NEW EUROPEAN ANALYSIS REINFORCES 19 DAY COMMERCIAL MANUFACTURING TURNAROUND TIME FOR YESCARTA® (AXICABTAGENE CILOLEUCEL) FOR ADULT PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA

Stockley Park, UK – 24 April 2023 – Kite, a Gilead Company, today announces the publication of a new European analysis of commercial manufacturing experience of Yescarta^® (axicabtagene ciloleucel or axi-cel) that shows a median European manufacturing turnaround time of 19 days for patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).¹  These findings (poster #P198 link) were presented today at the 2023 Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT), in Paris, France.

The analysis includes data from 2,432 European patients with R/R DLBCL who underwent leukapheresis (the collection of a patient’s white blood cells) and who received commercial axicabtagene ciloleucel between 6 September 2020 and 5 September 2022 with patient lots delivered to treatment centres across the European Union, the United Kingdom, Switzerland, and Israel and was compared to data from 1,115 European patients who underwent leukapheresis between 6 September 2018 and 5 September 2020.²

“This new analysis reinforces our global manufacturing turnaround time data, and the consistency of our delivery success rates. Research shows manufacturing turnaround times may be associated with better patient outcomes. That is why manufacturing is a key consideration with every decision we make at Kite. As the global leader in cell therapy, it’s important that we understand all of the factors that can contribute to the best possible outcomes for patients,” said Chris McDonald, Global Head of Technical Operations, Kite.

The new data also shows a reduced median manufacturing turnaround time of 19 days for European patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), compared to 25 days from the initial 2-year analysis in 2020. An improvement in delivery success rate since the initial 2-year period (99% vs 96%) was also observed. Additionally, the number of patients included in the latest 2-year analysis more than doubled.¹  Manufacturing turnaround time is defined as time from day of leukapheresis to the day of product disposition for lots using fresh apheresis material. Delivery success rate is defined as the percentage of patients for whom a dose was shipped out of the total number of patients leukapheresed in the time period (excluding those patient lots in process and patients withdrawn).

The analysis occurred across two sites in the Kite manufacturing network dedicated to the production of CAR T-cell therapy, in the United States (California) and the Netherlands. Kite has invested in additional manufacturing capacity and capability, with a third facility in Maryland, USA, receiving approval from the US Food and Drug Administration (FDA) in April 2022. 

About Axicabtagene Ciloleucel

In October 2022, axicabtagene ciloleucel, a chimeric antigen receptor (CAR) T cell therapy, was approved by the European Commission (EC) for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) who relapse within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. ³ In June 2022, axicabtagene ciloleucel was approved by the EC for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy. In August 2018, axicabtagene ciloleucel was approved by the EC for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy.³

About Diffuse Large B-Cell Lymphoma (DLBCL)

Diffuse large B-cell lymphoma (DLBCL) is the most common sub-type of non-Hodgkin lymphoma (NHL), representing around 31% of cases.⁴ In Europe it is estimated that up to 38,000 new cases of DLBCL were diagnosed in 2020.⁵ Although first-line treatment can be effective in around 60% of cases, up to half of these will relapse (return).^6,7 For people who relapse, or who do not respond to first-line treatment, outcomes are often poor.⁶ Most patients with refractory (no response) LBCL have no curative treatment options.⁸

About Kite 

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on cell therapy to treat and potentially cure cancer.  As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company.  Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production and commercial product manufacturing.

About Gilead Sciences 

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Gilead Sciences acquired Kite in 2017.

Forward-Looking Statements

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 unfavourable results from ongoing or additional clinical trials involving axicabtagene ciloleucel; Kite’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, including those involving axicabtagene ciloleucel; Kite’s ability to receive regulatory approvals in a timely manner or at all, including additional regulatory approvals of axicabtagene ciloleucel, and the risk that any such approvals may be subject to significant limitations on use; the risk that physicians may not see the benefits of prescribing axicabtagene ciloleucel; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Annual Report on Form 10-K for the year ended 31 December 2022, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Kite and Gilead, and Kite and Gilead assume no obligation and disclaim any intent to update any such forward-looking statements.