Interim results from Novartis-sponsored JULIET study shows positive outcome in adult patients with relapsed and refractory (r/r) Diffuse Large B-cell lymphoma (DLBCL).
The study uses tisagenlecleucel-T, an investigational CD19-targeting CAR-T therapy to target adult patients who are refractory to primary and second-line therapies or whose cancer has relapsed after stem cell transplantation. Previously tisagenlecleucel-T (marketed as Kymriah) gained FDA approval for the treatment of relapsed and refractory (r/r) B-cell acute lymphoblastic leukemia.
The study evaluated the overall response rate (percentage of patients with complete or partial response) in 93 patients after tisagenlecleucel-T infusion. The median time from infusion to data cutoff was 14 months. Data published in the New England Journal of Medicine showed that 40% of patients infused with CAR-T cells achieved complete remission and 12% had partial responses. At 12 months after the initial response, the rate of relapse-free survival was estimated to be 65% (79% among patients with a complete response).
22% of patients in the trial experienced grade 3 or 4 cytokine release syndrome (CRS), a complication known to occur when the engineered cells become activated in the patient’s body. However there were no deaths due to CRS. Other adverse events include neurological events, cytopenias, infections and febrile neutropenia. Three patients died 30 days after infusion, but these were not related to tisagenlecleucel-T.
Data thus far shows high response rate in adult DLBCL patients after tisagenlecleucel infusion. The trial is expected to complete in 2023.
Source: Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma. DOI