Three-Year Follow-Up of KTE-X19 in Patients With Relapsed/Refractory Mantle Cell Lymphoma, Including High-Risk Subgroups, in the ZUMA-2 Study

Author:

Wang Michael1ORCID,Munoz Javier2ORCID,Goy Andre3ORCID,Locke Frederick L.4ORCID,Jacobson Caron A.5ORCID,Hill Brian T.6,Timmerman John M.7,Holmes Houston8,Jaglowski Samantha9,Flinn Ian W.10ORCID,McSweeney Peter A.11,Miklos David B.12ORCID,Pagel John M.13ORCID,Kersten Marie José14ORCID,Bouabdallah Krimo15,Khanal Rashmi16,Topp Max S.17ORCID,Houot Roch18ORCID,Beitinjaneh Amer19ORCID,Peng Weimin20,Fang Xiang20,Shen Rhine R.20,Siddiqi Rubina20ORCID,Kloos Ioana20,Reagan Patrick M.21

Affiliation:

1. The University of Texas MD Anderson Cancer Center, Houston, TX

2. Banner MD Anderson Cancer Center, Gilbert, AZ

3. John Theurer Cancer Center, Hackensack University, Hackensack, NJ

4. Moffitt Cancer Center, Tampa, FL

5. Dana-Farber Cancer Institute, Boston, MA

6. Cleveland Clinic Foundation, Cleveland, OH

7. David Geffen School of Medicine at UCLA, Los Angeles, CA

8. Texas Oncology, Dallas, TX

9. The Ohio State University Comprehensive Cancer Center, Columbus, OH

10. Sarah Cannon Research Institute and Tennessee Oncology, Nashville, TN

11. Colorado Blood Cancer Institute, Denver, CO

12. Stanford University School of Medicine, Stanford, CA

13. Swedish Cancer Institute, Seattle, WA

14. Amsterdam UMC, University of Amsterdam, Cancer Center Amsterdam, the Netherlands, on behalf of HOVON/LLPC

15. CHU Bordeaux, Service d’Hématologie et thérapie Cellulaire, Bordeaux, France

16. Fox Chase Cancer Center, Philadelphia, PA

17. Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany

18. CHU Rennes, Université Rennes, INSERM & EFS, Rennes, France

19. University of Miami, Miami, FL

20. Kite, a Gilead Company, Santa Monica, CA

21. University of Rochester Medical Center, Rochester, NY

Abstract

PURPOSE Brexucabtagene autoleucel (KTE-X19) autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy is approved for the treatment of relapsed/refractory mantle cell lymphoma (MCL). Outcomes after a 3-year follow-up in the pivotal ZUMA-2 study of KTE-X19 in relapsed/refractory MCL are reported, including for subgroups by prior therapy (bendamustine and type of Bruton tyrosine kinase inhibitor [BTKi]) or high-risk characteristics. METHODS Patients with relapsed/refractory MCL (one to five prior therapies, including prior BTKi exposure) received a single infusion of KTE-X19 (2 × 106 CAR T cells/kg). RESULTS After a median follow-up of 35.6 months, the objective response rate among all 68 treated patients was 91% (95% CI, 81.8 to 96.7) with 68% complete responses (95% CI, 55.2 to 78.5); medians for duration of response, progression-free survival, and overall survival were 28.2 months (95% CI, 13.5 to 47.1), 25.8 months (95% CI, 9.6 to 47.6), and 46.6 months (95% CI, 24.9 to not estimable), respectively. Post hoc analyses showed that objective response rates and ongoing response rates were consistent among prespecified subgroups by prior BTKi exposure or high-risk characteristics. In an exploratory analysis, patients with prior bendamustine benefited from KTE-X19, but showed a trend toward attenuated T-cell functionality, with more impact of bendamustine given within 6 versus 12 months of leukapheresis. Late-onset toxicities were infrequent; only 3% of treatment-emergent adverse events of interest in ZUMA-2 occurred during this longer follow-up period. Translational assessments revealed associations with long-term benefits of KTE-X19 including high-peak CAR T-cell expansion in responders and the predictive value of minimal residual disease for relapse. CONCLUSION These data, representing the longest follow-up of CAR T-cell therapy in patients with MCL to date, suggest that KTE-X19 induced durable long-term responses with manageable safety in patients with relapsed/refractory MCL and may also benefit those with high-risk characteristics.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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