Dr. Berdeja Discusses Next Steps With bb2121 in Multiple Myeloma
Jesus Berdeja, MD
Jesus Berdeja, MD, director of Multiple Myeloma Research, Sarah Cannon Research Institute, discusses next steps with the chimeric antigen receptor (CAR) T-cell therapy bb2121 in multiple myeloma.
The second-generation BCMA-targeted CAR T-cell therapy bb2121 was granted a breakthrough therapy designation by the FDA in November 2017, based on the preliminary clinical data from the phase I CRB-401 study.
In a study of patients with relapsed/refractory multiple myeloma presented at the 2017 ASH Annual Meeting, bb2121 induced complete remissions in 56% of patients. The treatment was generally well tolerated, with an objective response rate of 94%, and a partial response or better for 89% of patients. After 40-weeks of follow-up, median progression-free survival (PFS) has not yet been reached, but the 9-month PFS rate was 71%.
Berdeja says that an expansion phase of this trial is in the process of enrolling. There are already plans to move the cells earlier, and there will be a randomized trial in the third-line setting that is already being planned. There may be potential for bb2121 in the frontline setting for a subset of patients.