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Association details:
Evidence:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

EFFICACY AND SAFETY OF TISAGENLECLEUCEL IN PEDIATRIC AND YOUNG ADULT PATIENTS (PTS) WITH RELAPSED OR REFRACTORY (R/R) MATURE B-CELL NON-HODGKIN LYMPHOMA (NHL): THE PHASE II BIANCA STUDY

Published date:
05/12/2022
Excerpt:
Median time from enrollment to infusion was 35 d (range, 7-62 d). Median time from tisagenlecleucel infusion to data cutoff was 16 mo (range, 6-30 mo). Bridging chemotherapy was given to 94%. ORR was 32% (95% CI: 15.9-52.4); 7% had a CR. Subgroup analysis suggested that pts with BL had a lower ORR than pts with LBCL (20% vs 46%). Median PFS was 2.5 mo (95% CI: 1.1-2.9); median OS was 11.4 mo (95% CI: 3.4-not estimable); 12-mo estimated PFS and OS were 23% (95% CI: 8.9-40.3) and 47% (95% CI: 26.6-65.0), respectively. Of the 18 BL pts, 7 (39%) are alive post infusion (1 received allogeneic SCT, 1 surgery, 3 other tx, and 2 no other tx). Tisagenlecleucel demonstrated efficacy in pediatric and young adult pts with r/r mature B-NHL and comparable safety to that recorded in adults with DLBCL
Trial ID: