KITE, A GILEAD COMPANY, ANNOUNCES LONG-TERM DATA FROM ZUMA-1 SHOWING 47% OF RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA PATIENTS WERE ALIVE THREE YEARS AFTER YESCARTA® (AXICABTAGENE CILOLEUCEL) TREATMENT

Approximately half (47 Percent) of Relapsed/Refractory Large B-cell Lymphoma Patients in ZUMA-1 Pivotal Phase 2 Cohorts Were Alive Three Years after a Single Infusion of axicabtagene ciloleucel

Orlando, December 7, 2019 -- Kite, a Gilead Company (Nasdaq: GILD), today announced new data from the pivotal ZUMA-1 trial of Yescarta^® (axicabtagene ciloleucel) which showed that approximately half (n=47/101; 47 percent) of patients with relapsed/refractory large B-cell lymphoma were alive after three years.(1). The data were presented today at the 61^st American Society of Hematology (ASH) Annual Meeting & Exposition, in Orlando from December 7–10, 2019. 

With a minimum follow-up of more than three years after a single infusion of axicabtagene ciloleucel (median follow-up of 39.1 months), approximately half (n=47/101; 47 percent) of patients with relapsed/refractory large B-cell lymphoma in the ZUMA-1 pivotal Phase 2 cohorts were alive, and the median overall survival (OS) was 25.8 months. These updated three-year survival data were presented as part of a ZUMA-1 analysis evaluating the mechanism of secondary treatment failure following treatment with axicabtagene ciloleucel (Abstract #203). (1)

“With approximately half of patients with relapsed/refractory large B-cell lymphoma in our registrational trial alive three years following treatment with axicabtagene ciloleucel, we are delivering towards our goal of potentially life-saving therapy for many patients who previously faced limited treatment options and a poor prognosis prior, to the introduction of CAR T cell therapy, further supporting our ongoing leadership in cell therapy and commitment to patient care.” said Christi Shaw, Chief Executive Officer of Kite.

On 23 August 2018, axicabtagene ciloleucel received European Marketing Authorisation for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma, after two or more lines of systemic therapy. (2)

In addition, updated results from a separate ZUMA-1 safety management study (Cohort 4) were also presented at the meeting (Abstract #243).(3) In this analysis, patients with relapsed or refractory large B-cell lymphoma treated with axicabtagene ciloleucel received earlier steroid intervention, beginning when patients experienced Grade 1 neurologic events or experienced Grade 1 CRS, when no improvement was observed after three days of supportive care. In addition, patients were allowed to receive optional bridging chemotherapy prior to infusion with axicabtagene ciloleucel.

In the analysis, 41 patients had received axicabtagene ciloleucel, with a median follow-up of 8.7 months; 73 percent of patients received corticosteroids and 76 percent received tocilizumab. Earlier steroid use appeared to decrease the percentage of patients with Grade ≥3 CRS (2 percent) and neurologic events (17 percent), each of which were numerically lower than rates in the registrational cohorts of ZUMA-1 (13 percent Grade ≥3 CRS, 31 percent Grade ≥3 neurologic events). Additionally, there were no Grade 4 or 5 CRS or neurologic events and no Grade 5 AEs related to axicabtagene ciloleucel in Cohort 4.

Objective response rate per investigator assessment was 73 percent in Cohort 4, with 51 percent of patients achieving a complete response. The median follow-up was 8.9 months. Fifty-four percent of patients in this cohort remained in an ongoing response with at least six months of follow-up after infusion with axicabtagene ciloleucel. Median OS in Cohort 4 has not been reached.

“Results from ZUMA-1 Cohort 4 demonstrate that early steroid intervention has the potential to reduce the rate of severe CRS and neurologic events, while appearing to maintain comparable efficacy for axicabtagene ciloleucel to the pivotal ZUMA-1 study cohorts.” said Max S. Topp, MD, ZUMA-1 Cohort 4 investigator and Professor and Head of Hematology, University Hospital of Wuerzburg, Germany. “Data from this cohort suggest this approach with earlier steroid use may improve the benefit/risk profile of axicabtagene ciloleucel.”

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.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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.

Forward-Looking Statement

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 the possibility of unfavorable results from other ongoing and additional clinical trials involving Yescarta. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation to update any such forward-looking statements.

Full European Summary of Product Characteristics for Yescarta^® is available from the EMA website at www.ema.europa.eu. 

Yescarta is a registered trademark of Gilead Sciences, Inc., or its related companies.

References

1. Neelapu SS, et al. CD19-Loss with Preservation of Other B Cell Lineage Features in Patients with Large B Cell Lymphoma Who Relapsed Post–Axi-Cel. Abstract #203 (Oral) to be presented at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition.
2. European Medicines Agency. Yescarta (axicabtagene ciloleucel) SPC. Available at: https://www.ema.europa.eu/documents/product-information/yescarta-epar-product-information_en.pdf Accessed November 2018.
3. Topp M, et al. Earlier Steroid Use with Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory Large B Cell Lymphoma. Abstract #243 (Oral) to be presented at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition.