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--  If approved, autologous anti-CD19-transduced CD3+ cells (formerly KTE-X19, Tecartus®) may become available for use in adult patients with relapsed or refractory B cell precursor acute lymphoblastic leukaemia –


Stockley Park, UK – 24 June 2021 – Kite, a Gilead Company, today announced that the company’s Type II variation application for a new indication to the approved license for autologous anti-CD19-transduced CD3+ cells has been validated, and is now under evaluation by the European Medicines Agency (EMA). The proposed indication is for the treatment in adult patients (over 18 years of age) with relapsed or refractory B cell precursor acute lymphoblastic leukaemia (aALL).


“ALL is a notoriously difficult blood cancer to treat in adults who have poor survival outcomes and limited treatment options when compared with children typically diagnosed with the disease,” said Dick Sundh, Head of Australia Canada and Europe, Kite. “We are working closely with the regulatory authorities to progress our application to potentially bring the benefits of CAR T cell therapy to adult patients in Europe, with anticipated approval in 2022.”


The Type II variation is supported by data from the pivotal global, single-arm ZUMA-3 trial for adults with relapsed or refractory B-ALL (n=55). At a median follow-up of 16.4 months, 71% of treated patients achieved a complete response (CR) or CR with incomplete haematological recovery (CRi), with 31% in ongoing response at data cut-off.[i] Grade ≥3 adverse events occurred in 95% of patients, with anaemia (49%) and pyrexia (36%) most frequently reported. Grade ≥3 cytokine release syndrome (CRS) and neurologic events occurred in 24% and 25% of patients, respectively, and were generally reversed with treatment.1 Detailed findings from this trial were presented in June 2021 at the Annual Meeting of the European Hematology Association,1 and published in The Lancet.2


The use of autologous anti-CD19-transduced CD3+ cells for the treatment of adult patients with relapsed or refractory B-ALL remains investigational in Europe.






About Acute Lymphoblastic Leukaemia

Acute lymphoblastic leukaemia (ALL) is an aggressive blood cancer which can also involve the lymph nodes, spleen, liver, central nervous system, and other organs. Globally over 64,000 people are diagnosed with ALL each year.3 While ALL incidence rates are four times higher in children than adults, survival is particularly poor among adults.4


About ZUMA-3 

ZUMA-3 is an ongoing international multicentre registrational Phase 1/2 study in adult patients (≥18 years old) with B-ALL whose disease is refractory to or has relapsed following standard systemic therapy with remission of 12 months or less, after two or more lines of systemic therapy or after allogeneic stem cell transplantation. The objectives of the study are to evaluate the safety and efficacy of autologous anti-CD19-transduced CD3+ cells in this patient population.1 


About Kite’s Autologous Anti-CD19-transduced CD3+ Cells (Formerly KTE-X19)

In December 2020, the European Commission granted conditional Marketing Authorisation for autologous anti-CD19-transduced CD3+ cells, the first CAR T cell therapy approved in Europe for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.5


About Kite 

Kite, a Gilead Company, is a global 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 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.


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 ongoing and additional clinical studies. 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 31 March 2021, 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.


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Last Updated: 24-Jun-2021