Breyanzi Shows Durable Responses in R/R Marginal Zone Lymphoma

Breyanzi demonstrated a 95.5% response rate among in relapsed/refractory marginal zone lymphoma: © stock.adobe.com.

Breyanzi (liso-cel; lisocabtagene maraleucel) demonstrated high rates of durable responses and a consistent safety profile in patients with relapsed or refractory marginal zone lymphoma, according to a news release from Bristol Myers Squibb.

This marks the fifth cancer type in which Breyanzi has shown high rates of durable responses and a consistent safety profile, which is notably the most of any CD19-directed CAR T-cell therapy.

Patients with relapsed or refractory marginal zone lymphoma treated with Breyanzi achieved a 95.5% response rate, with 62.1% having complete responses and 88.6% ongoing at 24 months. At 24 months, duration of response, progression-free survival, and overall survival rates were 88.6%, 85.7%, and 90.4%, with median follow-ups of 21.6 to 24.5 months.

“[Breyanzi] achieved high, lasting response rates in patients with relapsed or refractory marginal zone lymphoma, underscoring the potential of this one-time therapy to significantly improve patient outcomes,” Dr. M. Lia Palomba, TRANSCEND FL study investigator and lymphoma and cell therapy specialist at Memorial Sloan Kettering Cancer Center, said in the news release. “Currently, the median survival for patients with marginal zone lymphoma with multiple relapses is three to five years, signifying an urgent need for transformative therapies that can effectively address this hard-to-treat disease.”

Breyanzi continued to show a consistent safety profile, with low rates of severe cytokine release syndrome and neurologic events, as well as no new safety concerns identified.

Cytokine release syndrome — when the immune system overreacts causing fever and inflammation — occurred in 76% of patients, including 4% with grade 3 (severe) side effects and no grade 4 (life-threatening) or grade 5 (death) side effects. Neurologic side effects were seen in 33% of patients, including 4% with grade 3 side effects and no grade 4 or 5 side effects. The study remains ongoing to assess overall response rate and safety in the final analysis.

TRANSCEND FL is a global, phase 2 clinical trial testing Breyanzi in adults with indolent B-cell non-Hodgkin lymphoma who have relapsed or whose disease did not respond to prior treatments. This includes two lymphoma types: follicular lymphoma and marginal zone lymphoma. The main goal of the study is to measure how many patients experience tumor shrinkage or disappearance (overall response rate). Researchers also track how many patients achieve complete remission, how long the response lasts, and how long patients live without disease progression.

Within this trial, the marginal zone lymphoma cohort included patients who received Breyanzi after at least two prior therapies. Each patient was given a dose targeting 100 x 10⁶ CAR-positive viable T cells.

Breyanzi and its Previous Approvals

Breyanzi is a CD19-directed CAR T cell therapy that includes a 4-1BB costimulatory domain, which helps enhance the expansion and persistence of the CAR T cells in the body. It is made from a patient’s own T cells, which are collected and genetically reengineered to target cancer cells. These modified CAR T cells are then given back to the patient through a one-time infusion.

In the United States, Breyanzi is approved to treat several types of blood cancers. It is used for relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior treatment. It also has accelerated approval for relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior treatments. Additionally, Breyanzi is approved for relapsed or refractory follicular lymphoma in patients who have received at least two prior therapies and for relapsed or refractory mantle cell lymphoma in the third-line or later setting.

Breyanzi is also approved in Japan, the European Union, Switzerland, the United Kingdom, and Canada for similar uses, including relapsed or refractory LBCL and follicular lymphoma, with some differences depending on prior lines of therapy.

Reference:

“Bristol Myers Squibb presents first data from the marginal zone lymphoma cohort of the Transcend FL trial demonstrating deep and durable responses with Breyanzi (lisocabtagene maraleucel),” Bristol Myers Squibb News, June 16, 2025.

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