Second-line lisocabtagene maraleucel (liso-cel) was associated with improved outcomes over standard of care (SOC) in patients with primary refractory or early relapsed large B-cell lymphoma (LBCL) in the phase 3 TRANSFORM study. Study results were reported in Blood.
The open-label trial (ClinicalTrials.gov Identifier: NCT03575351) enrolled adults who were eligible for autologous stem cell transplant (ASCT). The patients were randomly assigned 1:1 to receive either liso-cel (100×106 chimeric antigen receptor T cells) or SOC platinum-based immunochemotherapy for 3 cycles, with responders then receiving high-dose chemotherapy and ASCT. Crossover was allowed from the SOC arm to the liso-cel arm.
The intention-to-treat population included 92 patients in the liso-cel arm and 92 patients in the SOC arm. The median age was 60 years in the liso-cel arm and 58 years in the SOC arm, and 54% of patients in each study arm had stage 4 disease.
The median follow-up was 17.5 months. The complete response rate was 74% in the liso-cel arm and 43% in the SOC arm (P <.0001).
The median event-free survival (EFS) was not reached in the liso-cel arm and was 2.4 months in the SOC arm (hazard ratio [HR], 0.356; 95% CI, 0.243-0.522). The 18-month EFS rate was 52.6% in the liso-cel arm and 20.8% in the SOC arm. EFS favored the liso-cel arm across prespecified subgroups.
The median progression-free survival (PFS) was not reached in the liso-cel arm and was 6.2 months in the SOC arm (HR, 0.400; 95% CI, 0.261-0.615; P <.0001). The 18-month PFS rates were 58.2% for the liso-cel arm and 28.8% for the SOC arm.
The median overall survival (OS) was not reached in the liso-cel arm and was 29.9 months in the SOC arm (HR, 0.724; 95% CI, 0.443-1.183; P =.0987). The 18-month OS rate was 73.1% in the liso-cel arm and 60.6% in the SOC arm.
In a prespecified analysis adjusted for crossover, the median OS was not reached in either arm (HR, 0.415; 95% CI, 0.251-0.686). The 18-month OS rate was 73.1% in the liso-cel arm and 54.1% in the SOC arm.
Cytokine release syndrome (CRS) was reported in 49% of patients in the liso-cel arm, with grade 3 CRS occurring in 1%. Neurological events were seen in 11% of patients in the liso-cel arm, with grade 3 neurological events seen in 4%. None of the patients had grade 4 or 5 CRS or neurological events.
“With a median follow-up of 17.5 months, the primary analysis of the TRANSFORM study confirmed the superiority of liso-cel over SOC,” the researchers wrote.
Disclosures: This research was supported by Celgene. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Abramson JS, Solomon SR, Amason J, et al; for the TRANSFORM Investigators. Lisocabtagene maraleucel as second-line therapy for large B-cell lymphoma: Primary analysis of the phase 3 TRANSFORM study. Blood. 2023;141(14):1675-1684. doi:10.1182/blood.2022018730
This article originally appeared on Hematology Advisor