EFFICACY | SAFETY | ZUMA-2 | OTHER | STUDY DESIGN |
---|---|---|---|---|
ORR & CR Rate demonstrated in ZUMA-2
93% & 67%
|
Grade ≥3 CRS
13%
|
What bridging therapy allowed in ZUMA-2
BTK (ibrutinib or acalabrutinib and steroids)
|
Number of Days for Peak Level of Anti-CD19 CAR- T cells
7-14 days
|
Primary Endpoints
Objective Response Rate (ORR)
|
Median PFS
25.8 months
|
Grade ≥3 ICANS
33%
|
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
|
Patients in the primary analysis and total treated in the study
60 & 68 patients
|
Secondary Endpoints
Duration of Response (DOR), Overall Survival (OS), Progression Free Survival (PFS) and severity of AEs
|
Median OS
46.6 months
|
Recommendations for Severe CRS and Severe Neurotoxicity
Echocardiogram to assess cardiac function, consider intensive care support
|
Median number of prior lines of therapy
3 lines of therapy
|
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
|
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)
|