Bristol Myers Squibb’s Breyanzi has received US FDA approval for adults with R/R FL and MCL. Credit: JHVEPhoto / Shutterstock.

US-based pharmaceutical company Bristol Myers Squibb (BMS) has published data from three studies in which Breyanzi (lisocabtagene maraleucel; liso-cel) caused clinically meaningful outcomes in a wide range of B-cell malignancies.

The findings include results from the Phase III TRANSFORM trial of Breyanzi as a second-line treatment for relapsed or refractory (R/R) large B-cell lymphoma (LBCL), as well as subgroup analysis data of Breyanzi in the mantle cell lymphoma (MCL) cohort of the TRANSCEND NHL 001 trial.

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According to data from the Phase III TRANSFORM study, Breyanzi showed significant clinical benefit in patients with primary refractory LBCL or relapsed disease within 12 months after first-line therapy.

With a median follow-up of 33.9 months, improvements were seen in event-free survival (EFS), progression-free survival (PFS), overall responses and duration of response (DOR) compared to the standard of care.

In the MCL cohort of the TRANSCEND NHL 001 trial, Breyanzi demonstrated similar efficacy across most subgroups, including heavily pre-treated patients.

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    The greatest benefit was observed in patients who had received two to four prior lines of therapy.

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    Breyanzi has obtained accelerated approval from the US Food and Drug Administration for adults with R/R FL and MCL who have undergone at least two prior lines of systemic therapy.

    BMS late clinical development, haematology, oncology and cell therapy head and senior vice-president Anne Kerber said: “This year’s ASCO is another exciting moment in the cascade of milestones for Breyanzi, our differentiated CAR T-cell therapy approved for the broadest range of B-cell malignancies of any CAR T-cell therapy.

    “The new data being presented from our vast clinical development programme are an incredible showcase of the improved outcomes and consistent safety profile Breyanzi provides for patients with diverse types of lymphomas, offering a definitive therapy with demonstrated improved outcomes, and we remain dedicated to leading the advancement of innovative therapies to improve outcomes for a wide range of patients.”