Gilead’s company Kite’s trial for KTE-X19, its chimeric antigen receptor T cell therapy for adults with ALL (leukemia), resulted in high number of patients getting complete leukemia remission after a single infusion.
The company said Mondy that the results from ZUMA-3, a single-arm Phase 1/2 study evaluating KTE-X19, an investigational CD19 CAR T cell therapy, for adults with relapsed or refractory acute lymphoblastic leukemia (ALL), 69%of evaluable patients achieved complete tumor remission, defined as complete remission (CR) or CR with incomplete hematological recovery (CRi).
William G. Wierda, Executive Medical director department of Leukemia at the university of Texas MD Anderson Cancer Center, said it is encouraging to have a high number of patients who achieved complete leukemia remission after a single KTE-X19 infusion on the trial. “In relapsed and refractory ALL, where the majority of adult patients have poor response to treatment and short remissions and survival, these findings give optimism for improving outcomes and potentially showing clinical benefit for those affected by ALL,” he said.
Kite said that adverse events were consistent with the known toxicities of CD19 CAR T treatment, including Grade 3 or higher cytokine release syndrome (CRS) and neurologic events in 23% and 39 percent (n=17/44) of patients, respectively. The majority of these adverse events were resolved, with the exception of two patients who had ongoing neurological events at the time of death from other causes. Two patients died from adverse events deemed by the treating investigator to be related to KTE-X19, Kite said.
Alessandro Riva, Executive Vice President, Oncology Therapeutics and Head, Cell Therapy, Gilead Sciences, said: “These updated results from ZUMA-3 provide continued support for the potential of our CD19-directed CAR T therapies in new types of cancers and reinforce our leadership in cell therapy. Based on these findings, we have initiated Phase 2 of the study evaluating KTE-X19 in a larger set of adult patients with ALL who are in need of new treatment options.”