The Absolute Effect / Oncology Evidence / Evidence Index

Large B-Cell Lymphoma · Medical · Relapsed / Refractory · Second-line primary refractory or early-relapsed LBCL ≤12 months · transplant eligible

TRANSFORM

In transplant-eligible primary refractory or early-relapsed large B-cell lymphoma, does second-line lisocabtagene maraleucel improve EFS over salvage chemotherapy and autologous transplantation?

Registry: NCT03575351 · Evidence reviewed 9 November 2026 · Aliases and follow-up publications consolidated.

Phase III randomized; n=184.Primary-source evidence summary

Study design, population and eligibility

Design and sample

Phase III randomized; n=184.

Population

Primary refractory or relapse ≤12 months after first-line therapy; eligible for ASCT.

Treatment and comparator

Intervention: Lisocabtagene maraleucel CAR-T, bridging therapy if needed.

Comparator: Platinum salvage immunochemotherapy then high-dose therapy/ASCT in responders.

Endpoints

EFS primary; CR/PFS key secondary.

Key efficacy and clinical outcomes

3-y follow-up: median EFS 29.5 vs 2.4 mo (HR .375); 36-mo EFS 46% vs 19%; primary-analysis CR 74% vs 43%; crossover 66%.

Source-reported outcome visualization

Values are reproduced from the cited report; bars are scaled within this figure. Second-line primary refractory or early-relapsed LBCL ≤12 months · transplant eligible

36-mo EFS liso-cel
46%
36-mo EFS SOC
19%

Median survival and hazard ratios are not fixed-time event risks; NNT is not inferred from them.

Toxicity and treatment burden

CRS and neurotoxicity; grade 3 CRS 1%, grade 3 neurologic events 4% in primary analysis; cytopenias/infections.

Absolute effect and NNT/NNH

Applies to transplant-eligible early relapse/primary refractory disease; not later relapse or transplant-ineligible population.

NNT/NNH is not calculated unless a directly reported, comparable fixed-time risk difference supports it. Median survival and hazard ratios alone do not provide an NNT.

Critical interpretation and limitations

Applies to transplant-eligible early relapse/primary refractory disease; not later relapse or transplant-ineligible population.

This page is an evidence summary, not a substitute for multidisciplinary assessment or patient-specific decision-making.

Current-practice context

Review date: 9 November 2026. Primary publication and selected follow-up sources were reviewed. Full disease-specific guideline, regulatory-label and sequencing audit remains pending; verify current local recommendations and biomarker eligibility before clinical application.

Primary publication and authoritative source

https://pubmed.ncbi.nlm.nih.gov/36542826/

ClinicalTrials.gov NCT03575351