On December 3, 2018 Kite, a Gilead Company (Nasdaq: GILD), reported its updated results from ZUMA-3, a single-arm Phase 1/2 study evaluating KTE-X19 (formerly KTE-C19), an investigational CD19 chimeric antigen receptor T (CAR T) cell therapy, in adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL) (Press release, Kite Pharma, DEC 3, 2018, View Source [SID1234531849]). With a median follow-up of 15.1 months (range 3.7 – 28.6 months) following a single infusion of KTE-X19, 69 percent of evaluable patients (n=25/36) achieved complete tumor remission, defined as complete remission (CR) or CR with incomplete hematological recovery (CRi). The rate of undetectable minimal residual disease (MRD) in patients who achieved complete tumor remission was 100 percent. Detailed results from this ongoing study were presented today at the Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) (ASH; Abstract #897).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are encouraged by the high number of patients who achieved complete leukemia remission following a single KTE-X19 infusion on this trial," said William G. Wierda, MD, PhD, Executive Medical Director and Professor, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. "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."

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 percent (n=10/44) 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.

"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," said Alessandro Riva, MD, Executive Vice President, Oncology Therapeutics and Head, Cell Therapy, Gilead Sciences. "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."

KTE-X19 is an investigational agent that has not been approved for any uses. Efficacy and safety have not been established.

About ALL

ALL is an aggressive type of blood cancer which can also involve the lymph nodes, spleen, liver, central nervous system and other organs.

About ZUMA-3

ZUMA-3 is an ongoing multicenter, registrational Phase 1/2 study in adult patients (≥18) 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.