Bristol Myers Squibb has reported topline results from the Phase I/II TRANSCEND CLL 004 trial of Breyanzi (lisocabtagene maraleucel) in relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) adults.
The open-label, single-arm, multicentre trial has been designed for assessing the CD19-directed CAR T cell therapy in these patients.
The trial’s Phase I dose escalation section evaluated Breyanzi’s safety and recommended dose for the subsequent Phase II expansion cohort.
Bristol Myers Squibb noted that the Phase II portion is evaluating Breyanzi at the recommended dose from the Phase I monotherapy arm.
Complete response rate, including complete remission with incomplete bone marrow recovery, was the primary endpoint of the trial’s Phase II part.
Data from the TRANSCEND CLL 004 trial showed that the study met the primary endpoint of complete response rate, compared to historical control in the prespecified patient subset with R/R CLL.
In this trial, no new safety signals were reported for Breyanzi.
Bristol Myers Squibb Cell Therapy Development senior vice-president, 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 personalised one-time treatment approach for patients with this difficult-to-treat disease.”
Bristol Myers Squibb plans to complete a full evaluation of the results obtained from the TRANSCEND CLL 004 clinical trial.
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