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May 27, 2022

BMS’ Breyanzi offers durable response in Phase II lymphoma trial

Breyanzi had a manageable safety profile without any new safety signals reported.

Bristol-Myers Squibb (BMS) has reported initial assessment results from Phase II PILOT clinical trial, where its Breyanzi (lisocabtagene maraleucel) offered substantial durable responses in adults with refractory or relapsed large B-cell lymphoma (r/r LBCL).

Breyanzi is a CD-19 directed chimeric antigen receptor (CAR) T cell therapy.

The multicentre trial analysed Breyanzi as a second-line therapy in adult patients with r/r LBCL following first-line therapy who were not eligible to receive high-dose chemotherapy and hematopoietic stem cell transplant (HSCT).

Overall response rate was the trial’s primary endpoint.

Complete response rate, progression-free survival (PFS), event-free survival, duration of response and overall survival (OS) were included as the other efficacy endpoints.

According to the findings, most of the subjects who received Breyanzi showed a decline in disease at a median follow-up of 12.3 months.

In the trial, 80% of subjects were found to respond to the treatment, while 54% of the participants attained complete response (CR).

At 15.5 months median follow-up, responses with Breyanzi were reported to be durable with 12.1 months of median duration of response.

In subjects who attained a CR, the median duration of response was found to be 21.7 months.

Median PFS following Breyanzi treatment was nine months and median OS has not been achieved.

Furthermore, Breyanzi had a manageable safety profile without any new safety signals reported.

An assessment of patient-reported outcomes (PRO) from the trial showed that subjects treated with Breyanzi had substantial improvements in fatigue and pain.

In addition, 70% of subjects had meaningful improvements in quality of life at month six in an individual subject-level assessment.

Bristol Myers Squibb Cell Therapy Development senior vice-president Anne Kerber said: “With Breyanzi, we have boldly designed a broad clinical trial programme in relapsed or refractory LBCL, including patients who are not intended for stem cell transplant after failure of first-line therapy.

“These results from the PILOT study continue to demonstrate the practice-changing potential of Breyanzi in this setting, delivering on the promise of CAR T cell therapy for more patients.”

In February this year, the US Food and Drug Administration granted priority review of the company’s supplemental Biologics License Application for Breyanzi to treat adult r/r LBCL patients.

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.

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