SEATTLE — February 18, 2021 — Seattle Cancer Care Alliance (SCCA), the only NCCN-designated cancer center in Washington State, has been selected as an authorized treatment center for the new chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel, also known as liso-cel and by the brand name BreyanziTM. Liso-cel was approved by the U.S. Food and Drug Administration (FDA) on February 5, 2021.
The CD19-directed CAR T-cell therapy is indicated for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B. Liso-cel is not indicated for the treatment of patients with primary central nervous system lymphoma. According to the pivotal multi-center phase 1 TRANSCEND NHL 001 trial, treatment with liso-cel resulted in a response rate of 73% and a complete response (CR) rate of 53%; these data supported the priority review granted by the FDA in mid-2020.
“The recent FDA approval of lisocabtagene maraleucel marks a significant step forward in CAR T-cell therapies for the treatment of large B-cell lymphoma, offering a potential life-saving option for those whose cancer hasn’t responded to other treatments or has returned,” said David Maloney, MD, PhD, medical director for cellular immunotherapy at the Bezos Family Immunotherapy Clinic at Seattle Cancer Care Alliance. “We are very excited to be one of the authorized centers to offer an advancing therapy that has the potential to benefit more than 80,000 patients nationwide.”
Large B-cell lymphoma is the most common type of non-Hodgkin lymphoma and is a rapidly growing, aggressive disease, accounting for one of every three non-Hodgkin lymphoma cases diagnosed, according to the American Cancer Society. When large B-cell lymphoma has returned following treatment or not responded to treatment, it is considered to have reached relapsed or refractory state. According to previous studies, as many as 73% of patients will not respond to second-line treatment, or they will relapse. In patients who relapse or do not respond to initial therapies, conventional treatment options that provide sustained responses are limited, with an average life expectancy of about six months.
The liso-cel treatment is prepared from a patient’s own cells. Blood is withdrawn, T cells are separated and then undergo genetic “reprogramming” to become CAR T cells, which are multiplied for the patient’s appropriate dose and administered via an infusion at a treatment center like SCCA’s Bezos Family Immunotherapy Clinic. Liso-cel has been infused and monitored in outpatient settings in three trials. According to a study presented last year involving three on-going trials (TRANSCEND NHL 001, Outreach and PILOT), the need for hospitalization was low following treatment with liso-cel. After the first month of treatment, approximately 40% of patients did not require hospitalization.
“SCCA’s mission is to ensure that our patients have access to the latest treatment advances and leading-edge therapies,” said Nancy Davidson, MD, president and executive director of Seattle Cancer Care Alliance. “We are pleased to add another treatment offering to patients suffering from relapsed or refractory large B-cell lymphoma and advance our mission of pursuing better, longer, richer lives for our patients.”
With this latest FDA approval, SCCA is one of the first cancer treatment centers in the United States to offer all four FDA-approved CAR T-cell therapies. The organization provides a broad range of treatment resources and advanced clinical trials; there are currently 20 cellular therapy clinical trials open for enrollment. The organization is home to several of the world’s leading immunotherapy experts whose research has contributed to the foundation of many immunotherapies currently used to treat cancer. SCCA’s Bezos Family Immunotherapy Clinic, which opened in 2016, is a state-of-the-art center dedicated to offering the newest clinical trials and therapies in cellular immunotherapy.
Fred Hutch Media Team