Kite's Tecartus® CAR T-Cell Therapy Shows Long-Term Efficacy and Survival Benefits at ASH 2024

SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite, a Gilead Company, has recently shared new findings that emphasize the enduring efficacy of Tecartus (brexucabtagene autoleucel) for patients suffering from relapsed or refractory mantle cell lymphoma (R/R MCL) and B-cell precursor acute lymphoblastic leukemia (R/R B-ALL). The announcement was made during the 66th American Society of Hematology (ASH) Annual Meeting and Exposition. The data presented highlighted the sustained response of Tecartus, offering encouraging prospects for affected individuals.

A significant portion of the presentation centered on the ZUMA-2 cohort 3 study, which revealed a 91% overall response rate (ORR) and a 73% complete response (CR) rate in patients with R/R MCL who had not been previously treated with Bruton tyrosine kinase inhibitors (BTKi). The study underscored the long-term benefits of Tecartus, with 39% of patients in earlier ZUMA-2 cohorts surviving past five years. This positions Tecartus as the only CAR T-cell therapy with such extensive follow-up data for this particular illness.

In addition, real-world evidence presented for adults with R/R B-ALL treated with Tecartus demonstrated substantial effectiveness and a consistent safety profile. This data extended beyond what was observed in the pivotal ZUMA-3 study, showcasing the broad applicability of the treatment in diverse patient populations.

Kite's Global Head of Medical Affairs, Dominique Tonelli, highlighted the persistent efficacy and survival benefits of Tecartus, emphasizing its potential impact across various patient subgroups. The treatment's success in generating robust responses is attributed to Kite's advanced manufacturing capabilities, which ensure effective outcomes regardless of individual variations in white blood cell or lymphocyte count.

The ASH meeting also featured detailed analyses of the Tecartus trials. In the ZUMA-2 cohort 3 study, involving 86 patients who had not received BTKi treatment, the median follow-up period was 15.5 months. The study achieved its primary endpoint with a 91% ORR. The 12-month rates for duration of response, progression-free survival, and overall survival were notably high, at 80%, 75%, and 90%, respectively.

Dr. Tom van Meerten, a lead investigator in the study, expressed optimism regarding the high response rates and durability of Tecartus, particularly in patients with high-risk R/R MCL who are BTKi-naïve. The safety profile of Tecartus was consistent, with manageable levels of cytokine release syndrome and neurological events.

For the five-year follow-up in ZUMA-2 cohorts 1 and 2, data revealed no new safety concerns and a significant portion of patients continued to show positive outcomes. The study demonstrated a sustained median duration of response and overall survival, reinforcing Tecartus's long-term benefits.

In a real-world analysis of R/R B-ALL patients, Tecartus exhibited a high overall effectiveness in a large group of 242 adults. With a median follow-up of 7.2 months, the complete response rate post-treatment was 80%, and the six-month relapse-free survival and overall survival rates were 55% and 80%, respectively. These findings were consistent with earlier controlled studies, establishing Tecartus as a valuable treatment option for difficult-to-treat blood cancers.

Dr. Kitsada Wudhikarn, the lead investigator of the real-world analysis, highlighted the consistency of Tecartus's efficacy and safety across different treatment histories and patient risk profiles. This evidence further supports the use of Tecartus as a potent therapy for challenging blood malignancies.

Overall, Kite's presentation at the ASH meeting showcased the significant impact of Tecartus in treating R/R MCL and R/R B-ALL, offering hope for patients facing these aggressive forms of cancer.