Among adults with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, the phase 2 TRANSCEND FL trial met its primary end goal in the marginal zone lymphoma cohort, which evaluated the efficacy of Breyanzi (lisocabtagene maraleucel), according to a news release from the drug’s manufacturer, Bristol Myers Squibb.
Specifically, results demonstrated a statistically significant and clinically meaningful overall response rate in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma. The study also met key secondary end goals of complete response rate, and in a topline analysis, Breyanzi continued to show durable responses and a consistent safety profile with no new safety signals observed.
“Marginal zone lymphoma is a slow-growing cancer that, for many, has a favorable prognosis. But for those patients who relapse or become refractory, the disease can be quite aggressive, and there is a need for new effective and tolerable treatment options to address this unmet critical need,” Rosanna Ricafort, vice president, head of Late Development Program Leadership, Hematology and Cell Therapy, Bristol Myers Squibb, said in the news release. “We are pleased that the TRANSCEND FL study supports the potential of Breyanzi in marginal zone lymphoma and look forward to presenting detailed results from the study at an upcoming medical meeting.”
Glossary:
Overall response rate: percentage of patients showing a positive response.
Complete response: full disappearance of disease symptoms.
Diffuse alveolar damage: widespread lung tissue injury.
Cerebral edema: swelling of the brain.
Leukoencephalopathy: white matter brain disease.
Renal insufficiency: reduced kidney function.
Capillary leak syndrome: fluid leakage from blood vessels.
Hemophagocytic lymphohistiocytosis/macrophage activation syndrome: severe immune activation causing tissue damage.
Tachycardia: abnormally fast heart rate.
Hypoxia: low oxygen levels in tissues.
Hypotension: low blood pressure.
Marginal zone lymphoma is a slow-growing non-Hodgkin lymphoma that accounts for 7% of NHL cases, typically diagnosed at a median age of 67. It develops when white blood cells form lumps in lymph nodes or organs and occurs in three forms: extranodal (60%), nodal (30%) and splenic (10%), according to the release.
The news release also states that after the results from the phase 2 TRANSCEND FL trial, Breyanzi showed efficacy and manageable safety in a fifth cancer type. This marks the most of any CD19-directed CAR T-cell therapy.
Among 702 patients with non-Hodgkin lymphoma (NHL) in clinical trials of Breyanzi, cytokine release syndrome (CRS) occurred in 54%, including grade 3 (severe) or worse in 3.2% of patients. The median time to onset was five days, and CRS resolved in 98% of patients with a median duration of five days. One patient had fatal CRS, and five had ongoing CRS at death. The most common CRS symptoms (10% or more) included fever, hypotension, tachycardia, chills, hypoxia and headache.
Serious CRS-associated events included cardiac arrhythmias, cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia and hemophagocytic lymphohistiocytosis/macrophage activation syndrome.
Furthermore, serious events, including cerebral edema and seizures, were reported, and fatal and serious leukoencephalopathy cases, some linked to fludarabine, also occurred.
According to the news release, Breyanzi is a CD19-directed CAR-T cell therapy that uses a 4-1BB costimulatory domain to enhance CAR-T cell expansion and persistence. It is made from a patient’s own T cells, which are collected, genetically modified and infused as a one-time treatment for various relapsed or refractory B-cell lymphomas.
Breyanzi currently is approved for adults with large B-cell lymphoma, including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B. It is indicated for those with refractory disease or relapse within 12 months of first-line chemoimmunotherapy, those ineligible for hematopoietic stem cell transplant due to age or comorbidities or those with relapsed or refractory disease after two or more systemic therapies.
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