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TRANSFORM Trial Shows Clinical Benefit With Liso-Cel
In a prespecified interim analysis of the TRANSFORM trial, the CAR-T therapy liso-cel showed superiority over standard of care as a second-line treatment for patients with LBCL.2
A total of 184 patients were randomly assigned 1:1 to either receive either intravenous fludarabine plus cyclophosphamide followed by liso-cel infusion or standard of care. Standard of care consisted of rituximab with dexamethasone, cytarabine, and cisplatin (R-DHAP); rituximab with ifosfamide, carboplatin, and etoposide phosphate (R-ICE); or rituximab with gemcitabine, cisplatin, and dexamethasone (R-GDP) followed by high-dose chemotherapy and hematopoietic stem cell transplantation (HSCT), at the investigator’s discretion.
Event-free survival (EFS) was the primary endpoint of the TRANSFORM study, with PFS and CR rates serving as key secondary endpoints. There were 92 patients assigned in each treatment arm, with the most common subtype of LBCL being diffuse large B-cell lymphoma.
Ultimately, after a median follow up of 17.5 months, the median EFS was not reached for the liso-cel arm and was 2.4 months for standard of care arm (stratified hazard ratio [HR] =0.356; 95% CI, 0.243-0.522).
Similarly, the median PFS per IRC was not reached for the liso-cel arm and was 6.2 months in patients who received standard of care (stratified HR=0.400; 95% CI, 0.261-0.615; P <.0001), “corresponding to a 60% reduction in risk of progression or death favoring liso-cel,” noted study presenter Jon E. Arnason, MD, of the Beth Israel Deaconess Medical Center in Boston, Massachusetts.
The 18-month EFS rate per IRC in the intent-to-treat set was 52.6% (95% CI, 42.3-62.9) in the liso-cel arm vs 20.8% (95% CI, 12.2-29.5) in the standard of care arm. The ORR was 87% (95% CI, 78.3-93.1) with liso-cel vs 49% (95% CI, 38.3-59.6) with standard of care. Additionally, the CR rate for liso-cel was 74% (95% CI, 63.7-82.5) vs 43% (95% CI, 33.2-54.2) with standard of care (P <.0001).
Of the 26 patients for whom the best overall response was a partial response at the time of the interim analysis, 6 patients from the liso-cel arm and 3 from the standard of care arm had their response deepen to a CR at the primary analysis.
The most common TEAEs included cytopenias, with serious TEAEs reported in 44 (48%) and 45 (49%) patients in the liso-cel and standard of care arms, respectively. Death due to TEAEs occurred in 2 patients in each arm. There were no grade 4/5 events reported in either arm.
“The primary analysis of the TRANSFORM study confirmed the superiority of liso-cel over standard of care,” Dr Arnason said. “Despite allowing for crossover, overall survival numerically favored liso-cel and a supportive overall survival analysis adjusting for the impact of crossover showed an overall survival benefit in favor of liso-cel. We conclude that these data support the use of liso-cel as a preferred second-line treatment for primary refractory or early relapsed [LBCL].”
This article originally appeared on Hematology Advisor
