Bristol Myers Squibb Unveils Initial Data on Marginal Zone Lymphoma from Transcend FL Trial Showing Strong Responses with Breyanzi

Bristol Myers Squibb recently unveiled the primary results from the TRANSCEND FL study, focusing on the efficiency of Breyanzi (lisocabtagene maraleucel, or liso-cel) in treating patients with marginal zone lymphoma (MZL) that are either relapsed or refractory. This revelation, made at the 2025 International Conference on Malignant Lymphoma, provides a significant insight into the efficacy of this innovative treatment.

A substantial portion of the study's participants with relapsed or refractory MZL showed promising responses when treated with liso-cel. Impressively, 95.5% of these patients achieved a positive response, with 62.1% reaching a complete response. The ability of liso-cel to maintain a response at 24 months stood at 88.6%, illustrating its enduring impact. These outcomes highlight the potential of this therapy to offer a transformative solution to patients battling with challenging cases of MZL.

The TRANSCEND FL study involved patients with relapsed or refractory MZL treated with liso-cel at a target dose of 100 x 10^6 CAR-positive viable T cells. The results demonstrated a substantial clinical benefit. The overall response rate was 95.5%, with a significant number of patients achieving a complete response. The study reported a 24-month progression-free survival rate of 85.7% and an overall survival rate of 90.4%.

Liso-cel was noted for its consistent safety profile, with manageable rates of cytokine release syndrome (CRS) and neurologic events (NE). Severe CRS occurred in only 4% of patients, with no severe Grade 4/5 instances. Similarly, severe neurologic events were rare, occurring in 4% of cases. The study continues to monitor the response rates and safety to ensure comprehensive data.

Dr. M. Lia Palomba from Memorial Sloan Kettering Cancer Center highlighted the potential of liso-cel to significantly advance patient outcomes. Given that patients with multiple relapses of MZL face a median survival of 3 to 5 years, the need for such transformative therapies is urgent. The results of the TRANSCEND FL study underscore the promise of liso-cel in addressing this critical medical need.

Bristol Myers Squibb is committed to advancing the capabilities of cell therapy to improve patient care. Rosanna Ricafort, a senior leader at the company, emphasized the importance of the TRANSCEND FL findings in demonstrating the potential of cell therapy to alter treatment landscapes for relapsed or refractory lymphomas.

Beyond MZL, Bristol Myers Squibb is actively researching liso-cel’s potential in various forms of lymphoma. The company presented additional findings at the ICML 2025, highlighting liso-cel's effectiveness across different patient subgroups and its promising safety profile. These data points further advocate for the broad application of liso-cel in treating challenging cases of B-cell malignancies.

The TRANSCEND FL study is a part of Bristol Myers Squibb’s broader efforts to enhance therapeutic options for indolent B-cell non-Hodgkin lymphoma, including follicular and marginal zone lymphoma. With a focus on measuring overall response rates and secondary outcomes like complete response rate and progression-free survival, the study aims to provide comprehensive insights into the efficacy of Breyanzi.

Marginal zone lymphoma, a prevalent form of lymphoma among older adults, often leads to multiple relapses over the years, making effective treatment crucial. Breyanzi, a CD19-directed CAR T cell therapy, represents a significant advance in the treatment of such cases, offering the potential for long-term remission with a single infusion. Its approval in various countries underscores its global significance in the fight against relapsed or refractory B-cell lymphomas.

Bristol Myers Squibb continues to build on its pioneering work in cell therapy, striving to enhance patient outcomes across various types of blood cancers. Through ongoing research and clinical trials, the company aims to harness the full potential of cell therapy, making a meaningful impact on patient care worldwide.

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