Dr. Berdeja Discusses Next Steps With bb2121 in Multiple Myeloma

Jesus Berdeja, MD
Published: Friday, Jan 26, 2018



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.


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.

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