EFFICACY SAFETY ZUMA-2 OTHER STUDY DESIGN
30
ORR & CR Rate demonstrated in ZUMA-2
93% & 67%
20
Grade ≥3 CRS
13%
10
What bridging therapy allowed in ZUMA-2
BTK (ibrutinib or acalabrutinib and steroids)
20
Number of Days for Peak Level of Anti-CD19 CAR- T cells
7-14 days
10
Primary Endpoints
Objective Response Rate (ORR)
20
Median PFS
25.8 months
30
Grade ≥3 ICANS
33%
30
Exclusion Criteria
Active or Serious infection, Prior Allogeneic stem cell transplant, Detectable cerebrospinal fluid malignant cells or brain mets, History of CNS lymphoma or CNS disorders
10
Patients in the primary analysis and total treated in the study
60 & 68 patients
20
Secondary Endpoints
Duration of Response (DOR), Overall Survival (OS), Progression Free Survival (PFS) and severity of AEs
10
Median OS
46.6 months
10
Recommendations for Severe CRS and Severe Neurotoxicity
Echocardiogram to assess cardiac function, consider intensive care support
20
Median number of prior lines of therapy
3 lines of therapy
30
What is the dosage of Tecartus for MCL
2 x 10⁶ Anti-CD19 CAR T cells/kg of bodyweight with a max of 2 x 10⁸ Anti-CD19 CAR T cells /kg of bodyweight
30
Inclusion criteria
MCL, ≥18 years, Disease progression after last regimen or refractory disease to most recent therapy, Prior anthracycline or bendamustine-containing chemotherapy, anti-cd20 monoclonal antibody therapy and a BTKi (ibrutnib or acalabrutinib)






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