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Second-line tisa-cel similar to standard-of-care for R/R aggressive non-Hodgkin lymphoma

Presented by
Dr Michael Bishop, University of Chicago, IL, USA
ASH 2021
Phase 3, BELINDA
The chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (tisa-cel) as second-line treatment did not improve event-free survival (EFS) of patients with relapsed or refractory (R/R) aggressive B-cell non-Hodgkin lymphoma compared with standard-of-care [1]. These results of the phase 3 BELINDA study contradicts previous CAR T-cell therapy trials that have shown improved clinical outcomes.

Tisa-cel, an autologous CAR T-cell therapy targeting CD19, is approved for patients with diffuse large B-cell lymphoma (DLBCL) after ‚Č•2 lines of therapy [2,3]. Dr Michael Bishop (University of Chicago, IL, USA) presented the results of the BELINDA trial (NCT03570892), which enrolled 322 adults with confirmed R/R aggressive non-Hodgkin lymphoma within 12 months after first-line chemo-immunotherapy. All patients underwent leukapheresis for tisa-cel production and were randomised 1:1 to receive tisa-cel (arm A) or standard-of-care (arm B). Patients in arm A could receive bridging therapy, defined as an investigator choice of protocol-defined platinum-based chemotherapy, followed by lymphodepletion and a single tisa-cel infusion. Responders in arm B received investigator choice of platinum-based chemotherapy regimen followed by autologous haematopoietic cell transplantation in responders, and non-responders received a second platinum-based chemotherapy. The primary endpoint was EFS, defined as death at any time or progressive or stable disease at or after 12 weeks.

The median EFS was 3 months in both arms (HR 1.07; 95% CI 0.82‚Äď1.40; P=0.69). At week 12, the overall response rate (ORR) was 46% in arm A versus 43% in arm B. The complete response rate was 28% in both arms. A higher proportion of patients had progressive disease at week 6, prior to CAR T-cell infusion, in the tisa-cel arm.

‚ÄúOur findings suggest the importance of preventing progressive disease prior to CAR T-cell infusion,‚ÄĚ Dr Bishop concluded. Moreover, effective bridging prior to CAR T-cell infusion and a shorter time to infusion for this chemotherapy-refractory patient population could be critical to improving outcomes.

  1. Bishop MR. 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. LBA-6, ASH 2021 Annual Meeting, 11‚Äď14 December.
  2. Maude SL, et al. N Engl J Med 2018;378:439‚Äď448.
  3. Schuster SJ, et al. N Engl J Med 2019;380:45‚Äď56.

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