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John Theurer Cancer Center First NJ Site Certified to offer CAR-T Cell Cancer Therapy

Breakthrough gene therapy for B-cell lymphoma now available at Hackensack University Medical Center

John Theurer Cancer Center at Hackensack Meridian Health Hackensack University Medical Center is among limited U.S. sites, and the only hospital in New Jersey certified to offer Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded or who have relapsed after at least two other kinds of treatment.

“John Theurer Cancer Center has been involved in CAR-T cell therapy research for nearly a decade,” said André Goy, M.D., chairman and executive director of the John Theurer Cancer Center, chief of the Lymphoma Division, professor of medicine at Georgetown University. Dr. Goy co-authored the study, Axicagagene Ciloleucel (CD19 CAR T) in Refractory Large B-Cell Lymphoma, presented at the 59th Annual Meeting of the American Society of Hematology and published on December 10, 2017 in the New England Journal of Medicine.  “This new therapeutic modality represents the first gene modified cell based live therapy approved for adults, and will radically change the paradigm in several subtypes of hematological malignancies or blood cancers.”

Each dose of CAR-T cell therapy is a customized treatment created using a patient’s own immune system to help fight the lymphoma. The patient’s T-cells, a type of white blood cell, are collected and genetically modified to include a new gene that targets and kills the lymphoma cells. Once the cells are modified, they are infused back into the patient.

“Our world-renowned cancer experts have helped pioneer immune-based advancements like CAR-T cell therapy,” said Robert C. Garrett, co-CEO, Hackensack Meridian Health. “With the depth and breadth of experience among our multidisciplinary oncology team, John Theurer Cancer Center is treating the most complex and difficult cases.”

Diffuse large B-cell lymphoma (DLBCL) is the most common type of Non Hodgkins Lymphoma (NHL) in adults. NHLs are cancers that begin in certain cells of the immune system and can be either fast-growing (aggressive) or slow-growing. Approximately 72,000 new cases of NHL are diagnosed in the U.S. each year, and DLBCL represents approximately one in three newly diagnosed cases.

Yescarta was approved by the FDA for use in adult patients with large B-cell lymphoma after at least two other kinds of treatment failed, including DLBCL, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

The first CAR-T cell therapy, Kymriah, was approved in 2017 by the FDA to treat children and young adults who have a challenging form of acute lymphoblastic leukemia (ALL). Hackensack University Medical Center was also the first hospital in NJ certified to offer this therapy for patients up to age 25.

“The recent certifications of John Theurer Cancer Center and Joseph M. Sanzari Children’s Hospital to provide CAR-T cell therapy reflect Hackensack University Medical Center’s commitment to research and innovation in the provision of the highest quality cancer care,” said Ihor S. Sawczuk, M.D., FACS, president of Hackensack University Medical Center.

“Our pediatric oncology immunotherapy program will target a common childhood leukemia. Eligible patients will have exhausted all standard therapies and have refractory disease or have relapsed,” said Alfred P. Gillio, M.D., co-director, Children’s Cancer Institute, section chief, Pediatric Blood and Marrow Transplantation. “This therapy has resulted in long-term remissions in the majority of patients treated to date and is a major advance in the search for a cure for childhood leukemia.”

“CAR T-cell therapy is the next-generation therapy to augment stem cell transplantation,” said Andrew L. Pecora, M.D., FACP, CPE, president of Physician Enterprise and chief innovation officer, Hackensack Meridian Health, and professor of medicine and oncology at Georgetown University. “John Theurer Cancer Center has some of the most experienced physicians in cell-based therapies in the world to safely deliver CAR T-cells.”

John Theurer Cancer Center Involvement

John Theurer Cancer Center has been involved in several studies of CAR T-cells since the National Cancer Institute’s original study (J Clin Oncol 2015;33:540-549), and is one of the limited centers nationwide offering this new technology. With more than 6,500 stem cell transplants performed to date, including 40 percent allogeneic transplants, John Theurer Cancer Center has an excellent reputation and strong team with extensive experience in cell therapy. This includes donor lymphocyte infusion that is given to prevent or fight relapse in high-risk patients with blood cancers.

“The high CR rate and durability of responses seen with anti-CD19 CAR T-cells suggest this therapy could have the potential for a cure in a population of heavily pretreated B-cell ALL or DLBCL patients who have no available or lasting options in that setting,” Dr. Goy said. “Though much still needs to be learned about mechanisms of resistance and persistence of CAR T-cells in vivo, as well as biomarkers predictive of response, the primary factor of efficacy seems to be the initial amplification of T-cells after reinfusion.”

Not surprisingly, this rapid immunologic response is accompanied by side effects, particularly cytokine release syndrome (CRS) and a variable degree of neurologic toxicity. It was found somewhat serendipitously early on in clinical trials that CRS can be treated successfully (69 percent resolution of CRS symptoms within two weeks) with an interleukin-6 blocker, tocilizumab (Actemra, Genentech), which is already marketed for use in rheumatoid arthritis. This discovery led to the recent FDA expansion of its indication to include treatment of CAR T-cell–induced severe or life-threatening CRS.

“Most symptoms occur within the first three weeks post-infusion and require close monitoring to handle these patients, who at John Theurer Cancer Center are managed by a dedicated team of multidisciplinary experts,” Dr. Goy said. Appropriately, only a limited number of centers, which must be certified, will be able to provide these therapies.

The Fourth and Fifth Modalities of Cancer Care
“We are without a doubt entering a new era in cancer,” Dr. Goy said. “For years, the foundation of cancer treatment was surgery, chemotherapy and radiation therapy. Over the last two decades, targeted therapies have cemented themselves as the fourth modality of therapy.” Examples include imatinib for chronic myeloid leukemia; trastuzumab (Herceptin, Genentech) for breast cancer; proteasome inhibitors (bortezomib [Velcade, Millennium], carfilzomib [Kyprolis, Amgen]) and immunomodulatory drugs, such as lenalidomide (Revlimid, Celgene), for multiple myeloma (MM); and ibrutinib (Imbruvica, Pharmacyclics) for chronic lymphocytic leukemia (CLL) and mantle cell lymphoma. “John Theurer Cancer Center played a pivotal role in the development and approval process of most of these agents, which will supplement or even supplant chemotherapy.”

The fifth pillar of cancer treatment is now immunotherapy. These therapies include checkpoint inhibitors (CPIs) such as nivolumab (Opdivo, Bristol-Myers Squibb), ipilimumab (Yervoy, Bristol-Myers Squibb) and pembrolizumab (Keytruda, Merck), among others. “CPIs have already changed treatment approaches in many subtypes of solid tumors as well as in some lymphomas, such as Hodgkin disease. Again, John Theurer Cancer Center was involved in key aspects of approval, particularly through our dedicated Phase 1 unit.”

Dr. Goy added, “The adoptive cell therapy for which CAR T-cells is the first example will without any doubt expand to other B-cell malignancies, including other lymphomas, CLL and MM, with ongoing studies at John Theurer Cancer Center as well. This technology will also be tested in acute myeloid leukemia (with anti-CD123 CAR T-cells), where we are also exploring the benefits of natural killer (NK) cells. Though early, given the results seen with CPIs in solid tumors, it is likely that use of CAR T-cell technology will in the future expand outside blood cancers.”

To learn more about CAR-T cell therapy at John Theurer Cancer Center, visit hackensackumc.org/services/cancer-care/services/car-t-cell-therapy/

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.

ABOUT JOSEPH M. SANZARI CHILDREN’S HOSPITAL AT HACKENSACK UNIVERSITY MEDICAL CENTER
Hackensack Meridian Health Joseph M. Sanzari Children’s Hospital provides comprehensive medical and surgical pediatric care in more than 30 sub-specialties, all integrated within a state-of–the-art child and family-focused facility. The Joseph M. Sanzari Children’s Hospital is designated by the State of New Jersey as a children’s hospital. It is also one of a select group designated a full institutional member of the Children’s Hospital Association. This designation honors the contributions of a dedicated team of health care professionals, team members and volunteers who have made the children’s hospital a world-class healing environment for children and their families for many years. More significantly, this designation builds on that commitment of care for children that Hackensack University Medical Center has always provided. The Joseph M. Sanzari Children’s Hospital received a Top 50 national ranking inPediatric Neurology and Neurosurgeryin U.S. News & World Report’s 2017-18 Best Children’s Hospitals. The Joseph M. Sanzari Children’s Hospital includes the Children’s Cancer Institute and Pediatric Emergency Department and offers the following services, programs and sub-specialties: The Audrey Hepburn Children’s House – a state-designated Regional Diagnostic Center for Child Abuse and Neglect serving Bergen, Passaic, Hudson, Morris, Sussex and Warren counties; Adolescent Medicine; Audiology: Blood and Marrow Transplantation (the only one in New Jersey); Cardiology; Community and CPR training; Child Life Services; Center for Pain and Palliative Care; Day Accommodation Suite; Dermatology; Gastroenterology and Nutrition; Genetics: Healthy Futures – Pediatric Weight Management; Hospitalists; Infectious Diseases; Inpatient Care Unites, Institute for Child Development; JUDY Center for Down Syndrome; Molly Center for Children with Diabetes and Endocrine Disorders; Neonatal Intensive Care Unit (NICU); Nephrology; Neurology; Otolaryngology; Pediatric Intensive Care Unit; Pediatric Surgery; Pulmonology; Rheumatology; Social Work; and the Steven and Richard Bader Immunological Institute. To learn more, visit http://kids.hackensackumc.org/.

About Hackensack Meridian Health Hackensack University Medical Center
Hackensack Meridian Health Hackensack University Medical Center, a 775-bed nonprofit teaching and research hospital located in Bergen County, NJ, is the largest provider of inpatient and outpatient services in the state. Founded in 1888 as the county’s first hospital, it is now part of one of the largest networks in the state comprised of 33,000 team members and more than 6,500 physicians. Hackensack University Medical Center was listed as the number one hospital in New Jersey in U.S. News & World Report’s 2017-18 Best Hospital rankings – maintaining its place atop the NJ rankings since the rating system was introduced. It was also named one of the top four New York Metro Area hospitals. Hackensack University Medical Center is one of only five major academic medical centers in the nation to receive Healthgrades America’s 50 Best Hospitals Award for five or more years in a row. Becker’s Hospital Review recognized Hackensack University Medical Center as one of the 100 Great Hospitals in America 2017. The medical center is one of the top 25 green hospitals in the country according to Practice Greenhealth, and received 23 Gold Seals of Approval™ by The Joint Commission – more than any other hospital in the country. It was the first hospital in New Jersey and second in the nation to become a Magnet® recognized hospital for nursing excellence; receiving its fifth consecutive designation in 2014. Hackensack University Medical Center has created an entire campus of award-winning care, including: the John Theurer Cancer Center; the Heart & Vascular Hospital; and the Sarkis and Siran Gabrellian Women’s and Children’s Pavilion, which houses the Joseph M. Sanzari Children’s Hospital and Donna A. Sanzari Women’s Hospital, which was designed with The Deirdre Imus Environmental Health Center and listed on the Green Guide’s list of Top 10 Green Hospitals in the U.S. Hackensack University Medical Center is the Hometown Hospital of the New York Giants and the New York Red Bulls and is Official Medical Services Provider to The Northern Trust PGA Golf Tournament. It remains committed to its community through fundraising and community events especially the Tackle Kids Cancer Campaign providing much needed research at the Children’s Cancer Institute housed at the Joseph M. Sanzari Children’s Hospital. To learn more, visit www.HackensackUMC.org.

ABOUT HACKENSACK MERIDIAN HEALTH
Hackensack Meridian Health is a leading not-for-profit health care organization that is the most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care. Hackensack Meridian Health comprises 16 hospitals from Bergen to Ocean counties, which includes three academic medical centers – Hackensack University Medical Center in Hackensack, Jersey Shore University Medical Center in Neptune, JFK Medical Center in Edison; two children’s hospitals – Joseph M. Sanzari Children’s Hospital in Hackensack, K. Hovnanian Children’s Hospital in Neptune; 11 community hospitals – Ocean Medical Center in Brick, Riverview Medical Center in Red Bank, Mountainside Medical Center in Montclair, Palisades Medical Center in North Bergen, Raritan Bay Medical Center in Perth Amboy, Southern Ocean Medical Center in Manahawkin, Bayshore Medical Center in Holmdel, Raritan Bay Medical Center in Old Bridge, and Pascack Valley Medical Center in Westwood, JFK Johnson Rehabilitation Institute in Edison and Shore Rehabilitation Institute in Brick.

Additionally, the network has more than 160 patient care locations throughout the state which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, fitness and wellness centers, rehabilitation centers, and urgent care and after-hours centers. Hackensack Meridian Health has 33,000 team members, and 6,500 physicians and is a distinguished leader in health care philanthropy, committed to the health and well-being of the communities it serves.

The network’s notable distinctions include having one of only five major academic medical centers in the nation to receive Healthgrades America’s 50 Best Hospitals Award for five or more consecutive years, four hospitals among the top 10 in New Jersey, including Hackensack University Medical Center which is ranked No. 1 by U.S. News and World Report. Other honors include consistently achieving Magnet® recognition for nursing excellence from the American Nurses Credentialing Center, recipient of the John M. Eisenberg Award for Patient Safety and Quality from The Joint Commission and the National Quality Forum, a six-time recipient of Fortune’s “100 Best Companies to Work For,” one of the “20 Best Workplaces in Health Care” in the nation, and the number one “Best Place to Work for Women.” Hackensack Meridian Health is a member of AllSpire Health Partners, an interstate consortium of leading health systems, to focus on the sharing of best practices in clinical care and achieving efficiencies.

For additional information, please visit www.HackensackMeridianHealth.org.