Topline Presentation Points 

HDT autoHSCT prior to CAR-T
ASH Session

ASH Abstract 2. Primary Analysis of ZUMA-7: A Phase 3 Randomized Trial of Axicabtagene Ciloleucel (Axi-Cel) Versus Standard-of-Care Therapy in Patients with Relapsed/Refractory Large B-Cell Lymphoma
Frederick L. Locke et al.

Table. Outcomes (axi-cel vs. SOC)

ASH Abstracts
Lisocabtagene Maraleucel (liso-cel)

ASH Abstract 91. CD19-Directed Chimeric Antigen Receptor (CAR) T Cell Therapy, Versus Standard of Care (SOC) with Salvage Chemotherapy (CT) Followed By Autologous Stem Cell Transplantation (ASCT) As Second-Line (2L) Treatment in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL): Results from the Randomized Phase 3 Transform Study
Manali Kamdar et al.

Table. Outcomes (liso-cel vs. SOC)

Tisagenlecluecel

ASH LBA 6. Tisagenlecleucel Vs Standard of Care As Second-Line Therapy of Primary Refractory or Relapsed Aggressive B-Cell Non-Hodgkin Lymphoma: Analysis of the Phase III Belinda Study

Table. Outcomes (tisa-cel vs. SOC)

Additional Presenter Perspective:

  • What happened with the BELINDA trial [results]?
    • Likely impacted by the trial design re: bridging therapy given routinely which may reflect how it will be used in real-world practice

Fitness and CAR-T
  • ECOG status is extremely important
    • Poor ECOG from lymphoma is the same as poor ECOG from other causes
  •  CAR-T has unique toxicities
    • Cytokine release syndrome (CRS) – fevers, hypotension, hypoxia
    • Immune effector associated neurotoxicity syndrome (ICANS) – tremor, agraphia, delirium; rarely seizures, increased ICP (intra cranial pressure)
  • Should we be incorporating a 6MWT into the CAR-T evaluation?
    • Probably a better test of fitness than some of the routine testing we do (i.e. PFTs)
      • Would be good to have a composite index (i.e. with ECOG, 6MWT, LDH level) to help guide exclusions
      • Especially as we are dealing with increasing costs to health care in Canada
  • Also important to elicit patient involvement in these decisions

Additional Presenter Perspective:

  • Data presented at ASH Suggests CAR-T works well in the second-line setting for patients with primary refractory disease for whom standard ritux-chemo based therapy is ineffective. This WILL BE PRACTICE CHANGING
    • Only 36-47% pts will get to a transplant (vs. >90% with CAR-T)
    • In the patients who did get to transplant are there biomarkers of response
    • May replace high dose chemo and transplant in this population
  • Full data review and cost analysis needed
    • ~40K for transplant vs >500K for CAR-T … but a lot of these pts would proceed to CAR-T because of lack of response to salvage therapy anyway
    • Differences between the products is a possibility, but hard to prove

ASH Abstract 530. Real-World Outcomes of Axicabtagene Ciloleucel (Axi-cel) for the Treatment of Large B-Cell Lymphoma (LBCL): Impact of Age and Specific Organ Dysfunction
Frederick L. Locke et al.

Multivariate analysis

  • ECOG is strongly associated with ORR, OS and PFS
  • cardiac, renal and hepatic dysfunction are associated with OS

ASH Abstract 570. Physical Therapy Assessment of Baseline Function and Endurance Predicts Short Term Outcomes in Commercial CAR T Patient with Lymphoma
Geoffrey Shouse et al.


Driving beyond B cell malignances – [New Indications going forward]

ASH Abstract 550. Ciltacabtagene Autoleucel for Triple-Class Exposed Multiple Myeloma: Adjusted Comparisons of CARTITUDE-1 Patient Outcomes Versus Therapies from Real-World Clinical Practice from the LocoMMotion Prospective Study
Maria-Victoria Mateos et al.

CARTITUDE-1 is a phase 1b/2 trial (single arm) of cilta-cel in triple exposed myeloma pts

  • Excellent results seen with 80.4% sCR (abstract 549)
  • 18-month PFS 66% and OS 80.9%

LocoMMotion

  • designed a priori to serve as an external control cohort for CARTITUDE-1, using aligned inclusion criteria and endpoint definitions to enable indirect comparisons

Additional Presenter Perspective: Data Strongly suggests cilta-cel is superior to best available therapy