Literature DB >> 35850429

Patterns of Use, Outcomes, and Resource Utilization among Recipients of Commercial Axicabtagene Ciloleucel and Tisagenlecleucel for Relapsed/Refractory Aggressive B Cell Lymphomas.

Peter A Riedell1, Wei-Ting Hwang2, Loretta J Nastoupil3, Martina Pennisi4, Joseph P McGuirk5, Richard T Maziarz6, Veronika Bachanova7, Olalekan O Oluwole8, Jamie Brower9, Oscar A Flores3, Nausheen Ahmed5, Levanto Schachter6, Kharmen Bharucha7, Bhagirathbhai R Dholaria8, Stephen J Schuster9, Miguel-Angel Perales10, Michael R Bishop1, David L Porter11.   

Abstract

Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) are CD19-directed chimeric antigen receptor (CAR) T cell therapies approved for the treatment of relapsed/refractory aggressive B cell lymphomas. We present a multicenter retrospective study among centers that prescribe either commercial product to evaluate usage patterns, safety and efficacy outcomes, and resource utilization. Data collection included all patients from 8 US centers who underwent apheresis between May 1, 2018, and July 31, 2019. Patient selection, toxicity management, and disease assessment followed institutional practices. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy consensus criteria, and tumor responses were assessed according to the Lugano 2014 classification scheme. A total of 260 patients underwent apheresis, including 168 (65%) for axi-cel and 92 (35%) for tisa-cel. Among the infused patients, the median age was 59 years for axi-cel recipients and 67 years for tisa-cel recipients (P < .001). The median time from apheresis to infusion was 28 days for axi-cel recipients and 45 days for tisa-cel recipients (P < .001). Sixty-one percent of the axi-cel recipients and 43% of the tisa-cel recipients would have been ineligible for the ZUMA-1 and JULIET trials, respectively. Grade ≥3 CRS occurred in 9% of axi-cel recipients and in 1% of tisa-cel recipients (P = .017), and grade ≥3 ICANS was seen in 38% of axi-cel recipients and 1% of tisa-cel recipients (P < .001). Inpatient cell therapy infusion was common (92% in axi-cel recipients, 37% in tisa-cel recipients). The day 90 overall response rate was 52% in the axi-cel group and 41% in the tisa-cel group (P = .113), with complete response in 44% and 35%, respectively (P = .319). Twelve-month progression-free survival (42% versus 32%; P = .206) and overall survival (62% versus 59%; P = .909) rates were comparable in the axi-cel and tisa-cel groups. Baseline characteristics differed between the 2 groups, although response rates and survival outcomes were comparable, albeit lower than those in the pivotal trials. Safety and resource utilization appear to be key differentiators between axi-cel and tisa-cel.
Copyright © 2022 The American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Aggressive large B cell lymphoma; CAR T cell therapy outcomes; CAR T cell toxicity; Chimeric antigen receptor T cell therapy; Resource utilization

Mesh:

Substances:

Year:  2022        PMID: 35850429      PMCID: PMC9547952          DOI: 10.1016/j.jtct.2022.07.011

Source DB:  PubMed          Journal:  Transplant Cell Ther        ISSN: 2666-6367


  21 in total

1.  Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study.

Authors:  Michael Crump; Sattva S Neelapu; Umar Farooq; Eric Van Den Neste; John Kuruvilla; Jason Westin; Brian K Link; Annette Hay; James R Cerhan; Liting Zhu; Sami Boussetta; Lei Feng; Matthew J Maurer; Lynn Navale; Jeff Wiezorek; William Y Go; Christian Gisselbrecht
Journal:  Blood       Date:  2017-08-03       Impact factor: 22.113

2.  Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma.

Authors:  Stephen J Schuster; Michael R Bishop; Constantine S Tam; Edmund K Waller; Peter Borchmann; Joseph P McGuirk; Ulrich Jäger; Samantha Jaglowski; Charalambos Andreadis; Jason R Westin; Isabelle Fleury; Veronika Bachanova; S Ronan Foley; P Joy Ho; Stephan Mielke; John M Magenau; Harald Holte; Serafino Pantano; Lida B Pacaud; Rakesh Awasthi; Jufen Chu; Özlem Anak; Gilles Salles; Richard T Maziarz
Journal:  N Engl J Med       Date:  2018-12-01       Impact factor: 91.245

3.  Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial.

Authors:  Frederick L Locke; Armin Ghobadi; Caron A Jacobson; David B Miklos; Lazaros J Lekakis; Olalekan O Oluwole; Yi Lin; Ira Braunschweig; Brian T Hill; John M Timmerman; Abhinav Deol; Patrick M Reagan; Patrick Stiff; Ian W Flinn; Umar Farooq; Andre Goy; Peter A McSweeney; Javier Munoz; Tanya Siddiqi; Julio C Chavez; Alex F Herrera; Nancy L Bartlett; Jeffrey S Wiezorek; Lynn Navale; Allen Xue; Yizhou Jiang; Adrian Bot; John M Rossi; Jenny J Kim; William Y Go; Sattva S Neelapu
Journal:  Lancet Oncol       Date:  2018-12-02       Impact factor: 41.316

Review 4.  Diffuse Large B-Cell Lymphoma.

Authors:  Laurie H Sehn; Gilles Salles
Journal:  N Engl J Med       Date:  2021-03-04       Impact factor: 91.245

5.  Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification.

Authors:  Bruce D Cheson; Richard I Fisher; Sally F Barrington; Franco Cavalli; Lawrence H Schwartz; Emanuele Zucca; T Andrew Lister
Journal:  J Clin Oncol       Date:  2014-09-20       Impact factor: 44.544

6.  GLA/DRST real-world outcome analysis of CAR T-cell therapies for large B-cell lymphoma in Germany.

Authors:  Wolfgang A Bethge; Peter Martus; Michael Schmitt; Udo Holtick; Marion Subklewe; Bastian von Tresckow; Francis Ayuk; Eva Marie Wagner-Drouet; Gerald G Wulf; Reinhard Marks; Olaf Penack; Ulf Schnetzke; Christian Koenecke; Malte von Bonin; Matthias Stelljes; Bertram Glass; Claudia D Baldus; Vladan Vucinic; Dimitrios Mougiakakos; Max Topp; Matthias A Fante; Roland Schroers; Lale Bayir; Peter Borchmann; Veit Buecklein; Justin Hasenkamp; Christine Hanoun; Simone Thomas; Dietrich W Beelen; Claudia Lengerke; Nicolaus Kroeger; Peter Dreger
Journal:  Blood       Date:  2022-07-28       Impact factor: 25.476

Review 7.  ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells.

Authors:  Daniel W Lee; Bianca D Santomasso; Frederick L Locke; Armin Ghobadi; Cameron J Turtle; Jennifer N Brudno; Marcela V Maus; Jae H Park; Elena Mead; Steven Pavletic; William Y Go; Lamis Eldjerou; Rebecca A Gardner; Noelle Frey; Kevin J Curran; Karl Peggs; Marcelo Pasquini; John F DiPersio; Marcel R M van den Brink; Krishna V Komanduri; Stephan A Grupp; Sattva S Neelapu
Journal:  Biol Blood Marrow Transplant       Date:  2018-12-25       Impact factor: 5.742

8.  CAR T cell viability release testing and clinical outcomes: is there a lower limit?

Authors:  Elise A Chong; Bruce L Levine; Stephan A Grupp; Megan M Davis; Don L Siegel; Shannon L Maude; Whitney L Gladney; Noelle V Frey; David L Porter; Wei-Ting Hwang; Emeline R Chong; Carl H June; Stephen J Schuster
Journal:  Blood       Date:  2019-11-21       Impact factor: 22.113

9.  Axicabtagene Ciloleucel in the Non-Trial Setting: Outcomes and Correlates of Response, Resistance, and Toxicity.

Authors:  Caron A Jacobson; Bradley D Hunter; Robert Redd; Scott J Rodig; Pei-Hsuan Chen; Kyle Wright; Mikel Lipschitz; Jerome Ritz; Yusuke Kamihara; Philippe Armand; Sarah Nikiforow; Michael Rogalski; Joseph Maakaron; Samantha Jaglowski; Marcela V Maus; Yi-Bin Chen; Jeremy S Abramson; Justin Kline; Elizabeth Budde; Alex Herrera; Matthew Mei; Jonathon B Cohen; Stephen D Smith; David G Maloney; Ajay K Gopal; Matthew J Frigault; Utkarsh H Acharya
Journal:  J Clin Oncol       Date:  2020-07-15       Impact factor: 50.717

10.  Infection during the first year in patients treated with CD19 CAR T cells for diffuse large B cell lymphoma.

Authors:  Kitsada Wudhikarn; M Lia Palomba; Martina Pennisi; Marta Garcia-Recio; Jessica R Flynn; Sean M Devlin; Aishat Afuye; Mari Lynne Silverberg; Molly A Maloy; Gunjan L Shah; Michael Scordo; Parastoo B Dahi; Craig S Sauter; Connie L Batlevi; Bianca D Santomasso; Elena Mead; Susan K Seo; Miguel-Angel Perales
Journal:  Blood Cancer J       Date:  2020-08-05       Impact factor: 11.037

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  2 in total

Review 1.  CAR T-Based Therapies in Lymphoma: A Review of Current Practice and Perspectives.

Authors:  Semira Sheikh; Denis Migliorini; Noémie Lang
Journal:  Biomedicines       Date:  2022-08-12

Review 2.  Efficacy and safety of CD19-directed CAR-T cell therapies in patients with relapsed/refractory aggressive B-cell lymphomas: Observations from the JULIET, ZUMA-1, and TRANSCEND trials.

Authors:  Jason R Westin; Marie José Kersten; Gilles Salles; Jeremy S Abramson; Stephen J Schuster; Frederick L Locke; Charalambos Andreadis
Journal:  Am J Hematol       Date:  2021-08-13       Impact factor: 13.265

  2 in total

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