First FDA-approved CAR-T Cell Therapy for Lymphoma to Be Available at City of Hope
October 18, 2017 | by City of Hope
City of Hope will be the 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 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).
CAR-T cell therapy is one of the most promising areas of cancer research and treatment. Using this approach, immune cells are taken from a patient’s bloodstream, reprogrammed to recognize and attack a specific protein found in cancer cells, then reintroduced into the patient’s system, where they get to work destroying targeted tumor cells.
With axicabtagene ciloleucel, a Kite Pharma therapy, 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.
“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.”
CAR-T Expertise at City of Hope
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. The institution 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., with survival rates exceeding expectations for 12 consecutive years. 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 together account 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.
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.