All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the Lymphoma Coalition.

The Lymphoma Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy


Now you can personalise
your Lymphoma Hub experience!

Bookmark content to read later

Select your specific areas of interest

View content recommended for you

Find out more

The Lymphoma Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the Lymphoma Hub cannot guarantee the accuracy of translated content. The Lymphoma Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact
You're logged in! Click here any time to manage your account or log out.
You're logged in! Click here any time to manage your account or log out.

Lisocabtagene maraleucel as second-line therapy for adult patients with LBCL: Primary analysis of the phase III TRANSFORM trial

Mar 20, 2023
Learning objective: After reading this article, learners will be able to cite a new clinical development in LBCL.

Bookmark this article

For patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL), platinum-based immunochemotherapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT) has been the standard of care (SOC) second-line treatment protocol for many years. However, outcomes for these patients have historically been poor, with less than 30% of patients being cured. Recent data have indicated that these patients may benefit from chimeric antigen receptor (CAR) T-cell therapies as second-line treatment.

Lisocabtagene maraleucel (liso-cel) is an CD19-directed, autologous CAR T-cell product administered as equal doses of CD8+ and CD4+ CAR+ T-cells. Recent research has examined the role liso-cel may play in treating patients with R/R DLBCL as part of the TRANSFORM trial (NCT03575351).

Here, we summarize results from a primary analysis of the ongoing phase III TRANSFORM trial comparing the efficacy and safety of liso-cel to SOC in adult patients with high-risk, R/R, aggressive LBCL, presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition. These results were also published in Blood in December 2022.

Study design1

TRANSFORM is an ongoing, randomized, open label phase III trial of liso-cel vs SOC second-line therapy in adult patients with R/R LBCL. A total of 184 patients aged 18–75 years were selected for trial enrollment. Key enrollment criteria included positron emission tomography positive LBCL per Lugano 2014 criteria, R/R disease after CD20 antibody and anthracycline-containing first-line therapy, Eastern Cooperative Oncology Group Performance Status ≤1, adequate organ function, and eligibility for high-dose chemotherapy and ASCT.

All patients underwent leukapheresis before 1:1 randomization to liso-cel or SOC treatment arms. Patients randomized to liso-cel received lymphodepleting chemotherapy (fludarabine 30 mg/m2 and cyclophosphamide 300 mg/m2 daily for 3 days) followed by liso-cel infusion at a dose of 100 × 106 CAR T-cells. Patients randomized to SOC received three cycles of immunochemotherapy with response evaluated by positron emission/computed tomography scan after three cycles. Patients achieving a complete or partial response (CR or PR) moved on to high-dose chemotherapy and ASCT.

The primary efficacy endpoint was event-free survival (EFS). Key secondary efficacy endpoints included CR rate, progression-free survival (PFS), and overall survival (OS). Exploratory efficacy endpoints included EFS, CR rate, PFS, OS, overall response rate, and duration of response for crossover patients.

Safety endpoints included the type, frequency, and severity of adverse events (AE), serious AEs, and laboratory abnormalities.



Key efficacy outcomes are shown in Figure 1.

Figure 1. Efficacy outcomes for liso-cel versus SOC* 

EFS, event-free survival; liso-cel, lisocabtagene maraleucel; OS, overall survival; PFS, progression-free survival; SOC, standard of care.
*Adapted from Abramson, et al.1

  • Median EFS was not reached for liso-cel vs 2.4 months for SOC
  • EFS was found to favor liso-cel across all subgroups (prior response status, age, sex, Eastern Cooperative Oncology Group Performance Status, lactate dehydrogenase, prior computed tomography response status, disease subtype).
  • CR rate was 74% for liso-cel versus 43% for SOC
  • Median PFS was not reached for liso-cel versus 6.2 months for SOC
  • Median OS was not reached for liso-cel versus 29.9 months for SOC.
  • The secondary efficacy endpoints overall response rate, duration of response, and duration of CR were also shown to favor liso-cel


  • The most common treatment emergent AEs of any grade were neutropenia, anemia, thrombocytopenia, and nausea. The most common Grade ≥3 AEs in were neutropenia, thrombocytopenia, and anemia.
  • In total, 66 patients died during the trial (28 in the liso-cel arm and 38 in the SOC arm), with the most commonly reported cause of death being disease progression.
  • Rates of any-grade cytokine release syndrome (CRS) and neurological events were 49% and 11%, respectively, with Grade 3 CRS occurring in 1% and NEs occurring in 4% of patients.
  • Severe infections were reported in 15% of patients in the liso-cel arm and 21% in the SOC arm.


After a median follow-up of 17.5 months, this primary analysis of the TRANSFORM study confirms the superiority of liso-cel over SOC, with significant improvements in EFS, CR, and PFS observed in patients treated with liso-cel. The observed safety profile was comparable to previous studies, with low rates of any-grade and severe CRS and neurological events reported. These data further support the use of liso-cel as a second-line treatment for patients with primary refractory or early relapsed LBCL.

  1. Abramson JS, Solomon SR, Arnason JE et al. Lisocabtagene maraleucel as second-line therapy for large B-cell lymphoma: primary analysis of phase III TRANSFORM study. Blood. 2022. Online ahead of print. DOI: 1182/blood.2022018730
  2. Abramson JS. Lisocabtagene maraleucel (liso-cel) versus standard of care (SOC) with salvage chemotherapy followed by autologous stem cell transplantation (ASCT) as second-line (2L) treatment in patients with relapsed or refractory large B-cell lymphoma (LBCL): Primary analysis of the randomized, phase 3 Transform study. Oral abstract #655. 64th American Society of Hematology Annual Meeting and Exposition; Dec 11, 2022; New Orleans, US.

Understanding your specialty helps us to deliver the most relevant and engaging content.

Please spare a moment to share yours.

Please select or type your specialty

  Thank you


Subscribe to get the best content related to lymphoma & CLL delivered to your inbox