The TRANSCEND CLL 004 trial evaluated the CAR T cell therapy in patients with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma
A Bristol Myers Squibb R&D facility in Lawrence, New Jersey. (Credit: Coolcaesar at English Wikipedia from Wikimedia Commons)
Bristol Myers Squibb announced that its cancer therapy Breyanzi (lisocabtagene maraleucel) met the primary endpoint of complete response rate in the TRANSCEND CLL 004 phase 1/2 trial in adult patients with relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
The single-arm clinical trial compared Breyanzi with historical control in a prespecified subset of patients with R/R CLL which was refractory to a BTK inhibitor and subject to prior treatment with a BCL-2 inhibitor.
Breyanzi is a CD19-directed CAR T cell therapy, which has been approved by the US Food and Drug Administration (FDA) for the treatment of large B-cell lymphoma (LBCL) in adults.
Bristol Myers Squibb cell therapy development head Anne Kerber said: “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.
“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 pre-treated 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.”
Phase 1 of the TRANSCEND CLL 004 open-label study is for assessing the recommended dose and safety of the CAR T cell therapy for the ensuing phase 2 expansion cohort.
Breyanzi is being tested in phase 2 of the study at the dose that was prescribed for the phase 1 monotherapy group, the US-based pharmaceutical firm added.
According to an independent review committee, the primary endpoint of phase 2 of the study was the complete response rate, which included full remission with incomplete bone marrow recovery.
Breyanzi is also approved for the treatment of relapsed and refractory LBCL following two or more lines of systemic therapy in Europe, Switzerland, Canada, and Japan.
Bristol Myers Squibb anticipates releasing detailed reports on the findings of the TRANSCEND CLL 004 at an upcoming medical meeting.