I and phase II trials of elotuzumab.
Lonial says the potential of elotuzumab can be seen in the overall response rate as well as the longer duration of progression-free survival. Patients in the study with recurrent multiple myeloma were randomly assigned to receive lenalidomide and dexamethasone (control group) or lenalidomide and dexamethasone with elotuzumab. At a median follow-up period of 24 months, elotuzumab reduced the risk of cancer progression and death by 30 percent. Patients in the elotuzumab group also experienced a significantly longer period without disease progression.
"It appears that, for patients with relapsed multiple myeloma who are offered lenalidomide and dexamethasone, addition of this new targeted drug makes the outcomes even better," said Lonial. "The difference between the elotuzumab and control groups seems to get bigger over time, which really speaks to the power of this immune based approach."
Elotuzumab attaches to a cell surface protein called SLAMF7, which is found on myeloma cells and on a type of immune cell known as natural killer (NK) cells. Scientists believe that elotuzumab mounts a two-pronged attack on cancer by targeting myeloma cells directly and by enhancing the NK cells' ability to kill myeloma cells.
Winship has played an important role in the clinical trials of all four myeloma treatments recently approved by the FDA. Winship was the first center worldwide to open the Phase II trial of daratumumab (trade name Darzalex) that led to the FDA's rapid review of this monoclonal antibody as a single agent for treating advanced stage multiple myeloma. Winship also conducted early trials of ixazomib (trade name Ninlaro), an oral proteasome inhibitor that works by blocking enzymes from multiple myeloma cells and hindering their ability to grow and survive; and panobinostat (Farydak), the first histone deacetylase (HDAC) inhibitor approved to treat multiple myeloma.
"The Winship multiple myeloma team has shepherded several of these treatments from the beginning stages of testing through to their approval," said Lonial. "It's a great source of pride to know we were instrumental in the process that has led to many more treatment options for our patients."
Video links: Dr. Sagar Lonial presented groundbreaking results from trials of both elotuzumab and daratumumab at the annual ASCO meeting earlier this year.