The TRANSCNED CLL 004 trial met its primary endpoint of complete responses with the CAR-T cell therapy Breyanzi in patients with relapsed or refractory CLL or SLL.
A phase 1/2 study assessing the CAR-T cell therapy Breyanzi (lisocabtagene maraleucel) met its primary endpoint of complete response rate — the disappearance of all signs of cancer from the treatment — in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
When a study meets its primary endpoint, that means that the main result measured at the end of the trial demonstrated that treatment with Breyanzi provided patients with relapsed or refractory CLL or SLL a complete response.
According to a press release from Bristol Myers Squibb, the manufacturer of Breyanzi, the TRANSCEND CLL 004 trial is comparing response from the drug with previously established data of patients with relapsed or refractory CLL that did not respond to a Bruton’s tyrosine kinase (BTK) inhibitor and who were pretreated with a B-cell lymphoma 2 (BCL-2) inhibitor. Of note, BTK and BCL-2 both play a role in B lymphocyte development, cancer cell survival and growth, among other processes, in patients with relapsed or refractory CLL or SLL.
“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,” said Anne Kerber, senior vice president and head of Cell Therapy Development at Bristol Myers Squibb, in the 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 SLL, with results showing the potential of Breyanzi as a personalized one-time treatment approach for patients with this difficult-to-treat disease.”
Treatment with Breyanzi was not associated with any new side effects in the trial, according to the release.
Researchers plan to conduct a full evaluation of data from the TRANSCEND CLL 004 study and present findings at an upcoming medical meeting, according to the release.
Breyanzi has previously been approved by the Food and Drug Administration for several other indications such as adults with high-grade B-cell lymphoma, large B-cell lymphoma and follicular lymphoma grade 3B that does not respond to first-line chemoimmunotherapy or relapsed within 12 months of treatment.
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