Kite’s CAR T-Cell Therapy Accepted for Use on the NHS in Scotland to Treat Aggressive Form of Blood Cancer

Kite’s CAR T-Cell Therapy Accepted for Use on the NHS in Scotland to Treat Aggressive Form of Blood Cancer

- First CAR T-cell therapy for adult (26+) patients with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL) reimbursed in Scotland -

Monday 9^th October 2023, London, UK – Gilead Sciences Ltd. today announced that the Scottish Medicines Consortium (SMC) has accepted the use of its Kite CAR T-cell therapy, Tecartus^®  (brexucabtagene autoleucel; brexu-cel), for the treatment of a rare and aggressive form of blood cancer.1 Brexu-cel is the first licensed CAR T-cell therapy for the treatment of adult patients (26 years of age and above) with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (r/r ALL).[1]

ALL is an aggressive type of blood cancer in which immature lymphocytes (a type of white blood cell) start multiplying uncontrollably, resulting in a rapid progression of the disease that can spread to a patient’s lymph nodes, spleen, liver, central nervous system and other organs.[2] To date, chemotherapy, stem-cell transplantation and targeted therapies have been the primary treatment options for r/r ALL and survival rates in adult patients are poor, with a median overall survival of less than eight months.[3]

CAR T-cell therapies are individually made starting from a patient’s own white blood cells, called T-cells. The cells are removed through a process similar to donating blood platelets or plasma and sent to specialised manufacturing facilities where they are engineered to find and destroy the patient’s cancer, expanded, and then returned to the hospital for infusion back into the patient.

“Gilead and Kite are proud to be leading the way in bringing CAR T-cell therapies to more blood cancer patients – we now have two therapies being used to treat multiple blood cancers in Scotland. ALL is an aggressive disease, and we would like to thank the SMC for recognising the urgent need for new cancer medicines with the aim to improve outcomes and giving people more time.” Dr Véronique Walsh, Vice President and General Manager, Gilead Sciences UK & Ireland.

NOTES TO EDITORS

About brexucabtagene autoleucel (brexu-cel)[4]

Brexu-cel is a CD19-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of:

• Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after two or more lines of systemic therapy including a Bruton's tyrosine kinase (BTK) inhibitor
• Adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL)

Data supporting the use of brexucabtagene autoleucel (brexu-cel)

Data supporting the use of brexu-cel in relapsed or refractory B-cell precursor ALL was reported in the pivotal ZUMA-3 single-arm trial. Within the combined Phase 1/2 data set in 63 patients 26 years old and above, 73% of the evaluable patients treated with brexu-cel achieved overall complete remission (with or without incomplete hematologic recovery), as determined by an independent review.[5] Adverse events of grade 3 or higher occurred in 76% of patients who received brexu-cel. Two grade 5 events were considered to be related to brexu-cel (brain herniation and septic shock).[3]

For full details on the Special Warnings and Precautions for Use and Adverse Reactions (including appropriate management) for brexu-cel, please refer to the GB Summary of Product Characteristics (SmPC).

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 supply and commercial product manufacturing.

About Gilead Sciences

Gilead Sciences 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.

[1] Scottish Medicines Consortium (SMC). Tecartus update SMC2548.

[2] Leukaemia Care. Acute Lymphoblastic Leukaemia. Available at: https://www.leukaemiacare.org.uk/support-and-information/information-about-blood-cancer/blood-cancer-information/leukaemia/acute-lymphoblastic-leukaemia/. Last accessed: October 2023. 

[3] Shah BD, Ghobadi A, Oluwole OO, et al. KTE-X19 for relapsed or refractory adult B-cell acute lymphoblastic leukaemia: phase 2 results of the single-arm, open-label, multicentre ZUMA-3 study. Lancet. 2021;398(10299):491-502.

[4] Tecartus. Summary of Product Characteristics. Updated February 2023. Available at: https://www.medicines.org.uk/emc/product/11987/smpc#gref. Last accessed: October 2023.

[5] Data on file.