Pivotal CAR-T therapy cancer study published in the New England Journal of Medicine

HACKENSACK, N.J., Dec. 22, 2017 /PRNewswire-USNewswire/ -- Hackensack Meridian Health - John Theurer Cancer Center at Hackensack University Medical Center is the only New Jersey center that participated in a pivotal clinical trial of a groundbreaking cancer treatment, CAR-T Cell therapy, which genetically modifies a patient's immune system to attack cancer cells.

André Goy, M.D., chairman and director, chief of Lymphoma, and director of Clinical and Translational Cancer Research at John Theurer Cancer Center, is a co-author of the study, presented at the 59^th Annual Meeting of the American Society of Hematology and published on December 10, 2017 in the New England Journal of Medicine.

"For nearly a decade, John Theurer Cancer Center has been involved in CAR T-Cell research and the developments that led to the approval of this therapeutic modality," said Dr. Goy. "I believe it will radically change the paradigm in several subtypes of hematological malignancies or blood cancers."

Hackensack University Medical Center is the only institution in New Jersey certified to provide CAR-T cell therapy and is developing a dedicated CAR-T Cell therapy unit for adult patients with relapsed or refractory aggressive Non-Hodgkin lymphoma, as well as acute lymphoblastic leukemia in children and young adults.

"With over 6,500 transplants performed to date, John Theurer Cancer Center physicians are among the most experienced in treating advanced cancers with immunotherapy, including in cell therapies," said Ihor Sawczuk, M.D., president, Hackensack University Medical Center. "The CAR-T Cell unit will expand our robust portfolio of trials in all forms of cell therapies, and offer additional treatment options to produce long-term remissions for patients with refractory blood cancers."

The CAR-T Cell treatment used in the study, is offered by Kite Pharma. Two other companies, Novartis and Juno Therapeutics, are also developing CAR-T Cell therapies.

Based on results of the study, the Food and Drug Administration approved a CAR-T treatment called xicabtagene ciloleucel or Yescarta. The study included 111 patients from 22 centers, including John Theurer Cancer Center. The patients had refractory large B-cell lymphoma -who failed chemotherapy- or patients who relapsed early after stem cell transplantation.

"Such patients unfortunately have no real options currently outside of an allogenic stem cell transplantation, which requires the patient to have chemo-sensitive disease - allowing time for the new immune system to develop - so it is really rare that this population of patients can undergo allogenic stem cell transplantation," says Dr. Goy.

The basis of this new cell therapy is to harness the patient's own T-cells, or white blood cells that are part of the immune system. T-cells are collected from the patient and sent to the manufacturing lab. There, the cells are genetically modified through introduction of a gene that instructs the cells to target and kill lymphoma cells. These genetically modified T-cells are then expanded in the lab before being infused back into the patient.

In the study, T-cells were successfully produced and expanded in 99 percent of patients. Eighty-four percent of patients responded, with 42 percent of all patients achieving a complete remission. More than half of all patients were alive as of 15.4 months.

"This is simply unprecedented in such a population," says Dr. Goy. "There are very few relapses after six months and several patients from the study early on have been in remission for over two years, and are likely cured."

Regarding toxicity, 95 percent of patients experienced at least one side effect that was severe. The most common adverse events of grade 3 or higher during treatment were neutropenia (in 78 percent of the patients), anemia (in 43 percent), and thrombocytopenia (in 38 percent). Grade 3 or higher cytokine release syndrome (released because of overstimulation of the immune system with CAR T-cells expanding) and neurologic events occurred in 13 percent and 28 percent of the patients, respectively. The use of low dose steroids and/or monoclonal antibody anti-IL6 receptor (to block one of the commonly found elevated cytokines IL6), tocilizumab, has dramatically helped manage toxicities.

"The early amplification of T-cells usually correlates with the response in patients, so controlling side effects – without interfering with T-cell expansion and their activity is critical," said Dr. Goy.

Ongoing studies are looking at improving both toxicities and efficacy of CAR T-cell therapy using combinations particularly with checkpoint inhibitors.  

"The most difficult-to-treat cancers require the most complex treatments, such as CAR-T Cell therapy— which require the most experienced physicians to deliver them safely," said Andrew Pecora, M.D., chief innovation officer and president of Physician Services at Hackensack Meridian Health. "Collectively, the physicians at John Theurer Cancer Center have among the most hands-on experience in applied cell therapy in the world – pioneers in blood and marrow stem cell transplantation -- and we're building on our legacy to provide the next generation of cancer care."

The study, "Axicagagene Ciloleucel (CD19 CAR T) in Refractory Large B-Cell Lymphoma," was led by Sattva Neelapu, MD, of the MD Anderson Cancer Center and Frederick Locke, MD, of the H. Lee Moffitt Cancer Center and Research Institute.

ABOUT JOHN THEURER CANCER CENTER AT HACKENSACK UNIVERSITY MEDICAL CENTER

John Theurer Cancer Center at Hackensack University Medical Center is New Jersey's largest and most comprehensive center dedicated to the diagnosis, treatment, management, research, screenings, and preventive care as well as survivorship of patients with all types of cancers. The 14 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. Housed within Hackensack University Medical Center, 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.

SOURCE John Theurer Cancer Center

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