June 01, 2019
-- Data Show High Rates of Response to Single Infusion of KTE-X19 --
-- Phase 2 Portion of ZUMA-3 is Ongoing and Includes Dosing and Revised Safety Management Protocol Studied in Phase 1 --
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By the end of Phase 1, 45 patients received KTE-X19 at one of three different doses levels [2 x 106 cells/kg (n=6), 1 x 106 cells/kg (n=23), or 0.5 x 106 cells/kg (n=16)]. Patients enrolled in this study were primary refractory or relapsed/refractory after at least two prior lines of therapy. Of 41 patients who were evaluable for efficacy after a minimum two months of follow-up (median follow-up of 16 months), 68 percent achieved complete response (CR) or CR with incomplete hematological recovery (CRi) and 100 percent of responders had undetectable minimal residual disease (MRD). Of the 23 patients treated with the dose level that will be used in the ongoing Phase 2 study (1 x 106 cells/kg), 19 were evaluable for efficacy. At the time of data cut-off (median duration of remission = 12.9 months), 16 (84 percent) patients achieved CR or CRi, and 12 patients (75 percent) were in ongoing response.
No dose-limiting toxicities (DLTs) were identified. Grade ≥3 cytokine release syndrome (CRS) events and neurologic events occurred in 29 percent and 38 percent of all patients, respectively. As previously reported, two patients experienced KTE-X19–related Grade 5 adverse events (AEs) during the study; one developed stroke in the context of CRS and neurologic events, and one experienced multiorgan failure secondary to CRS. Among patients receiving 1 x 106 cell/kg (n=23), 26 percent experienced Grade ≥3 CRS, and 43 percent experienced Grade ≥3 neurologic events.
A revised AE management protocol was implemented in nine patients treated with 1 x106 cells/kg of KTE-X19 during the study. In this revised protocol, corticosteroids were initiated at onset of Grade ≥2 neurologic events (versus previous onset of Grade 3) and tocilizumab was only given for management of toxicities in the context of CRS (versus prophylactic administration in Cohort 2). Of those patients, two (22 percent) had Grade 3 CRS and one (11 percent) had Grade 3 neurologic events. There were no Grade 4/5 events.
“Adults with relapsed or refractory ALL represent an extremely
difficult-to-treat patient population,” said
“The completion of the Phase 1 portion of the ZUMA-3 trial is an
important milestone for our second investigational CAR T cell therapy,”
This abstract has also been selected to be included in the 2019 Best of
KTE-X19 is an investigational therapy that has not been approved by the
ALL is an aggressive type of blood cancer which can also involve the lymph nodes, spleen, liver, central nervous system and other organs.
ZUMA-3 is an ongoing multicenter, registrational Phase 1/2 study in adult patients (≥18 years old) with ALL whose disease is refractory to or has relapsed following standard chemotherapy or hematopoietic stem cell transplantation. The objectives of the study are to evaluate the safety and efficacy of KTE-X19 in this patient population.
KTE-X19 is an investigational CD19 CAR T cell therapy. KTE-X19 has the same construct as axicabtagene ciloleucel; however, the manufacturing process for KTE-X19 differs from that of axicabtagene ciloleucel and includes the enrichment of lymphocytes. Lymphocyte enrichment is necessary in certain B-cell malignancies for which KTE-X19 in under investigation. KTE-X19 is currently in Phase 1/2 trials in acute lymphoblastic leukemia (ALL), mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).
This press release includes forward-looking statements, within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including Kite’s
ability to complete Phase 2 of the ZUMA-3 study of KTE-X19 in adult
patients with relapsed or refractory acute lymphoblastic leukemia in the
currently anticipated timelines, or at all. In addition, there is the
possibility of unfavorable results from other ongoing and additional
clinical trials involving KTE-X19. Further, Kite may be unable to obtain
regulatory approval for KTE-X19 from the
For more information on Kite, please visit the company’s website at www.kitepharma.com. Learn more about Gilead at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-300
Source: Kite, a
Sung Lee, Investors
Nathan Kaiser, Media