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Bristol Myers Squibb Eyeing CLL, SLL as Additional Breyanzi Indications After Positive Readout

NEW YORK – Bristol Myers Squibb on Friday said it will discuss with regulatory authorities data from a Phase I/II trial showing that around 18 percent of patients with refractory chronic lymphocytic leukemia or small lymphocytic leukemia had a complete response to its CAR T-cell therapy Breyanzi (lisocabtagene maraleucel).

In the TRANSCEND CLL 004 trial, a prespecified primary efficacy analysis of a subset of 49 patients who had progressed on BTK and BCL2 inhibitors, 63.3 percent had undetectable minimal residual disease in the blood and 59.2 percent in the bone marrow after receiving Breyanzi. At a median follow-up of 21.1 months, the overall response rate was 42.9 percent and the median duration of response was 35.3 months for patients on the autologous cell therapy. None of the patients who achieved a complete response experienced disease progression or died, and the median duration of response in this subset was not reached.

BMS will present results from this study at the American Society of Clinical Oncology's annual meeting in June.

Breyanzi, a CD19-directed CAR T-cell therapy, is currently approved in the US as a treatment for large B-cell lymphoma including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal LBCL, and refractory follicular lymphoma. The latest data suggests BMS may be able to expand the use of the drug to other hematologic malignancies.

The company noted that there's a need for new treatments for refractory CLL or SLL patients. After progression on a BTK and a BCL2 inhibitor, CLL and SLL patients tend to have poor outcomes and do not respond well to currently available treatments.

"For people living with relapsed or refractory CLL or SLL after treatment with BTK inhibitors and BCL2 inhibitor-based regimens, there is no standard-of-care treatment," Tanya Siddiqi, lead investigator and associate professor in the division of lymphoma at City of Hope National Medical Center, said in a statement. "The durable complete responses observed with [Breyanzi] in the TRANSCEND CLL 004 trial are remarkable and represent a major step in bringing a personalized, T-cell based treatment approach delivered as a one-time infusion into clinical practice for a complex and historically incurable disease."