Efficacy of CAR T | CAR T Hope

Clinical Trials

With extensive clinical-trial and real-world experience, CAR T therapies have the potential to help more patients1-10

Efficacy outcomes in clinical trials*

LBCL2 FL3,4,11,12 ALL5,13 MM6,14-16
ORR 69%(95% CI: 57-79) 86-95%† NA 77%(95% CI: 68-85)
CR 49%(95% CI: 44-52) 69-80%† 80% 37%(95% CI: 26-50)
12-month PFS 43%(95% CI: 35-75) 67-81%† 37%(95% CI: 28.1-47) 77-90%†
12-month OS 58%(95% CI: 49-60) 97%†‡ 58%(95% CI: 50.4-65.6) 78-89%†
ORR CR
LBCL2 69%(95% CI: 57-79) 49%(95% CI: 44-52)
FL3,4,11,12 86-95%† 69-80%†
ALL5,13 NA 80%
MM6,14-16 77%(95% CI: 68-85) 37%(95% CI: 26-50)
12-month PFS 12-month OS
LBCL2 43%(95% CI: 35-75) 58%(95% CI: 49-60)
FL3,4,11,12 67-81%† 97%†‡
ALL5,13 37%(95% CI: 28.1-47) 58%(95% CI: 50.4-65.6)
MM6,14-16 77-90%† 78-89%†

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend anti-CD19 CAR T therapy as category 1 for second-line relapsed LBCL within 12 months or primary refractory disease.17

NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.

Real-World Data

CAR T therapy is supported by real-world evidence

Efficacy outcomes in CLINICAL PRACTICE*

LBCL7-10§‖¶# ALL18** MM19-21††‡‡§§
ORR 55-82% NA 32-83%
CR 32-64% 86%(95% CI: 81-90) 34-35%
12-month PFS 32-45% NA NA
12-month OS 54-64% NA 56%
ORR CR
LBCL7-10§‖¶# 55-82% 32-64%
ALL18** NA 86%(95% CI: 81–90)
MM19-21††‡‡§§ 32-83% 34-35%
12-month PFS 12-month OS
LBCL7-10§‖¶# 32-45% 54-64%
ALL18** NA NA
MM19-21††‡‡§§ NA 56%

CAR T therapy has over 10 years of evidence and experience.22,23

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*The efficacy results shown are based on current available data. Not all indications have efficacy results available.

†Confidence intervals are not presented because data ranges derive from multiple studies.

‡Based on a 12-month OS rate of 96.8% (95% CI, 91.8-98.8) for axicabtagene ciloleucel and 96.6% (95% CI, 92.9-100) for tisagenlecleucel.11,12

§Based on a systemic review and meta-analysis of published RWE studies that included at least 2100 patients with R/R LBCL treated with CAR T therapy.7

||Based on a national, multicenter, retrospective study that evaluated the safety and efficacy of a CAR T therapy in a real-life setting in 75 patients with R/R LBCL who underwent leukapheresis with the intent to receive treatment at 10 European institutions.8

Based on a non-interventional, prospective, longitudinal study using CIBMTR registry data of 682 patients with DLBCL, HGBL, and transformed lymphoma.9

#Based on a retrospective study of 298 patients with R/R LBCL who underwent leukapheresis with the intent to receive CAR T treatment at 17 US institutions.10

**Based on a non-interventional prospective study using CIBMTR registry data of 410 pediatric/young adult patients with R/R ALL or adult patients with R/R NHL.18

††Based on a single-center study in the US of 20 patients with R/R MM who received CAR T therapy after at least 4 lines of prior therapy.19

‡‡Based on a national, multicenter, retrospective analysis of 108 patients with R/R MM after 4 prior lines of therapy from 10 US academic centers.20

§§Based on a global, non-interventional, retrospective study using real-world data of 190 patients with R/R MM.21

ALL=acute lymphoblastic leukemia; CAR T=chimeric antigen receptor T cell; CD=cluster of differentiation; CI=confidence interval; CIBMTR=Center for International Blood and Marrow Transplant Research; CR=complete remission; DLBCL=diffuse large B-cell lymphoma; FL=follicular lymphoma; HGBL=high-grade B-cell lymphoma; LBCL=large B-cell lymphoma; MM=multiple myeloma; NA=not available; NCCN=National Comprehensive Cancer Network; NHL=non-Hodgkin lymphoma; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; R/R=relapsed/refractory; RWE=real-world evidence.

References

1. Albinger N, Hartmann J, Ullrich E. Current status and perspective of CAR-T and CAR-NK cell therapy trials in Germany. Gene Ther. 2021;28(9):513-527. 2. Al-Mansour M, Al-Foheidi M, Ibrahim E. Efficacy and safety of second-generation CAR T cell therapy in diffuse large B-cell lymphoma: a meta-analysis. Mol Clin Oncol. 2020;13(4):33. 3. Fowler NH, Dickinson M, Dreyling M, et al. Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial. Nat Med. 2022;28(2):325-332. 4. Jacobson CA, Chavez JC, Sehgal AR, et al. Axicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma (ZUMA-5): a single-arm, multicentre, phase 2 trial. Lancet Oncol. 2022;23(1):91-103. 5. Anagnostou T, Riaz IB, Hashmi SK, Murad MH, Kenderian SS. Anti-CD19 chimeric antigen receptor T-cell therapy in acute lymphocytic leukemia: a systematic review and meta-analysis. Lancet Haematol. 2020;7(11)(suppl):e816-e826. 6. Yang Q, Li X, Zhang F, Yang Q, Zhou W, Liu J. Efficacy and safety of CAR-T therapy for relapse or refractory multiple myeloma: a systematic review and meta-analysis. Int J Med Sci. 2021;18(8):1786-1797. 7. Jacobson CA, Munoz J, Kanters S, et al. Effectiveness and safety of axicabtagene ciloleucel and tisagenlecleucel for large B-cell lymphoma (LBCL) in the real-world setting: a systematic review and meta-analysis. Presented at: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR; April 23-26, 2022; Salt Lake City, UT. Poster 224. 8. Iacoboni G, Villacampa G, Martinez-Cibrian N, et al; GETH, GELTAMO Spanish Groups. Real-world evidence of tisagenlecleucel for the treatment of relapsed or refractory large B-cell lymphoma. Cancer Med. 2021;10(10):3214-3223. 9. Landsburg DJ, Frigault MJ, Hu Z-H, et al. Real-world efficacy and safety outcomes for patients with relapsed or refractory (R/R) aggressive B-cell non-Hodgkin’s lymphoma (aBNHL) treated with commercial tisagenlecleucel: update from the Center for International Blood and Marrow Transplant Research (CIBMTR) registry. Presented at: 63rd ASH Annual Meeting and Exposition; December 11-14, 2021; Atlanta, GA. Presentation 429. 10. Nastoupil LJ, Jain MD, Feng L, et al. Standard-of-care axicabtagene ciloleucel for relapsed or refractory large B-cell lymphoma: results from the US Lymphoma CAR T Consortium. J Clin Oncol. 2020;38(27):3119-3128. 11. Data on file. Kite Pharma, Inc; 2021. 12. Salles G, Schuster SJ, Dreyling M, et al. Efficacy comparison of tisagenlecleucel vs usual care in patients with relapsed or refractory follicular lymphoma. Blood Adv. 2022;6(22):5835-5843. 13. Anagnostou T, Riaz IB, Hashmi SK, Murad MH, Kenderian SS. Anti-CD19 chimeric antigen receptor T-cell therapy in acute lymphocytic leukemia: a systematic review and meta-analysis. Lancet Haematol. 2020;7(11)(suppl):e816-e826. 14. Berdeja JG, Madduri D, Usmani SZ, et al. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study. Lancet. 2021;398(10297):314-324. 15. van de Donk NWCJ, Agha ME, Cohen AD, et al. Biological correlative analyses and updated clinical data of ciltacabtagene autoleucel (cilta-cel), a BCMA-directed CAR-T cell therapy, in patients with multiple myeloma (MM) and early relapse after initial therapy: CARTITUDE-2, cohort B. Presented at: 2022 ASCO Annual Meeting; June 3-7, 2022; Chicago, IL. American Society of Clinical Oncology abstract 8029. 16. Munshi NC, Anderson LD Jr, Shah N, et al. Idecabtagene vicleucel in relapsed and refractory multiple myeloma. N Engl J Med. 2021;384(8):705-716. 17. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.2.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed February 8, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. 18. Pasquini MC, Hu Z-H, Curran K, et al. Real-world evidence of tisagenlecleucel for pediatric acute lymphoblastic leukemia and non-Hodgkin lymphoma. Blood Adv. 2020;4(21):5414-5424. 19. Lovely B. Real-world data highlight efficacy of ide-cel in patients with relapsed/refractory multiple myeloma. OncLive. Published September 6, 2022. Accessed February 22, 2023. https://www.onclive.com/view/real-world-data-highlight-efficacy-of-ide-cel-in-patients-with-relapsed-refractory-multiple-myeloma 20. Hansen DK, Sidana S, Peres L, et al. Idecabtagene vicleucel (ide-cel) chimeric antigen receptor (CAR) T-cell therapy for relapsed/refractory multiple myeloma (RRMM): real-world experience. Presented at: 2022 ASCO Annual Meeting; June 3-7, 2022; Chicago, IL. Abstract 8042. 21. Jagannath S, Lin Y, Goldschmidt H, et al. KarMMa-RW: comparison of idecabtagene vicleucel with real-world outcomes in relapsed and refractory multiple myeloma. Blood Cancer J. 2021;11(6):116. 22. Grupp SA, Kalos M, Barrett D, et al. Chimeric antigen receptor-modified T cells for acute lymphoid leukemia. N Engl J Med. 2013;368(16):1509-1518. 23. Emily Whitehead, first pediatric patient to receive CAR T-cell therapy, celebrates cure 10 years later. News release. Children’s Hospital of Philadelphia. May 11, 2022. Accessed February 22, 2022. https://www.chop.edu/news/emily-whitehead-first-pediatric-patient-receive-car-t-cell-therapy-celebrates-cure-10-years