Kite reports positive three-year results for CAR T-cell therapy in rare blood cancer

Kite, a Gilead company, has reported positive three-year follow-up results from an ongoing study of its CAR T-cell therapy Tecartus (brexucabtagene autoleucel) in relapsed/refractory B-cell acute lymphoblastic leukaemia (R/R B-ALL), an aggressive and rare type of blood cancer.

Around 790 people are diagnosed with ALL each year in the UK and, while 80% of cases occur in children, it represents a devastating disease in adults.

B-ALL is the most common form of the disease in adult patients and, for those whose disease is refractory to or has relapsed following standard systemic therapy or haematopoietic stem cell transplantation, survival rates are poor.

“For adult patients living with ALL, there is a need for therapeutic options that provide long-term responses,” said Bijal Shah, trial investigator and medical oncologist at the Moffitt Cancer Center in Florida.

Results from the analysis of Kite’s phase 1/2 ZUMA-3 study show a median overall survival of 26 months and durable responses in adult patients with R/R B-ALL, with a consistent safety profile observed since the two-year analysis.

In the phase 2 treated patient cohort, the overall survival rate at 36 months was 47.1%, with a median overall survival of 26 months among all treated phase 2 patients and 38.9 months in patients with complete remission or complete remission with incomplete haematologic recovery.

“The continued durable response and significant improvement in survival indicated by these new data can potentially establish a new standard of care for adult patients living with this aggressive form of leukaemia,” said Shah.

Commenting further on the positive results, Frank Neumann, senior vice president, global head of clinical development at Kite, said: “We are encouraged by the sustained benefit that a single one-time treatment of Tecartus continues to provide for patients living with this difficult-to-treat blood cancer.

“Our hope is that these results, along with our commitment to long-term research of Tecartus, will continue to provide clarity to physicians on optimal treatment methods for these patients living with this rare disease who have suffered historically poor outcomes.”

The positive results come just days after the company closed a collaboration agreement with Arcellx to jointly develop and commercialise Arcellx’s late-stage CAR-T cell candidate to treat R/R multiple myeloma.

Kite also announced in December 2022 that it would acquire clinical-stage biotech Tmunity Therapeutics, bolstering the company’s established in-house cell therapy research capabilities by adding additional pipeline assets and Tmunity’s CAR-T technology platform.