As reported in the Journal of Clinical Oncology by Kamdar et al, the 3-year follow-up of the phase III TRANSFORM trial showed that lisocabtagene maraleucel (liso-cel) maintained superior efficacy vs standard of care (SOC) in second-line treatment of relapsed/refractory large B-cell lymphoma (LBCL). In the primary analysis of the study, liso-cell significantly improved event-free survival vs SOC.
Study Details
In the global open-label trial, 184 adults eligible for autologous stem cell transplantation with primary refractory/early relapsed (≤ 12 months) disease were randomly assigned to receive liso-cel at 100 × 106 CAR+ T cells (n = 92) or SOC (n = 92). SOC consisted of three cycles of investigator choice of protocol-defined immunochemotherapy followed by high-dose chemotherapy and autologous stem cell transplantation in patients with complete or partial response.
Key Findings
At a median follow-up of 33.9 months, median event-free survival was 29.5 months (95% confidence interval [CI] = 9.5 months to not reached) in the liso-cel group vs 2.4 months (95% CI = 2.2–4.9 months) in the SOC group (hazard ratio [HR] = 0.375, 95% CI = 0.259–0.542); rates at 36 months were 46% vs 19%.
Median progression-free survival was not reached (95% CI = 12.6 months to not reached) in the liso-cel group vs 6.2 months (95% CI = 4.3–8.6 months) in the SOC group (HR = 0.422, 95% CI = 0.279–0.639); rates at 36 months were 51% vs 26.5%.
Median overall survival was not reached in either group (HR = 0.757, 95% CI = 0.481–1.191), with 66% of patients in the SOC group crossing over to receive liso-cel; rates at 36 months were 63% vs 52%. In an analysis accounting for the treatment effect of crossover, the hazard ratio for overall survival favored the liso-cel group (HR = 0.566, 95% CI = 0.359–0.895).
Safety profiles were consistent with previous reports.
The investigators concluded: “At 3-year follow-up, liso-cel confirmed superior, more durable efficacy vs SOC with a favorable safety profile and no new safety signals. These data support liso-cel as an effective second-line treatment with curative potential for relapsed/refractory LBCL.”
Manali Kamdar, MD, MBBS, of the University of Colorado Cancer Center, Aurora, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Celgene, a Bristol-Myers Squibb Company. For full disclosures of all study authors, visit the Journal of Clinical Oncology.
