“The approval of this BREYANZI offers another highly effective CAR-T option for patients with relapsed/refractory large B cell lymphoma,” said Scott Solomon, medical director of Northside’s Blood and Marrow Transplant (BMT) Matched Unrelated Donor Program and Stem Cell Processing Laboratory. “A major difference between BREYANZI and other currently available CAR-T products involves the separation of the patient’s CD4 and CD8 T cells prior to manufacturing and then administration of each cell type back to the patient in equal target doses; this produces a consistent product for each patient.”
DLBCL is a fast-growing, aggressive disease. According to the Leukemia & Lymphoma Society, it is the most common non-Hodgkin’s lymphoma, with more than 25,000 cases diagnosed each year. CAR T-cell therapy is one of several types of immunotherapy used to treat the disease. Immunotherapy is essentially strengthening and empowering a patient’s own immune system to find and attack cancer. It works by taking immune cells, genetically modifying them to be better tumor-fighting immune cells, multiplying them to great numbers (tens of thousands), and then infusing them into the patient.
“Although CD19-targeted CAR T cell therapies have emerged as highly effective, potentially curative therapies, they do carry significant risks, including cytokine release syndrome (CRS) and neurologic toxicities,” said Dr. Solomon. “BREYANZI was designed to try to maximize both efficacy and safety; the TRANSCEND study, which led to its recent FDA approval, showed relatively low rates of severe CRS and neurological toxicity as well as the feasibility of outpatient administration, which is meaningful for patients, physicians and the health care system.”
“I think the favorable balance of efficacy and safety may make BREYANZI the CAR T-cell therapy of choice in patients with relapsed/refractory large B-cell lymphomas,” Dr. Solomon added.
BREYANZI is the fourth CAR T-cell therapy available at Northside. In 2018, NHCI became one of a select group of certified centers in the country to offer Yescarta™ CAR T-cell therapy for adult patients with certain types of non-Hodgkin lymphoma. The program also offers Kymriah® for treatment of adult acute lymphoid leukemia and certain types of non-Hodgkin’s lymphoma, and TECARTUS™ for adult patients with relapsed or refractory mantle cell lymphoma (MCL).
BREYANZI is NOT indicated for the treatment of patients with primary central nervous system lymphoma.
- Demonstrated a 73% overall response rate and 54% complete response (CR) rate in the largest pivotal trial in 3L+ LBCL, TRANSCEND NHL 001 trial.
- Sustained responses in patients who achieved a CR with median duration of response not reached.
- Grade ≥3 cytokine release syndrome and Grade ≥3 neurologic toxicities following BREYANZI treatment occurred in 4% and 12% of patients, respectively.
- CAR T-cell therapy is a promising personalized immunotherapy treatment that uses a patient’s own T cells to eliminate malignant cancer cells.