NEW FOUR-YEAR DATA SHOW LONG-TERM SURVIVAL IN PATIENTS WITH RELAPSED/REFRACTORY LARGE B CELL LYMPHOMA TREATED WITH YESCARTA® (AXICABTAGENE CILOLEUCEL) IN ZUMA-1 TRIAL
-- 44% Estimated Four-Year Overall Survival Rate Among Relapsed/Refractory Large B cell Lymphoma Patients After a Single Infusion of Axicabtagene Ciloleucel --
Stockley Park, UK – 5 December 2020 – Kite, a Gilead Company, today announced four-year follow up data from the pivotal ZUMA-1 trial of Yescarta® (axicabtagene ciloleucel) in adult patients with relapsed/refractory large B cell lymphoma (LBCL). Among axicabtagene ciloleucel-treated patients (modified intent to-treat analysis, n=101) with a minimum follow-up of four years after a single infusion of axicabtagene ciloleucel (median follow-up of 51.1 months), the Kaplan-Meier estimate of the four-year overall survival (OS) rate was 44%. The data were presented today at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract #1187).1
Of 111 patients enrolled in the ZUMA-1 Phase 2 cohorts, axicabtagene ciloleucel was administered to 101 patients with relapsed/refractory LBCL, and the median time from leukapheresis to complete response (CR) was less than two months. There have been no axicabtagene ciloleucel-related secondary malignancies reported.
“With 44% of patients still alive after a single infusion of axicabtagene ciloleucel, we are transforming the way relapsed/refractory large B cell lymphoma can be treated,” 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. “As a practicing oncologist I continue to see these patients in the clinic, and this overall survival data confirms the durability of CAR T cell therapy in a patient population that previously exhausted all viable treatment options.”
Blood sample analyses provided by 21 patients who were treated with axicabtagene ciloleucel and showed an ongoing response at a minimum of three years follow-up also demonstrated that 67% (n=14/21) had detectable CAR gene-marked cells and polyclonal B cells in blood. Additionally, normal B cells were present in 91% (n=21/23) of evaluable patients. These results suggest that persistence of functional CAR T cells is not necessary for durable remissions in patients with relapsed/refractory LBCL and may support long-term safety of the therapy.
“With these first-ever four-year data from a pivotal CAR T clinical trial in lymphoma, we continue to show the potential long-term survival of axicabtagene ciloleucel in relapsed/refractory large B cell lymphoma and transform our understanding of what is possible with this CAR T treatment,” said Ken Takeshita, MD, Kite’s Global Head of Clinical Development. “And of equal importance, we are encouraged by similar trends in real world experience, with thousands of patients treated since axicabtagene ciloleucel first became commercially available.”
About Axicabtagene Ciloleucel
Axicabtagene ciloleucel is a CD19-directed genetically modified autologous T cell immunotherapy. In August 2018, axicabtagene ciloleucel, a chimeric antigen receptor (CAR) T cell therapy, received European Marketing Authorisation for the treatment of adult patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL) and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy.2
Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California, with commercial manufacturing operations in North America and Europe. 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.
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 risk that physicians and patients may not see the potential benefits of Yescarta therapy and the possibility of unfavorable results from other ongoing and additional clinical studies 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, 2020, 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.
Kite, the Kite logo, Yescarta and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.
1 Jacobson, et al. Long-Term Survival and Gradual Recovery of B Cells in Patients With Refractory Large B Cell Lymphoma Treated With Axicabtagene Ciloleucel (Axi-Cel). Abstract #1187 (Poster) presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.
2 European Medicines Agency. Yescarta® (axicabtagene ciloleucel) SmPC. Available at: https://www.ema.europa.eu/documents/product-information/yescarta-epar-product-information_en.pdf. Accessed December 2020.
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IHQ-ONC-2020-11-0003 December 2020