1) Several CAR-T cell therapies have been approved by the FDA for the treatment of various hematologic malignancies including B-cell ALL, DLBCL, FL, MCL, and MM in adults. These include tisagenlecleucel, axicabtagene ciloleucel, brexucabtagene autoleucel, idecabtagene vicleucel, and ciltacabtagene autoleucel. 2) Ongoing clinical trials are directly comparing CAR-T cell therapy to autologous stem cell transplantation for the treatment of hematologic malignancies. 3) Additional clinical trials are investigating the use of CAR-T cell therapies

1. Current Regulatory Status and Next Steps With
CAR-T Cell Therapy in Hematologic Malignancies
Full abbreviations, accreditation, and disclosure information available at
PeerView.com/HEH40
ALL
Anti-CD19 CAR-T Cell Therapy
Anti-CD19 CAR-T Cell Therapy
Patients aged ≤25 y
with B-cell precursor ALL
(refractory or in second
or later relapse)
FDA approved
Tisagenlecleucel
(CTL019)1
Adult R/R
B-cell precursor ALL
FDA approved
Brexucabtagene
autoleucel
(KTE-X19)2
Adult R/R
B-cell precursor ALL
after ≥2 lines
of systemic therapy
Phase 1/2
Axicabtagene ciloleucel
(KTE-C19)3,4
Pediatric and young
adult R/R B-cell ALL
Lisocabtagene maraleucel
(JCAR017)5
Phase 1/2 (NCT03743246)
FL
Adult patients with R/R FL after ≥2
lines of systemic therapy
FDA approved
Axicabtagene ciloleucel
(KTE-C19)6
Adult patients with R/R FL after ≥2
lines of systemic therapy
FDA approved
Tisagenlecleucel
(CTL019)15
RRMM
Adult patients with RRMM after ≥4
prior lines of therapy
FDA approved
Idecabtagene vicleucel
(bb2121)16-18
Adult patients with RRMM after ≥4
prior lines of therapy
FDA approved
Ciltacabtagene autoleucel
(LCAR-B38M)19
MCL
Adult patients
with R/R MCL
FDA approved
Brexucabtagene autoleucel
(KTE-X19)2,12
Adult patients
with R/R MCL
Phase 1 (TRANSCEND-NHL)
Lisocabtagene maraleucel
(JCAR017)13
BELINDA:
tisagenlecleucel
vs SOC
ZUMA-7:
axicabtagene ciloleucel
vs SOC
TRANSFORM:
lisocabtagene maraleucel
vs SOC
DLBCL
Adult patients with R/R
large B-cell lymphoma
after ≥2 lines
of systemic therapy
FDA approved
Tisagenlecleucel
(CTL019)1
FDA approved
Axicabtagene ciloleucel
(KTE-C19)6
Adult patients with R/R large
B-cell lymphoma
after ≥2 lines
of systemic therapy
Lisocabtagene maraleucel
(JCAR017)7,8
FDA approved
Next
Steps
Directly comparing
CAR-T cell therapy
with ASCT9-11
Next
Steps
Lisocabtagene
maraleucel in CLL
(TRANSCEND-CLL):
active in heavily pretreated
patients with R/R CLL/SLL
(including those who
received prior ibrutinib
and/or venetoclax)14
Adult patients with R/R
large B-cell lymphoma
after ≥2 lines of systemic therapy
or within 12 months of 1L
chemoimmunotherapy
1. Kymriah (tisagenlecleucel) Prescribing Information. https://www.novartis.us/sites/www.novartis.us/files/kymriah.pdf. 2. Tecartus (brexucabtagene autoleucel) Prescribing Information. https://www.fda.gov/media/
140409/download. 3. Wierda WG et al. 60th American Society of Hematology Annual Meeting & Exposition (ASH 2018). Abstract 897. 4. Lee DW et al. 42nd European Society for Medical Oncology Congress (ESMO 2017).
Abstract 1008PD. 5. https://www.clinicaltrials.gov/ct2/show/NCT03743246. 6. Yescarta (axicabtagene ciloleucel) Prescribing Information. https://www.fda.gov/media/108377/download. 7. Abramson JS et al. Lancet. 2020;
396:839-852. 8. Breyanzi (lisocabtagene maraleucel) Prescribing Information. https://www.fda.gov/media/145711/download. 9. Bishop MR et al. N Engl J Med. 2022;386:629-639. 10. Locke FL et al. N Engl J Med. 2022;386:
640-654. 11. Kamdar M et al. ASH 2021. Abstract 91. 12. Wang M et al. N Engl J Med. 2020;382:1331-1342. 13. Palomba ML et al. Blood. 2020;136:10. 14. Siddiqi T et al. Blood. 2022;139:1794-1806. 15. Fowler NH et al. Nat Med.
2022;28:325-332. 16. Abecma (idecabtagene vicleucel) Prescribing Information. https://www.fda.gov/media/147055/download. 17. Raje N et al. N Engl J Med. 2019;380:1726-1737. 18. Munshi NC et al. N Engl J Med. 2021;
384:705-716. 19. Berdeja JG et al. Lancet. 2021;398:314-324.