Kite Announces Updated Data From ZUMA-3 Study of KTE-X19 in Adult Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

-- Ongoing Phase 1/2 Study Continues to Demonstrate High Rates of Response to a Single Infusion of KTE-X19 in a Patient Population with Limited Treatment Options --

-- Based on these Data, the Phase 2 Portion of ZUMA-3 is Now Enrolling --

-- Findings Presented in an Oral Session at the Annual Meeting of the American Society of Hematology (ASH) --

SAN DIEGO, CA, USA I December 03, 2018 I Kite, a Gilead Company (Nasdaq: GILD), announced 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). 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; Abstract #897).

“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.

About Kite

Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies. For more information on Kite, please visit www.kitepharma.com.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.

SOURCE: Kite Pharma

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