Newswise — HACKENSACK, N.J. (DATE TK) — A new study has found that using CAR T-cell therapy as the second line of treatment for diffusing large B-cell lymphoma (DLBCL) that has returned or continued to grow after initial treatment was more effective than the standard second-line regimen of care for improving event-free survival (EFS / defined as disease progression, needing to start a new lymphoma treatment, or death from any cause). Investigators from Hackensack Meridian/Hackensack University Medical Center’s John Theurer Cancer Center (JTCC), a part of Georgetown Lombardi Comprehensive Cancer Center, participated in the multicenter international study, called ZUMA-7.
With a median follow-up of two years, the study showed that patients with DLBCL who received a one-time infusion of axicabtagene ciloleucel (Yescarta®) experienced a 60% improvement in EFS compared with patients who received standard care with chemotherapy and autologous stem cell transplantation. Patients in the CAR T-cell therapy group also experienced a better overall response rate. The study is continuing with additional follow-up to assess the effect of the treatments on overall survival and other key endpoints.
Axicabtagene ciloleucel is currently approved by the U.S. Food and Drug Administration for the treatment of large B-cell lymphoma that relapses after or fails to respond to at least two prior regimens of therapy.
"This is a very exciting paradigm shift for the treatment of large B-cell lymphoma," explained hematologist-oncologist Lori Leslie, M.D., who led JTCC's participation in the ZUMA-7 study. "A 60% improvement in event-free survival is more dramatic than one would anticipate and suggests that early relapsers and some patients at high risk of relapse after initial treatment may benefit from proceeding directly to CAR T-cell therapy."
About 40% of patients with DLBCL will need a second regimen of treatment.
CAR T-cell therapy is a form of treatment which involves removing white blood cells called T cells from the patient, modifying them in the laboratory to train them to see a protein (called CD19) on lymphoma cells, and then multiplying them to much larger numbers. When given back to the patient intravenously, they expand further, ideally identifying and killing cancer cells anywhere in the body. CAR T-cell therapy is a form of immunotherapy and has been called a "living therapy" because the newly trained T cells continue to find and destroy cancer cells in the body.
“As a leader in CAR T therapy, we are proud to be a part of this new development in research that will continue to reshape the landscape of relapsed/refractory aggressive lymphoma who fail standard regimens of chemoimmunotherapy,” said Andre Goy, M.D., M.S., chairman and executive director of John Theurer Cancer Center.
The ZUMA-7 study began in 2017 and includes 359 patients with DLBCL at 77 medical centers around the world, 30% of whom were 65 years or older. Side effects observed in the study were consistent with or even more favorable than the safety profile previously established for axicabtagene ciloleucel. The use of CAR T-cell therapy as second-line treatment did not result in any new safety concerns. Yescarta has been instrumental in transforming outcomes for DLBCL patients in third line setting. It is likely the paradigm will continue to shift towards earlier timing in patients with early failures.
"The contributions that the John Theurer Cancer Center made toward identifying a better therapy for the research and treatment of lymphoma further establishes its position as a leading center, " said Ihor Sawczuk, MD, FACS, president, Northern Region, and chief research officer, Hackensack Meridian Health. "Hackensack Meridian Health is proud to have been involved in this pivotal study."
"We are dedicated to continuing to provide the latest research-based treatments to the members of our communities," added Mark D. Sparta, FACHE, president and chief hospital executive, Hackensack University Medical Center and executive vice president of Population Health, Hackensack Meridian Health. "John Theurer Cancer Center was the first center in New Jersey to be certified to offer CAR T-cell therapy and was active in research assessing its use long before its first FDA approval. We are very excited to see these promising results, which show how this powerful immunotherapy may benefit more people."
ABOUT JOHN THEURER CANCER CENTER HACKENSACK UNIVERSITY MEDICAL CENTER
John Theurer Cancer Center at Hackensack University Medical Center is New Jersey's best cancer center, as recognized by U.S. News & World Report. As a premier cancer center in the State we are also the largest and most comprehensive center dedicated to diagnosis, treatment, management, research, screening, and preventive care as well as survivorship of patients with all types of cancers. The 16 specialized divisions covering the complete spectrum of cancer care have developed a close-knit team of medical, research, nursing, and support staff with specialized expertise that translates into more advanced, focused care for all patients. Each year, more people in the New Jersey/New York metropolitan area turn to John Theurer Cancer Center for cancer care than to any other facility in New Jersey. John Theurer Cancer Center is part of the Georgetown Lombardi Comprehensive Cancer Center, an NCI designated comprehensive cancer center. Housed within a 775-bed not-for-profit teaching, tertiary care, and research hospital, John Theurer Cancer Center provides state-of-the-art technological advances, compassionate care, research innovations, medical expertise, and a full range of aftercare services that distinguish John Theurer Cancer Center from other facilities. For additional information, please visit www.jtcancercenter.org