City of Hope to provide first-ever FDA-approved CAR-T cell therapy for adult patients with certain types of large B-cell lymphomaOctober 18, 2017
The cancer center will be one of the first in the nation to offer axicabtagene ciloleucel, a significant breakthrough in treatment for one of the most common cancers in the U.S.
DUARTE, Calif. — City of Hope, a world-renowned independent research and treatment center for cancer and diabetes, will be one of the first authorized centers in the nation to provide axicabtagene ciloleucel, which the U.S. Food and Drug Administration (FDA) announced today is the first approved CAR-T cell therapy for adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. This is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL).
Axicabtagene ciloleucel, a Kite Pharma Inc. product, is a therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein found on the cell surface of NHL as well as other lymphoma and leukemia cells. CAR-T cell therapy harnesses the power of a patient’s own immune system by engineering T cells to recognize and attack cancer cells.
“City of Hope has been a pioneer in CAR-T therapy for nearly two decades. CAR-T therapy research is part of our deep commitment to advancing the most innovative treatments for cancer patients worldwide,” said Steven T. Rosen, M.D., City of Hope’s provost and chief scientific officer. “Today’s FDA approval of axicabtagene ciloleucel marks an important milestone and advance in cell-based therapy for NHL patients. City of Hope is uniquely positioned to begin offering treatment immediately to those patients who desperately need new treatment options.”
City of Hope’s history with CAR-T cell therapy dates back to the late 1990s. Since then, more than 150 patients have been treated in CAR-T trials at City of Hope, and the institution was the first to conduct CAR-T clinical trials in acute myeloid leukemia and glioblastoma, an aggressive brain tumor. City of Hope, which has one of the most comprehensive CAR-T cell clinical research programs in the world, currently has 13 CAR-T clinical trials ongoing and plans to open nine additional trials in 2018, including for patients with multiple myeloma, prostate cancer and breast cancer.
City of Hope’s expertise in developing and delivering cell-based therapies extends over more than four decades. City of Hope has been a worldwide leader in bone marrow and stem cell transplants, having performed more than 14,000 such procedures, making it one of the largest and most successful programs of its kind in the U.S. City of Hope’s unique blend of multidisciplinary specialization – encompassing physicians, nurses and intensive care and transfusion medicine experts sharing stem cell transplant expertise – will also benefit CAR-T patients.
“Key to City of Hope’s success in advancing lifesaving CAR-T cell therapy is our legacy of patient-centered care – treating not just the illness, but caring for the entire patient,” said Stephen J. Forman, M.D., the Francis & Kathleen McNamara Distinguished Chair in Hematology and Hematopoietic Cell Transplantation and leader of the Hematologic Malignancies and Stem Cell Transplantation Institute. “City of Hope has the expertise, knowledge and highly trained staff to successfully deliver axicabtagene ciloleucel to patients while continuing to advance clinical trials for additional CAR-T therapies to save even more lives.”
Lymphoma is the most common form of blood cancer, with Hodgkin lymphoma and NHL, which accounts for 4 percent of all cancer diagnoses in the United States, being the two main forms. Sixty percent of all NHL cases in the United States are aggressive NHL, with the most common subtype being diffuse large B-cell lymphoma.
Approximately 72,240 people children and adults will be diagnosed with NHL in 2017, according to the American Cancer Society.
NHL includes multiple different subtypes, all originating in the lymphatic system, and occurs when either B or T cell lymphocytes, a type of white blood cell, become abnormal, causing such painful symptoms as enlarged lymph nodes, fever and fatigue. Refractory, or treatment-resistant, aggressive NHL grow quickly over time. Historically, patients have had about a 50 percent chance of surviving six months. Patients whose disease is resistant to current treatment, including various types of chemotherapy, radiation and bone marrow stem cell transplants, are eligible to receive axicabtagene ciloleucel.
The axicabtagene ciloleucel approval is supported by data from the ZUMA-1 phase 1 and phase 2 trials; City of Hope was one of the first four centers worldwide to enroll patients in the phase 1 trial. In the ZUMA-1 phase 2 trial, of the 101 patients enrolled, 82 percent of patients who received a single infusion had a measurable response, meaning their lymphoma improved after treatment. After a follow-up of 8.7 months, 44 percent of patients still had a response to the therapy, which included 39 percent of patients whose lymphoma had disappeared completely. The eligible patient population for axicabtagene ciloleucel is approximately 7,500 patients.
Patients with refractory aggressive non-Hodgkin lymphoma who are interested in learning more about the new treatment can contact City of Hope at 800-934-5555.
About City of Hope
City of Hope is an independent research and treatment center for cancer, diabetes and other life-threatening diseases. Designated as one of only 49 comprehensive cancer centers, the highest recognition bestowed by the National Cancer Institute, City of Hope is also a founding member of the National Comprehensive Cancer Network, with research and treatment protocols that advance care throughout the world. City of Hope is located in Duarte, California, just northeast of Los Angeles, with community clinics throughout Southern California. It is ranked as one of "America's Best Hospitals" in cancer by U.S. News & World Report. Founded in 1913, City of Hope is a pioneer in the fields of bone marrow transplantation, diabetes and numerous breakthrough cancer drugs based on technology developed at the institution.
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