CAR-T Cell Therapy Demonstrates Survival Benefit in Patients with Relapsed/Refractory Leukemia

Tecartus (brexucabtagene autoleucel), a CAR-T cell therapy demonstrated an average overall survival (time from treatment until death of any cause) of 26 months, which remained durable in patients with relapsed/refractory b-cell acute lymphoblastic leukemia, according to a press release from Kite, the drug’s manufacturer.

The ZUMA-3 phase 2 study included 55 patients and demonstrated overall survival rate at 36 months was 47% — with a median overall survival of 26 months. And was 38.9 months in patients with complete remission or complete remission with incomplete hematologic recovery.

“For adult patients living with (acute lymphoblastic leukemia), there is a need for therapeutic options that provide long-term responses,” said Dr. Bijal Shah, the lead author on this study and medical oncologist at Moffitt Cancer Center in Tampa, Florida, in the release. “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.”

Additionally, overall complete remission rate (which is complete remission and with incomplete hematologic recovery), complete remission and subsequent allogenic stem cell transplant rates remined unchanged as 71%, 56% and 20%, respectively.

Average relapse-free survival at subsequent allogenic stem cell transplant was longer than 11 months.

For patients treated at the pivotal dose in both phase 1 and 2 of the study, median duration of response (time from response until disease progression or death) censored and not censored at subsequent allogenic stem cell transplant was 18.6 and 20.0 months, respectively. Median relapse-free survival was 11.7 months in both groups.

At the data cutoff, 36% of patients were still alive with a median overall survival of 25.6 months in all treated patients (78).

“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 Dr. Frank Neumann, Kite’s Global Head of Clinical Development, in the release. “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.”

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