Topline results were announced from the TRANSCEND CLL 004 trial investigating lisocabtagene maraleucel for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Lisocabtagene maraleucel is a CD19-directed genetically modified autologous T cell immunotherapy. It is currently approved under the brand name Breyanzi for adult patients with large B-cell lymphoma.
The phase 1/2, open-label, single-arm study (ClinicalTrials.gov Identifier: NCT03331198) met its primary endpoint of complete response rate, including complete remission with incomplete bone marrow recovery, compared with historical control in the prespecified subset of patients with relapsed/refractory CLL that was refractory to a Bruton tyrosine kinase inhibitor and pretreated with a BCL-2 inhibitor.
Commenting on the results, Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb, said: “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.”
No new safety signals were identified in the trial. Additional data is expected to be presented at an upcoming medical meeting.
Bristol Myers Squibb announces TRANSCEND CLL 004 trial of Breyanzi® (lisocabtagene maraleucel) met primary endpoint of complete response rate in patients with relapsed or refractory chronic lymphocytic leukemia. News release. January 26, 2023. https://www.businesswire.com/news/home/20230125005878/en/Bristol-Myers-Squibb-Announces-TRANSCEND-CLL-004-Trial-of-Breyanzi%C2%AE-lisocabtagene-maraleucel-Met-Primary-Endpoint-of-Complete-Response-Rate-in-Patients-with-Relapsed-or-Refractory-Chronic-Lymphocytic-Leukemia.