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.

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