Kite Announces New Data Analyses for CAR T Therapy in Patients with Blood Cancers at the 2018 American Society of Clinical Oncology Meeting

-- ZUMA-1 Data Suggest Patient Response to Yescarta® (axicabtagene ciloleucel) at Three Months May be Predictive of Longer-Term Response in Refractory B-cell Lymphoma --

-- ZUMA-3 Analysis Suggests High Complete Response Rates with KTE-C19 in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) Regardless of Prior Blinatumomab Treatment --

CHICAGO--(BUSINESS WIRE)--Kite, a Gilead Company (Nasdaq: GILD), today announced new analyses from the ZUMA chimeric antigen receptor T (CAR T) cell therapy development program that are being presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The results include analyses of the ZUMA-1 study of Yescarta® (axicabtagene ciloleucel) in adult patients with refractory large B-cell lymphoma showing that response status may predict rates of progression-free survival (PFS) (Abstract #3003) and that treatment responses were consistent across prior lines of therapy (Abstract #3039). Additionally, an analysis of the ZUMA-3 study evaluating investigational KTE-C19 for the treatment of adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL) showed that patients experienced manageable safety and encouraging efficacy irrespective of prior blinatumomab use (Abstract #7006).

“With the U.S. approval of Yescarta last year, we aim to transform the treatment of patients with refractory large B-cell lymphoma,” said Alessandro Riva, MD, Gilead’s Executive Vice President, Oncology Therapeutics & Head, Cell Therapy. “We are also committed to studying Yescarta and other CD19-directed CAR T therapies for people with other relapsed or refractory blood cancers. Based on the strength of the ZUMA-1 data, we are now evaluating the potential of Yescarta in the second-line treatment setting in a Phase 3 study, ZUMA-7, and we continue to evaluate KTE-C19 in Phase 1/2 studies in ALL and other hematologic cancers.”

Yescarta was the first CAR T cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.

Yescarta has a Boxed Warning in its product label and an associated Risk Evaluation and Mitigation Strategy (REMS) regarding the risks of CRS and neurologic toxicities. Please see below for Important Safety Information.

A Marketing Authorization Application (MAA) for axicabtagene ciloleucel is currently under review with the European Medicines Agency (EMA).

Ongoing Responses, Response by Prior Lines of Therapy in ZUMA-1 (Abstracts #3003 and #3039)

Long-term ZUMA-1 follow-up data have shown an overall response rate (ORR) of 83 percent (n=84/101), including 58 percent (n=59/101) of patients with a complete response at a median follow-up of 15.1 months. In this long-term follow-up, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were seen in 12 percent and 29 percent of patients, respectively.

A new analysis of ZUMA-1 suggests that response status three months after infusion of Yescarta may be predictive of longer-term disease control. Of the 42 patients with complete response and nine with partial response at three months, the 12-month PFS rates were 79 percent and 78 percent, respectively. This abstract has also been selected for inclusion in the 2018 Best of ASCO® program.

“We are encouraged by the strong long-term complete response rates in ZUMA-1, which represents a patient population that previously had few if any remaining treatment options,” said Frederick L. Locke, MD, ZUMA-1 Co-Lead Investigator and Vice Chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy at Moffitt Cancer Center in Tampa, Florida. “Importantly, this new study analysis indicates that response status at three months is potentially predictive of prolonged PFS.”

An additional ZUMA-1 analysis evaluated outcomes based on prior therapy the patients had received. The results indicate long-term clinical benefit for patients with refractory large B cell lymphoma, irrespective of the number of prior lines of therapy.

Rates of Response with Prior Blinatumomab Treatment in ZUMA-3 (Abstract #7006)

Phase 1 data for KTE-C19, an investigational CD19 CAR T cell therapy, presented at the 2017 Annual Meeting of the American Society of Hematology (ASH) demonstrated high rates of complete response in adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL). A new analysis of data from the ZUMA-3 study shows patients responded to KTE-C19 regardless of prior treatment with blinatumomab, an FDA-approved treatment for relapsed or refractory ALL. After eight or more weeks of follow-up, 63 percent (n=5/8) of patients with prior blinatumomab treatment and 80 percent (n=8/10) of patients without prior blinatumomab treatment had achieved a complete response or complete response with incomplete hematological recovery. Overall, 94 percent (n=17/18) of patients had minimal residual disease (MRD)-negative remission. KTE-C19 was also manufactured successfully in both groups, with similar product characteristics in terms of CD4/CD8 ratio and other measures.

“As a CD19/CD3 bispecific T cell antibody, the possible impact of prior blinatumomab use on the efficacy of KTE-C19 – a CD19-directed CAR T therapy – was an important question for exploration,” said Bijal Shah, MD, ZUMA-3 investigator and medical oncologist, Moffitt Cancer Center. “We observed that prior blinatumomab use did not affect the manufacturing of efficacious product, and that high response rates were seen regardless of previous treatment with blinatumomab.”

Grade 3 or higher CRS was seen in 27 percent of patients with prior blinatumomab and in 17 percent of patients without prior blinatumomab. Grade 3 or higher neurologic events were seen in 36 percent of patients with prior blinatumomab and 67 percent of patients without prior blinatumomab. A greater number of subjects in the blinatumomab-naïve group received the higher 1 × 106 cells/kg dose.

KTE-C19 for ALL is investigational and has not been proven safe or efficacious.

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: Gilead Sciences

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