RARE Daily

Kite Reports CAR-T Therapy Demonstrates Survival Benefit in Three-Year Follow-up in B-ALL

February 13, 2023

Rare Daily Staff

Gilead’s Kite Pharma reported that three-year follow-up results from the pivotal ZUMA-3 study of the CAR T-cell therapy Tecartus showed a median overall survival of 26 months and demonstrated that responses remained durable in adults with relapsed/refractory B-cell acute lymphoblastic leukemia.

The findings were presented during a poster session at the 5th European CAR T-cell Meeting, in Rotterdam, the Netherlands.

“For adult patients living with ALL, there is a need for therapeutic options that provide long-term responses,” said Bijal Shah, ZUMA-3 investigator and medical oncologist at the Moffitt Cancer Center in Tampa, Florida. “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 leukemia.”

ALL is an aggressive and rare type of blood cancer that can also involve the lymph nodes, spleen, liver, central nervous system, and other organs. While 80 percent of ALL occurs in children, it represents a devastating disease in adults. In adults, B-cell precursor ALL is the most common form, accounting for 75 percent of cases. Survival rates in adults with R/R B-ALL are poor, with median OS at less than eight months.

Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

In the phase 2 treated patient cohort the median follow-up was 38.8 months. The overall survival rate at 36 months was 47.1 percent, with a median OS of 26 months among all treated phase 2 patients and 38.9 months in patients with complete remission or complete remission with incomplete hematologic recovery.

“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,” said Frank Neumann, Kite’s global head of Clinical Development. “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.”

ZUMA-3 is an ongoing international multicenter, single arm, open label, registrational phase 1/2 study of Tecartus in adult patients with ALL whose disease is refractory to or has relapsed following standard systemic therapy or hematopoietic stem cell transplantation. The primary endpoint is the rate of overall complete remission or complete remission with incomplete hematological recovery by central assessment. Duration of remission and relapse-free survival, overall survival, minimal residual disease negativity rate, and alloSCT rate were assessed as secondary endpoints.

Photo: Frank Neumann, Kite’s global head of Clinical Development


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