Kite, a Gilead Company, presented promising data on Tecartus (brexucabtagene autoleucel) for relapsed/refractory mantle cell lymphoma (R/R MCL) and B-cell precursor acute lymphoblastic leukemia (R/R B-ALL) at the American Society of Hematology meeting. The ZUMA-2 trial showed high overall and complete response rates in BTKi-naïve R/R MCL patients, while five-year follow-up data revealed prolonged overall survival, making Tecartus the only CAR T therapy with such long-term data in this population. Real-world evidence analyses further confirmed Tecartus’s effectiveness and safety in a broader R/R B-ALL patient group.
These findings are particularly noteworthy given the aggressive nature and poor prognoses associated with relapsed/refractory MCL and B-ALL. The five-year survival data for Tecartus in R/R MCL represents a significant advancement, offering new hope for patients who have exhausted other treatment options. The consistent efficacy observed across different patient subgroups, including those who are BTKi-naïve, further strengthens Tecartus’s position as a potential treatment option earlier in the disease course. For R/R B-ALL, the real-world data reinforces the clinical trial results and suggests that Tecartus may provide benefit to a wider range of patients than initially studied.
ZUMA-2 Cohort 3, focusing on BTKi-naïve R/R MCL patients, achieved a 91% overall response rate and a 73% complete response rate. The five-year follow-up analysis of ZUMA-2 Cohorts 1 and 2 showed a 39% overall survival rate, a crucial benchmark in this challenging patient population. Real-world data from the CIBMTR registry mirrored the ZUMA-3 trial results, showing high complete response rates and promising survival outcomes in R/R B-ALL. A separate analysis from ZUMA-3 indicated that Tecartus’s effectiveness is not limited by disease burden and that early CAR T cell expansion correlates with better and more durable responses. Furthermore, the data suggests Tecartus can be successfully manufactured and produce robust responses regardless of white blood cell or lymphocyte counts, expanding its potential applicability to a broader patient base.
These positive results suggest that Tecartus has the potential to reshape the treatment landscape for both R/R MCL and R/R B-ALL. The long-term survival data, coupled with consistent efficacy across different patient subgroups and real-world settings, positions Tecartus as a valuable therapeutic option. Further research and clinical experience will help refine patient selection strategies and optimize treatment protocols, potentially leading to even better outcomes for individuals battling these aggressive blood cancers.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.