Catherine S. Diefenbach, MD, Discusses Gaps Filled by Approval of Liso-Cel in Second-Line Relapsed/Refractory LBCL

Approval Alert | <b>Liso-Cel for Relapsed/Refractory LBCL in Second Line</b>

Catherine S. Diefenbach, MD, spoke about the approval of lisocabtagene maraleucel for patients with relapsed/refractory large B-cell lymphoma who do not have chemotherapy-sensitive disease.

CancerNetwork® spoke with Catherine S. Diefenbach, MD, director of both Hematology and Translational Research and the Clinical Lymphoma Program of Perlmutter Cancer Center at NYU Langone Health, about the recent approval of lisocabtagene maraleucel (liso-cel; Breyanzi) for the second-line treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL).1 The approval includes patients who have diffuse large B-cell lymphoma not otherwise specified, including DLBCL arising from indolent lymphoma; high-grade B-cell lymphoma; primary mediastinal LBCL; and grade 3B follicular lymphoma may receive this treatment as well. Results from the phase 3 TRANSFORM trial (NCT03575351) supported the approval, with a median event-free survival of 10.1 months (95% CI, 6.1-not reached) with liso-cel vs 2.3 months (95% CI, 2.2-4.3) with standard of care in the indicated patient population.2


Patients who do not have chemotherapy-sensitive disease historically have extremely poor outcomes to second- and third-line chemotherapy, which is just more of the same. If you don’t respond to first-line chemotherapy, your chances of responding to each subsequent line of chemotherapy get smaller and smaller, and your chances of cure with an autologous stem cell transplant—which is a way to deliver higher doses of chemotherapy, there’s nothing immunologic about autologous transplant—wasn’t likely to cure you if you didn’t have sensitive disease to begin with. These patients who have primary refractory DLBCL are generally dying within a year of their relapse. This is a huge unmet need for which CAR T cells are, not curing all these patients, curing some of these patients. That is addressing a tremendous unmet medical need.


  1. U.S. FDA approves Bristol Myers Squibb’s CAR T cell therapy Breyanzi for relapsed or refractory large B-cell lymphoma after one prior therapy. News release. Bristol Myers Squibb. June 24, 2022. Accessed June 28, 2022.
  2. Kamdar M, Solomon SR, Arnason J, et al. Lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, versus standard of care (SOC) with salvage chemotherapy (CT) followed by autologous stem cell transplantation (ASCT) as second-line (2L) treatment in patients (Pts) with relapsed or refractory (R/R) large B lymphoma (LBCL): results from the randomized phase 3 transform study. Blood. 2021;138(1):91. doi:10.1182/blood-2021-147913