Skip to main content
Premium Trial:

Request an Annual Quote

BMS Eyeing Breyanzi Indications in CLL, SLL After Positive Trial Data

NEW YORK – Bristol Myers Squibb on Thursday said it will discuss with regulators positive data from a Phase I/II study of its CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) in chronic lymphocytic leukemia or small lymphocytic lymphoma.

The TRANSCEND CLL 004 trial met its primary endpoint and showed that Breyanzi-treated patients had higher complete response rates compared to historical control. To partake in the trial, patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma had to have relapsed on a BTK inhibitor and received a BCL-2 inhibitor.

After fully analyzing the data from the trial, BMS will discuss Breyanzi's activity in this setting with health authorities and present the findings at a future medical meeting.

"CLL is an incurable disease with complex biology and immune dysregulation that has made the development of T-cell-based therapies that provide deep remission very challenging," Anne Kerber, head of cell therapy development at BMS, said in a statement. "In a population that has limited options, the TRANSCEND CLL 004 study represents the first multicenter trial evaluating a CAR T-cell therapy in heavily pretreated patients with relapsed or refractory CLL or SLL, with results showing the potential of Breyanzi as a personalized one-time treatment approach for patients with this difficult-to-treat disease."

Last year, BMS published preliminary data from the TRANSCEND CLL 004 trial from 22 evaluable patients in the dose-escalation portion of the study and reported an 82 percent response rate and 45 percent complete response rate on Breyanzi.

Breyanzi is approved in the US for second- and third-line treatment of relapsed or refractory large B-cell lymphoma and in Europe as a third-line treatment.