KITE’S CAR T-CELL THERAPY TECARTUS® (BREXUCABTAGENE AUTOLEUCEL) GRANTED EUROPEAN MARKETING AUTHORISATION FOR THE TREATMENT OF RELAPSED OR REFRACTORY ACUTE LYMPHOBLASTIC LEUKAEMIA (r/r ALL)

KITE’S  CAR  T-CELL  THERAPY  TECARTUS^®  (BREXUCABTAGENE  AUTOLEUCEL)  GRANTED EUROPEAN MARKETING AUTHORISATION FOR THE TREATMENT OF  RELAPSED  OR  REFRACTORY  ACUTE  LYMPHOBLASTIC  LEUKAEMIA  (r/r ALL)

-- Approval Marks Kite’s Fourth Indication in Europe for its Two Cell Therapies and First in Leukaemia --

-- Overall Complete Remission of 71% and a Median Overall Survival of More Than Two Years for All Patients and Almost Four Years for Responders Demonstrated in ZUMA-3 Trial --

Stockley Park, UK – 7 September 2022 – Kite, a Gilead Company, today announced that the European Commission (EC) has approved its CAR T-cell therapy Tecartus^® (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukaemia (ALL).

“This approval makes brexucabtagene autoleucel the first and only CAR T-cell therapy indicated for this population of patients, addressing a significant unmet medical need,” said Christi Shaw, CEO, Kite. “This is also the fourth indication in Europe for which a Kite cell therapy is approved, clearly demonstrating the benefits they offer to patients, especially those with limited treatment options.”

ALL is an aggressive type of blood cancer; the most common form is B cell precursor ALL.[1] Globally, approximately 64,000 people are diagnosed with ALL each year.[2]^,[3]  Half of adults living with ALL will relapse, and median overall survival (OS) with current standard-of-care treatments is approximately just eight months.[4]^,[5]

“Adults with relapsed or refractory ALL often undergo multiple treatments including chemotherapy, targeted therapy and stem cell transplant, creating a significant burden on a patient’s quality of life,” said Max S. Topp, MD, professor and head of Hematology, University Hospital of Wuerzburg, Germany. “Patients in Europe now have a meaningful advancement in treatment. Tecartus has demonstrated durable responses, suggesting the potential for long-term remission and a new approach to care.”

The approval is supported by data from the ZUMA-3 international multicentre, single-arm, open-label, registrational Phase 1/2 study of adult patients (≥18 years old) with relapsed or refractory ALL. This study demonstrated that 71% of the evaluable patients (n=55) achieved complete remission (CR) or CR with incomplete haematological recovery (CRi) with a median follow-up of 26.8 months.[6] In an extended data set of all pivotal dosed patients (n=78) the median overall survival for all patients was more than two years (25.4 months) and almost four years (47 months) for responders (patients who achieved CR or CRi).^6,[7] Among efficacy-evaluable patients, median duration of remission (DOR) was 18.6 months.⁶

Among the patients treated with brexucabtagene autoleucel at the target dose (n=100) safety results were consistent with the known safety profile for brexucabtagene autoleucel. Grade 3 or higher cytokine release syndrome (CRS) and neurologic adverse reactions occurred in 25% and 32% of patients, respectively, and were generally well managed. ^[8],[9]^,[10] 

[1] Leukaemia Care. B-cell Acute Lymphoblastic Leukaemia (ALL). Available at: https://media.leukaemiacare.org.uk/wp-content/uploads/B-cell-Acute-Lymphoblastic-Leukaemia-ALLWeb-Version.pdf. Accessed September 2022.

[2] Dong, Y, et al. Leukemia incidence trends at the global, regional, and national level between 1990 and 2017. Exp Hematol Oncol 9, 14 (2020). https://doi.org/10.1186/s40164-020-00170-6. Accessed September 2022.

[3] Leukemia and lymphoma Society Canada. Facts and Statistics. About Blood Cancers. Available at: https://www.llscanada.org/disease-information/facts-and-statistics#Leukemia. Accessed September 2022.

[4] Kantarjian H, et al. Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia. N Engl J Med (2017) 376: 836-847.

[5] Kantarjian H, et al. Inotuzumab Ozogamicin Versus Standard of Care in Relapsed or Refractory Acute Lymphoblastic Leukemia: Final Report and Long-Term Survival Follow-Up From the Randomized, Phase 3 INO-VATE Study. Cancer (2019) 125(14):2474-2487.

[6] Bijal D, et al. Two-year follow-up of KTE-X19, an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, in adult patients (Pts) with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) in ZUMA-3. Journal of Clinical Oncology (2022) 40:16_suppl, 7010-7010.

[7] Data on file. Figure 14.2.10.8.9. Kaplan-Meier Plot of Overall Survival with CR+CRi vs. Others using Independent Review (Phase 1, 1e6 Dose Level and Phase 2, Safety Analysis Set)

[8] Data on file. Table 14.3.2.31.8. Ad-hoc: Subject Incidence of Treatment-emergent Cytokine Release Syndrome Adverse Events by Preferred Term and Worst Grade (ZUMA-2 and ZUMA-3) (Safety Analysis Set)

[9] Data on file. Table 14.3.2.31.10. Ad-hoc: Subject Incidence of Treatment-emergent Neurologic Events by Preferred Term and Worst Grade - Method 1 (ZUMA-2 and ZUMA-3) (Safety Analysis Set)

[10] European Medicines Agency. Tecartus® (autologous anti-CD19-transduced CD3+ cells) SPC. Available at: https://www.ema.europa.eu/en/documents/product-information/tecartus-epar-product-information_en.pdf.  Accessed September 2022.