By a News Reporter-Staff News Editor at Clinical Trials Week -- Kite Pharma, Inc. (Kite), a clinical-stage biotechnology company focused on engineered autologous T cell therapy (eACT) products for cancer, announced positive clinical data demonstrating that Kite's most advanced product candidate can produce robust and durable tumor shrinkage in patients with an aggressive form of non-Hodgkin's lymphoma. In an oral presentation at the 55th ASH Annual Meeting, James N. Kochenderfer, MD, from the NCI reported that an infusion of patients' own genetically modified T lymphocytes resulted in six complete remissions (CR) and six partial remissions (PR) among 13 patients with advanced B-cell malignancies who were eligible for response assessment (see also Kite Pharma, Inc.).
Kite Pharma and the Surgery Branch of the NCI, led by Steven A. Rosenberg, MD, PhD, are collaborating under a Cooperative Research and Development Agreement (CRADA) for the development and commercialization of novel eACT products for the treatment of multiple cancer indications. This technology utilizes patients' peripheral blood T lymphocytes genetically engineered with either chimeric antigen receptors (CAR) or T cell receptors (TCR) that recognize tumor-specific molecules, traffic directly to the tumor, become activated upon engagement with the tumor antigen, and selectively eradicate tumors. The reported Phase 1/2a clinical trial is being conducted at the NCI with Dr. Rosenberg serving as principal investigator.
In the clinical trial, patients' T cells were modified to express a CAR targeting the B cell antigen CD19. Among the nine patients with either chemotherapy-refractory primary mediastinal B cell lymphoma (PMBCL) or diffuse large B cell lymphoma (DLBCL), seven patients were evaluable for response. Of these seven patients, six showed a response (three CR's and three PR's). This is the first report of successful treatment of these patients with CD19 CAR T cells. The majority of clinical responses were durable (up to 22 months ongoing). Acute toxicities, including fever, low blood pressure, focal neurological deficits, and delirium occurred in some patients after cell infusion, but resolved in less than three weeks.
"These clinical results are extremely encouraging and further validate both the CD19 target and the overall eACT approach," said Keith Nolop, MD, Chief Medical Officer of Kite Pharma. "These patients have aggressive disease that is resistant to chemotherapy, and they have no viable treatment options other than a clinical trial. Both the high overall response rate and the durability of the responses are noteworthy."
Arie Belldegrun, MD, Founder and Executive Chairman of the Board of Kite Pharma, added, "Our collaboration with the NCI has been highly productive and rewarding. Given the dramatic responses achieved so far, Kite is fully committed to rapidly advance the clinical development of the CAR technology for multiple indications. We look forward to bringing this promising therapy to patients with advanced cancer."
Keywords for this news article include: Drugs, Cancer, Genetics, Oncology, Treatment, Immunology, Technology, Blood Cells, CD Antigens, Engineering, Chemotherapy, CD19 Antigens, T-Lymphocytes, Blood Proteins, Differentiation, Immunoglobulins, B-Cell Receptors, Kite Pharma Inc., Biological Factors, B-Lymphocyte Antigens, Mononuclear Leukocytes.
Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2013, NewsRx LLC