A recent announcement by Gilead Company citing data from Kite Pharma, one of its premier companies, set out remarkable results from Kite’s Zuma-1 clinical trial.
The findings confirmed that Large B-cell refractory (treatment-resistant) lymphoma patients responded favorably after only one infusion of Yescarta® (axicabtagene ciloleucel).
About Large B cell lymphoma (LBCL)
LBCL is cancer found in white blood cells called lymphocytes. It generally affects older adults and is a common subtype of Non-Hodgkin lymphoma. Refractory LBCL is responsible for a major portion of LBCL mortalities. Current treatment consists of high-dose chemotherapy with SCT (stem cell transplants).
Therefore, the emergence of CAR T-cell personalized therapy has been well received.
About the Trial
The Zuma-1 Phase 2 trial enrolled 111 patients. The enrolled patients had previously received two or more systemic therapies. Systemic therapy is a form of therapy that travels through the bloodstream reaching cells throughout the body.
Upon further evaluation, one hundred and one LBCL patients were selected to receive one infusion of Yescarta, a CAR T-cell therapy. The median length of time for a complete response for these patients was under two months and it included eighty-seven percent of the participants. The trial, therefore, met its primary endpoint.
It is noteworthy that to date no secondary malignancies were reported related to Yescarta.
The overall survival rate in the fourth year was forty-four percent.
Dr. Frederick Locke, Co-Lead Principal Investigator, commented that the overall survival rate bodes well for the continued administration of CAR T-cell therapy where there have been no other viable options.
Dr. Ken Takeshita, Global Head of Kite’s Clinical Development, added that thousands of patients have been treated with Yescarta since it was first approved and again the trend has been towards long-term survival.
Dr. Takeshita said that the encouraging results from the Zuma-1 trial gave researchers the incentive to test the potential of CAR T-cell therapy in other hematological diseases.
About CAR T-cell Therapy
The FDA approved Yescarta in 2017. The therapy involves collecting T-cells from patients and genetically modifying the T-cells so that they will target specific proteins. The cells are then re-infused into the patient.
Yescarta has been approved with a risk evaluation. The U.S. prescribing information and BOXED WARNING regarding cytokine release syndrome, NEUROLOGIC TOXICITIES, and other adverse reactions may be found HERE.
About Kite
Kite is a Gilead company headquartered in Santa Monica. The biopharmaceutical company has facilities in Europe and North America. Kite’s main focus is developing innovative immunotherapy treatments for cancer.
About Gilead Sciences, Inc.
Gilead Sciences, with facilities in thirty-five countries, is research-based. The company focuses on the discovery, development, and commercialization of medicines for people with rare diseases where no viable treatments exist.
