Breyanzi study meets complete response endpoint for leukemia, lymphoma subgroup
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A phase 1/phase 2 trial of lisocabtagene maraleucel for adults with advanced chronic lymphocytic leukemia or small lymphocytic lymphoma met its primary endpoint, according to the agent’s manufacturer.
Lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb) — a CD19-directed chimeric antigen receptor T-cell therapy — is approved for treatment of adults with relapsed or refractory large B-cell lymphoma who received two or more lines of systemic therapy, as well as those refractory to first-line chemoimmunotherapy or who relapsed within 12 months of first-line chemoimmunotherapy.
The multicenter TRANSCEND CLL 004 study is evaluating the efficacy and safety of the therapy for adults with relapsed or refractory CLL or small lymphocytic leukemia.
Complete response rate — including complete remission with incomplete bone marrow recovery — among those who previously received a BCL-2 inhibitor and also were refractory to a Bruton tyrosine kinase inhibitor served as the primary endpoint for the phase 2 portion of the trial.
The trial met the endpoint, showing improvement in complete response rate with lisocabtagene maraleucel compared with historical controls.
“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, MD, senior vice president and head of cell therapy development at Bristol Myers Squibb, said in a company-issued press release. “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 [small lymphocytic lymphoma], with results showing the potential of Breyanzi as a personalized one-time treatment approach for patients with this difficult-to-treat disease.”
Researchers reported no new safety issues with the use of lisocabtagene maraleucel during the study.
Complete results from the study will be presented at a medical meeting, according to the press release.